WHO Warns of Counterfeit Ozempic in the Global Supply Chain-Here's What to Know.

This Medical News article discusses reports of falsified semaglutide being found around the world.

Federal Enforcement of Pharmaceutical Fraud under the False Claims Act, 2006-2022.

CONTEXT: The False Claims Act is the US federal government's primary tool for identifying and penalizing pharmaceutical fraud. The Department of Justice uses the False Claims Act to bring civil cases against drug manufacturers that allegedly obtain improper payment from federal programs. METHODS: The authors searched the Department of Justice website for press releases published between 2006 and 2022 that announced fraud actions brought against drug companies. They then used the World Health Organization's Anatomical Therapeutic Classification index to identify the classes of prescription drugs implicated in fraud actions. FINDINGS: During fiscal years 2006-2022, payments by six manufacturers amounted to more than 28% of total payments made as a result of federal False Claims Act actions. Nervous system and cardiovascular drugs were the classes of medications most commonly implicated in alleged fraud. Federal officials most frequently alleged that companies improperly promoted nervous system drugs and paid kickbacks to increase revenues from cardiovascular, antineoplastic and immunomodulating, and alimentary tract and metabolism drugs. CONCLUSIONS: Despite frequent pharmaceutical fraud settlements and penalties, incidence of alleged fraud among drug companies remains high. Alternative methods for preventing and deterring fraud could help safeguard our health systems and promote public health, and policy makers should ensure that effective fraud enforcement complements preventive public health regulation.

Case Studies of Fraud Associated with the Use of Radiation Sources: Practical Avoidance Strategies Based on Lessons Learned.

ABSTRACT: Periodically the radiation protection profession has experienced purposeful deception practices that remained undetected for some time. Upon discovery, the cases of fraud revealed gaps in confirmation or validation practices that the radiation protection community should note. Summarized here is a convenience sample of actual cases of fraud involving radiation sources along with the exploited process vulnerabilities. Recommended process improvements that the radiation safety community may consider are presented to improve the collective fidelity of radiation protection processes.

An Affordable NIR Spectroscopic System for Fraud Detection in Olive Oil.

Adulterations of olive oil are performed by adding seed oils to this high-quality product, which are cheaper than olive oils. Food safety controls have been established by the European Union to avoid these episodes. Most of these methodologies require expensive equipment, time-consuming procedures, and expert personnel to execute. Near-infrared spectroscopy (NIRS) technology has many applications in the food processing industry. It analyzes food safety and quality parameters along the food chain. Using principal component analysis (PCA), the differences and similarities between olive oil and seed oils (sesame, sunflower, and flax oil) have been evaluated. To quantify the percentage of adulterated seed oil in olive oils, partial least squares (PLS) have been employed. A total of 96 samples of olive oil adulterated with seed oils were prepared. These samples were used to build a spectra library covering various mixtures containing seed oils and olive oil contents. Eighteen chemometric models were developed by combining the first and second derivatives with Standard Normal Variable (SNV) for scatter correction to classify and quantify seed oil adulteration and percentage. The results obtained for all seed oils show excellent coefficients of determination for calibration higher than 0.80. Because the instrumental aspects are not generally sufficiently addressed in the articles, we include a specific section on some key aspects of developing a high-performance and cost-effective NIR spectroscopy solution for fraud detection in olive oil. First, spectroscopy architectures are introduced, especially the Texas Instruments Digital Light Processing (DLP) technology for spectroscopy that has been used in this work. These results demonstrate that the portable prototype can be used as an effective tool to detect food fraud in liquid samples.

Healthcare Fraud Data Mining Methods: A Look Back and Look Ahead.

Healthcare fraud is an expensive, white-collar crime in the United States, and it is not a victimless crime. Costs associated with fraud are passed on to the population in the form of increased premiums or serious harm to beneficiaries. There is an intense need for digital healthcare fraud detection systems to evolve in combating this societal threat. Due to the complex, heterogenic data systems and varied health models across the US, implementing digital advancements in healthcare is difficult. The end goal of healthcare fraud detection is to provide leads to the investigators that can then be inspected more closely with the possibility of recoupments, recoveries, or referrals to the appropriate authorities or agencies. In this article, healthcare fraud detection systems and methods found in the literature are described and summarized. A tabulated list of peer-reviewed articles in this research domain listing the main objectives, conclusions, and data characteristics is provided. The potential gaps identified in the implementation of such systems to real-world healthcare data will be discussed. The authors propose several research topics to fill these gaps for future researchers in this domain.

Multifunctional Probes with High Utilization Rates: Self-Assembled Merocyanine Nanoparticles in Water as Acid-Base Indicators and Mitochondrion-Targeting Chemotherapeutic Agents.

Multifunctional probes with high utilization rates have great value in practical applications in various fields such as cancer diagnosis and therapy. Here we have synthesized two organic molecules based on merocyanine. They can self-assemble in water to form ∼1.5 nm nanoparticles. Both of them have good application potential in fluorescent anticounterfeit printing ink and pH detection. More importantly, they have excellent mitochondrial targeting ability, intracellular red light and near-infrared dual-channel imaging ability, strong antiphotobleaching ability, and in vivo and in vitro near-infrared imaging capabilities, showing superior chemotherapy capabilities and biocompatibility in the 4T1 tumor-bearing mouse model.

Standardization of a rapid quadruplex PCR method for the simultaneous detection of bovine, buffalo, Salmonella spp, and Listeria monocytogenes DNA in milk / [Padronização de um método rápido de PCR quadriplex para a detecção simultânea de DNA de bovino, bubalino, Salmonella spp. e Listeria monocytogenes em leite]

The objective of the present study was to Standardize a Polymerase Chain Reaction (PCR) protocol for the authentication of bovine and buffalo milk, and to detect the presence of Salmonella spp. and Listeria monocytogenes. For this, the target DNA was extracted, mixed, and subjected to a PCR assay. Milk samples were defrauded and experimentally contaminated with microorganisms to assess the detection of target DNA at different times of cultivation, bacterial titers, and concentration of genetic material. In addition, the protocol was tested with DNA extracted directly from food, without a pre-enrichment step. The proposed quadruplex PCR showed good accuracy in identifying target DNA sequences. It was possible to simultaneously identify all DNA sequences at the time of inoculation (0h), when the samples were contaminated with 2 CFU/250mL and with 6h of culture when the initial inoculum was 1 CFU/250mL. It was also possible to directly detect DNA sequences from the food when it was inoculated with 3 CFU/mL bacteria. Thus, the proposed methodology showed satisfactory performance, optimization of the analysis time, and a potential for the detection of microorganisms at low titers, which can be used for the detection of fraud and contamination.

O objetivo do presente estudo foi padronizar um protocolo de reação em cadeia da polimerase (PCR) para a autenticação de leite bovino e bubalino e a detecção da presença de Salmonella spp. e Listeria monocytogenes. Para isso, o DNA-alvo foi extraído, misturado e submetido ao ensaio de PCR. Amostras de leite foram fraudadas e contaminadas experimentalmente com os micro-organismos, para se avaliar a detecção do DNA-alvo em diferentes tempos de cultivo, os títulos bacterianos e a concentração de material genético. Além disso, o protocolo foi testado com DNA extraído diretamente do alimento, sem a etapa de pré-enriquecimento. A PCR quadriplex proposta mostrou boa precisão na identificação de sequências de DNA-alvo. Foi possível identificar simultaneamente todas as sequências de DNA no momento da inoculação (0h), quando as amostras estavam contaminadas com 2 UFC/250mL, e com seis horas de cultura, quando o inóculo inicial foi de 1 UFC/250mL. Também foi possível detectar diretamente as sequências de DNA do alimento quando este foi inoculado com 3 UFC/mL de bactérias. Dessa forma, a metodologia proposta apresentou desempenho satisfatório, otimização do tempo de análise e potencial para detecção de micro-organismos em baixos títulos, podendo ser utilizada para detecção de fraude e contaminação.

Stimuli-Responsive Metal-Organic Framework on a Metal-Organic Framework Heterostructure for Efficient Antibiotic Detection and Anticounterfeiting.

Stimuli-responsiveness is an important characteristic that show promising potential in various applications. Herein, a novel ZIF-8-on-Tb-dpn (H3dpn = 5-(2',4'-dicarboxylphenyl)nicotic acid) heterostructure is constructed using a heteroepitaxial strategy combining the chemical-responsive (antibiotics) and light-responsive behaviors. The pyridine nitrogen of Tb-dpn acts as an anchor site for Zn2+, which helps to overcome the limit of lattice mismatch between two metal-organic frameworks (MOFs) and promotes the growth of ZIF-8 nanocrystals. Based on the synergy effect of two MOFs, ZIF-8-on-Tb-dpn exhibits an efficient turn-off response toward tetracycline and chloramphenicol via competitive absorption, Förster resonance energy transfer, and photoinduced electron transfer processes with limit of detection values of 5.6 and 37.6 nM, respectively, which are three- to -fivefold lower than those of Tb-dpn. Moreover, the nanocage of ZIF-8 is utilized to encapsulate photochromic spiropyran (SP) molecules and realize the reversible conversion between SP and merocyanine (MC) under visible light and ultraviolet light. The MC form is accompanied with strong adsorption at 555 nm, which can erase the emission of Tb3+. Therefore, a reversible invisible anticounterfeiting pattern is designed with SP ⊂ ZIF-8-on-Tb-dpn for information anticounterfeiting. The excellent stimuli-responsive ability makes the luminescent platform a potential candidate in luminescence applications.

Detection of camellia oil adulteration using chemometrics based on fatty acids GC fingerprints and phytosterols GC-MS fingerprints.

The fatty acid, squalene, and phytosterols, coupled to chemometrics were utilized to detect the adulteration of camellia oil (CAO) with palm superolein (PAO), refined olive oil (ROO), high oleic- sunflower oil (HO-SUO), sunflower oil (SUO), corn oil (COO), rice bran oil (RBO), rice oil (RIO), peanut oil (PEO), sesame oil (SEO), soybean oil (SOO), and rapeseed oil (RAO). CAO was characterized with higher triterpene alcohols, thus differentiated from other vegetable oils in principle component analysis (PCA). Using partial least squares-discriminant analysis (PLS-DA), CAO adulterated with PAO, ROO, HO-SUO, SUO, COO, RBO, RIO, PEO, SEO, SOO, RAO (5%-100%, w/w), could be classified, especially higher than 92.31% of the total discrimination accuracy, at an adulterated ratio above 30%. With less than 22 potential key markers selected by the variable importance in projection (VIP), the optimized PLS models were confirmed to be accurate for the adulterated level prediction in CAO.

A field trials-based authentication study of conventionally and organically grown Chinese yams using light stable isotopes and multi-elemental analysis combined with machine learning algorithms.

In this study, stable isotopes and multi-element signatures combined with chemometrics were used to distinguish conventional and organic Chinese yams based on field trials. Four light stable isotopes δD, δ13C, δ15N, δ18O, and 20 elements (e.g. Li, Na, Mn) were determined, then evaluated using significance analysis and correlation analysis, and modeling of various chemometrics methods. Consequently, the RandomForest model showed the best performance with AUC value of 0.972 and predictive accuracy of 97.3%, and Mn, Cr, Se, Na, δD, As, and δ15N were screened as significant variables. Moreover, many chemical components and antioxidant activity of yam samples were determined spectrophotometrically. The results indicated that organic yams had advantages in secondary metabolites such as polyphenol, flavonoid and saponin; conversely, conventional samples had more primary metabolites like protein and amino acids. Above all, this work provides a beneficial case in the authentication and quality evaluation of conventional and organic yams.

Estratégias adotadas na América do Sul para a gestão da infodemia da COVID-19 / COVID-19 infodemic management strategies in South America / Estrategias adoptadas en América del Sur para la gestión de la infodemia relacionada con la COVID-19

RESUMO Objetivo. Identificar a existência ou ausência de estratégias para a gestão de infodemia nos ministérios da saúde de 10 países da região da América do Sul (Brasil, Argentina, Uruguai, Paraguai, Bolívia, Peru, Chile, Colômbia, Equador, Venezuela). Métodos. Definiu-se "estratégia" como o uso planejado de recursos para atingir ou concretizar determinados objetivos — sendo, neste caso, considerado como objetivo o combate à infodemia. Os sites eletrônicos oficiais dos ministérios da saúde dos países foram examinados de 28 de setembro a 10 de outubro de 2020 em busca de materiais, páginas eletrônicas ou aplicativos que sugerissem a existência de uma estratégia de combate à infodemia; informações sobre infodemia para cidadãos; e materiais comunicacionais como vídeos e cartazes. Ainda, utilizando "infodemia" como palavra-chave, foram buscados documentos oficiais (normativas, decretos, protocolos) que mencionassem medidas relacionadas à gestão da infodemia. Os resultados foram classificados em três categorias: existência de estratégia de gestão; existência de alguma ação de combate à infodemia; e ausência de informação sobre infodemia. Resultados. Dos 10 países analisados, apenas a Argentina possuía uma estratégia destinada à gestão da infodemia. Brasil, Chile, Equador e Paraguai apenas faziam menção ao tema no site de seus respectivos ministérios da saúde; e nenhuma menção foi encontrada nos sites dos ministérios da saúde de Bolívia, Colômbia, Peru, Uruguai e Venezuela. Conclusões. Os países estudados não fazem uso do conhecimento disponível acerca de estratégias de combate e gestão da infodemia.

ABSTRACT Objective. To identify evidence of infodemic management strategies in the ministry of health websites in 10 South American countries (Brazil, Argentina, Uruguay, Paraguay, Bolivia, Peru, Chile, Colombia, Ecuador, Venezuela). Method. "Strategy" was defined as the planned use of resources to achieve of materialize certain objectives — in this case, fighting the infodemic. The official ministry of health websites in each country were examined from 28 September to 10 October 2020 in search of materials, electronic pages or apps suggesting the existence of an infodemic management strategy, information about the infodemic for citizens, and communication materials such as videos and posters. Additionally, using "infodemic" as a keyword, official documents (rulings, decrees, protocols) mentioning infodemic management measures were searched. The results were classified into three categories: existence of an infodemic management strategy; existence of infodemic control actions; absence of information on the topic. Results. Of the 10 countries analyzed, only Argentina had an infodemic management strategy. Infodemic was mentioned as a topic in the ministry of health websites in Brazil, Chile, Ecuador, and Paraguay; and no mention was identified in the ministry of health websites in Bolivia, Colombia, Peru, Uruguay, and Venezuela. Conclusions. The studied countries do not make use of the available knowledge regarding infodemic management strategies.

RESUMEN Objetivo. Determinar la existencia o la falta de estrategias para la gestión de la infodemia en los Ministerios de Salud de diez países de América del Sur (Argentina, Bolivia, Brasil, Colombia, Chile, Ecuador, Paraguay, Perú, Uruguay y Venezuela). Métodos. Se definió el término "estrategia" como el uso planificado de recursos para alcanzar o concretar determinados objetivos y, para este último fin, se fijó como objetivo la lucha contra la infodemia. Del 28 de septiembre al 10 de octubre del 2020, se examinaron los sitios electrónicos oficiales de los Ministerios de Salud de los países en busca de materiales, páginas electrónicas o aplicaciones que indicaran la existencia de una estrategia para combatir la infodemia, datos sobre la infodemia para la ciudadanía y materiales de comunicación como videos y carteles. Con el término "infodemia" como palabra clave, se buscaron documentos oficiales (directrices, decretos y protocolos) que mencionaran medidas relacionadas con la gestión de la infodemia. Los resultados se clasificaron en tres categorías: la existencia de una estrategia de gestión, la existencia de alguna medida para combatir la infodemia y la falta de datos sobre la infodemia. Resultados. Entre los diez países analizados, solamente Argentina tenía una estrategia destinada a la gestión de la infodemia. Brasil, Chile, Ecuador y Paraguay apenas mencionaban el tema en el sitio web de sus respectivos Ministerios de Salud; y no se encontró ninguna mención en los sitios web de los Ministerios de Salud de Bolivia, Colombia, Perú, Uruguay y Venezuela. Conclusiones. Los países estudiados no utilizan el conocimiento disponible acerca de las estrategias para combatir y gestionar la infodemia.

Función de los profesionales de la salud de rectificar la información errónea que tienen los pacientes más allá de corregir los hechos / Roles for Health Care Professionals in Addressing Patient-Held Misinformation Beyond Fact Correction

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Experiences With Counterfeit Aesthetic Medical Devices and Injectables: A National Survey.

BACKGROUND: Counterfeit medical devices and injectables have recently garnered interest in the field of aesthetics. Unlike their original counterparts, these counterfeit products have neither been tested nor verified using certified quality control measures. OBJECTIVE: Our study investigated the pervasiveness of counterfeit products in the field as well as the experiences and attitudes of practitioners. MATERIALS AND METHODS: An online survey was distributed to current members of the American Society for Dermatologic Surgery (ASDS) and the American Society for Laser Medicine and Surgery (ASLMS). RESULTS: For medical devices, 37.4% have encountered counterfeits and 20.1% have experienced patients with adverse events from them. For injectables, 41.1% have encountered counterfeits and 39.7% have experienced patients with adverse events from them. Compared with their original, most respondents believe that counterfeits are worse in terms of reliability, safety, and effectiveness. The majority also believe that counterfeits are either very or extremely endangering to patient safety. CONCLUSION: Counterfeit medical devices and injectables are not uncommonly encountered. Overall, practitioners believe counterfeits are endangering patient safety and result in adverse events and think that either stricter rules and regulations or better enforcement of existing regulations is necessary.

Detection of fraud by addition cow's milk in cheese buffalo and its connection with seasonality / Detecção de fraude por adição de leite de vaca em queijo de búfala e a relação com a sazonalidade

The seasons influence the production of buffalos' milk. Because of this, the producers may produce a mixture of buffalo and bovine milk during cheese production in periods of low production. Therefore, the present work aimed to investigate fraud in buffalo cheese and the relationship between seasonality and different physicochemical properties of buffalo cheeses produced and marketed in eastern Amazonia. We obtained commercial samples of buffalo cheese during two Amazonian climatic periods from commercial points of Marajó-Pará, Brazil. After collection, there were lipid, protein, ash, and humidity analyses. Determination of carbohydrates and energy values was also performed for the nutritional characterization of samples, as well as for mPCR analysis to detect buffalo and/or bovine DNA. DNA extraction protocol of the samples was standardized and two pairs were used for the mPCR reaction, amplifying fragments of approximately 220 bp for Bubalus bubalis DNA and 346 bp fragments for Bos taurus DNA. Among the samples acquired in the rainy season, we observed that 33% were inadequately labeled, indicating fraud from cow's milk incorporation and fraud from substitution of raw material. From the nine samples obtained in the dry season, all the samples showed cow's milk incorporation fraud. The highest fraud rate coincided with the period of low milk production from buffalo and there was a difference in composition between fraudulent and non-fraudulent cheeses. Therefore, seasonality influences increase in cattle milk for the production of buffalo cheese, and this adulteration may decrease the nutritional content of the product.

As estações climáticas influenciam a produção de leite de búfala. Isso pode levar os produtores a misturarem os leites de búfala e bovino durante a produção de queijo em períodos de baixa produção. Portanto, o presente trabalho teve como objetivo verificar fraudes em queijo de búfala, a relação com a sazonalidade e as diferenças físico-químicas de queijos de origem bubalina, produzidos e comercializados no leste da Amazônia. Foram coletadas amostras comerciais de queijo de búfala em dois períodos climáticos da Amazônia em pontos comerciais do Marajó-Pará, Brasil. Após a coleta foram realizadas análises de lipídios, proteínas, cinzas e umidade. A determinação dos carboidratos e do valor energético também foi feita para a caracterização nutricional das amostras, bem como a análise de mPCR para a detecção de DNA de búfalo e/ou bovino. Para isso, padronizou-se um protocolo de extração de DNA das amostras e utilizou-se dois pares na reação mPCR, amplificar fragmentos de aproximadamente 220 pb para o DNA de Bubalus bubalis e fragmentos de 346 pb para o Bos taurus. Entre as amostras adquiridas na estação chuvosa, observou-se que 33% foram rotuladas inadequadamente, caracterizando fraude por incorporação de leite de vaca e fraude por substituição de matéria-prima. Das 9 amostras coletadas no período seco, todas as amostras apresentaram fraude na incorporação do leite de vaca. Este estudo revelou que a maior taxa de fraude coincide com o período de baixa produção de leite e que há uma diferença na composição entre queijos fraudulentos e não fraudulentos. Portanto, a sazonalidade influencia no acréscimo de leite de bovinos na produção de queijo de búfala e que esta adulteração pode diminuir o conteúdo nutricional do produto.

Mini submersible pump assisted sonochemical reactors: Large-scale synthesis of zinc oxide nanoparticles and nanoleaves for antibacterial and anti-counterfeiting applications.

Low cost, environmentally friendly and industrial-scale approaches for the synthesis of anti-counterfeiting and antibacterial materials are a challenging task. The current research reports novel and inexpensive approaches for the synthesis of zinc oxide nanostructures (ZnO-NSs) using Mini Submersible Pump (MSP) assisted sonochemical reactors. Zinc oxide nanoleaves (ZnO-NLs) were synthesized using MSP assisted sonochemical mixing reactor at gram-scale (4 g). Zinc oxide nanoparticles (ZnO-NPs) were synthesized using MSP assisted sonochemical flow loop reactor at gram-scale (11.5 g). Synthesized ZnO-NSs were characterized by UV-visible spectroscopy, fluorescence spectroscopy, XRD, FTIR, TGA, BET, FEG-SEM, and FEG-TEM. Bare ZnO-NPs and ZnO-NPs coated cotton fabric showed high antibacterial activity against diseases causing Gram-positive bacteria Staphylococcus aureus. Based on the UV fluorescence property of the ZnO-NLs, invisible security ink was developed for anti-counterfeiting applications. The invisible security ink was tested as a rubber stamp and fountain pen inks which were found to be stable on the various kinds of microporous papers. As compared to our previously reported method, disperser assisted sonochemical approach for ZnO-NLs synthesis; the current approach reduces the cost of equipment used from ∼1700 to 4 USD. Both reactors are designed simply (less complicated), based on an environmentally friendly approach, highly scalable, increases the effectiveness of the sonochemical technique and suitable for industrial applications.