Conflict of interest policies at Australian medical schools.

BACKGROUND: Pharmaceutical industry exposure is widespread during medical training and may affect education and clinical decision-making. Medical faculties' conflict of interest (COI) policies help to limit this exposure and protect students against commercial influence. AIMS: Our aim was to investigate the prevalence, content and strength of COI policies at Australian medical schools and changes since a previous assessment conducted in 2009. METHODS: We identified policies by searching medical school and host university websites in January 2021, and contacted deans to identify any missed policies. We applied a modified version of a scorecard developed in previous studies to examine the content of COI policies. All data were coded in duplicate. COI policies were rated on a scale from 0 (no policy) to 2 (strong policy) across 11 items per medical school. Oversight mechanisms and sanctions were also assessed, and current policies were compared with the 2009 study. RESULTS: Of 155 potentially relevant policies, 153 were university-wide and two were specific to medical schools. No policies covered sales representatives, on-site sponsored education or free samples. Oversight of consultancies had improved substantially, with 76% of schools requiring preapproval. Disclosure policies, while usually present, were weak, with no public disclosure required. CONCLUSION: We found little indication that Australian medical students are protected from commercial influence on medical education, and there has been limited COI policy development within the past decade. More attention is needed to ensure the independence of medical education in Australia.

Direito à saúde, tratamentos experimentais e indústria farmacêutica: breves anotações / Right to health, experimental treatments and pharmaceutical industry: brief notes / Derecho a la salud, tratamientos experimentales y industria farmacéutica: brevesnotas

Objetivo: compreender o excesso de judicialização no Brasil e buscar algumas justificativas que levaram ao estado da arte. Metodologia: utilizou-se o método de pesquisa indutivo, realizando um levantamento bibliográfico e análise documental, com base em dados divulgados pelo Conselho Nacional de Justiça e, de forma complementar, em dados extraídos do sítio institucional da Agência Nacional de Saúde Suplementar. Resultados: a judicialização da saúde tem apresentado um caráter predominantemente individual, o que agrava o alcance da macrojustiça e do atendimento da coletividade. Além disso, as dificuldades estruturais do Sistema Único de Saúde tornam-se cada vez mais evidentes. Observa-se que a judicialização da saúde pode ser perversa do ponto de vista do excesso de concessão de tutelas de urgência, da prioridade da justiça individualizada e do destaque da microjustiça; elementos que prejudicam o funcionamento do sistema de saúde como um todo. Conclusão: a indústria farmacêutica apresenta intensa participação no processo de incorporação de medicamentos. No entanto, a complexidade e demora das etapas procedimentais da incorporação dessas novas tecnologias, não raro, resultam em demandas judiciais que derivam decisões polêmicas e nem sempre acertadas. Todo esse desenho acaba por desencadear pressão no órgão competente de incorporação, incompreensões sobre o funcionamento do SUS e fortalecimento da microjustiça.

Objective: to understand the excess of judicialization in Brazil and seek some justifications that led to the state of the art. Methods: an inductive research method was used, which involved conducting a bibliographic survey and documentary analysis of data released by the National Council of Justice and, in addition, data extracted from the institutional website of the National Supplementary Health Agency. Results: the judicialization of health has presented a predominantly individual aspect, which aggravates the reach of macrojustice and community care. In addition, the structural difficulties of the Unified Health System become increasingly evident. The judicialization of health can be perverse from the point of view of the excess of granting emergency guardianships, the priority of individualized justice, the prominence of microjustice; elements that undermine the functioning of the health system as a whole. Conclusion: the pharmaceutical industry plays an intense role in the drug incorporation process. However, the complexity and delay in the procedural stages of incorporating these new technologies often result in legal demands that result in controversial decisions that are not always correct. This entire design ends up triggering pressure on the competent incorporation body, misunderstandings about the functioning of the SUS and strengthening microjustice.

Objetivo: comprender el exceso de judicialización en Brasil y buscar algunas justificaciones que han llevado al estado del arte. Metodología: se utilizó el método de investigación inductivo, realizando un levantamiento bibliográfico y análisis documental, con base en datos divulgados por el Consejo Nacional de Justicia y, de forma complementaria, en datos extraídos del sitio web institucional de la Agencia Nacional de Salud Complementaria. Resultados: la judicialización de la salud ha presentado un carácter predominantemente individual, lo que agrava el alcance de la macrojusticia y de la atención de la colectividad. Además, las dificultades estructurales del Sistema Único de Salud son cada vez más evidentes. Se observa que la judicialización de la salud puede ser perversa desde el punto de vista de la concesión excesiva de tutelas de urgencia, de la prioridad de la justicia individualizada y del énfasis en la microjusticia; elementos que perjudican el funcionamiento del sistema de salud em su conjunto. Conclusión: la industria farmacéutica juega un papel intenso en el proceso de incorporación de medicamentos. Sin embargo, la complejidad y demora en las etapas procesales de incorporación de estas nuevas tecnologías derivan muchas veces en exigencias legales que derivan en decisiones controvertidas y no siempre correctas. Todo este diseño termina provocando presiones sobre el órgano constitutivo competente, malentendidos sobre el funcionamiento del SUS y fortalecimiento de la microjusticia.

[Evolutions of the "framework of benefits" system]. / Évolutions du dispositif « encadrement des avantages ¼.

EVOLUTIONS OF THE "FRAMEWORK OF BENEFITS" SYSTEM. In the field of compliance, the last thirty years have been marked by an evolution of the regulatory framework in order to adapt an anti-corruption system to the whole ecosystem of health professionals and industrialists. Although the various developments now make the "framework of benefits" a solid legislative construction, the latest news shows the need to move towards a reinforcement of illegal practices as well as a framework of canvassing for promotion between industrialists and health professionals. However, the construction of this legal framework has given rise to concerns and questions, particularly from physicians' associations, concerning their training prospects and their search for funding.

ÉVOLUTIONS DU DISPOSITIF « ENCADREMENT DES AVANTAGES ¼. Dans le champ de la compliance (ou conformité), les trente dernières années ont été marquées par une évolution du cadre réglementaire afin d'adapter un dispositif anticorruption à l'ensemble d'un écosystème de professionnels de santé et d'industriels. Si les différentes évolutions font désormais du dispositif « Encadrement des avantages ¼ une construction législative solide, les dernières actualités montrent la nécessité de tendre vers un renforcement de l'encadrement des pratiques illégales ainsi qu'un encadrement du démarchage à la promotion entre les industriels et les professionnels de santé. La construction de ce cadre juridique a toutefois été à l'origine d'inquiétudes et de questionnements, notamment des associations de médecins concernant leurs perspectives de formation et leur recherche de financements.

Automedicación en profesionales de un laboratorio farmacéutico paraguayo / Self-medication among professionals in a Paraguayan pharmaceutical company

Objetivo: determinar la prevalencia de la automedicación entre las personas trabajadoras de un laboratorio farmacéutico del área metropolitana de Asunción (Paraguay) y describir sus características.Método: estudio descriptivo transversal (nov 2016). Se incluyó a todas las personas adultas trabajadoras del laboratorio (N= 400). Se solicitó su participación por correo electrónico en dos ocasiones. Se midieron variables sociodemográficas, laborales y la automedicación mediante cuestionario heteroadministrado diseñado ad hoc y pilotado (síntomas que motivaron, frecuencia, grupo de fármaco, motivos, fuente de la recomendación, eficacia y peligro percibido, finalización, acción en caso de persistencia del síntoma, publicidad, lugar de compra, fuentes de información). Se realizó estadística descriptiva y bivariante.Resultados: participaron 166 personas (edad media 33,2 años; 60,2% hombres). El 34,3% se había automedicado en los tres meses anteriores. El 90,4% consideraba que la automedicación era peligrosa. La práctica de automedicación fue mayor en el nivel universitario que en el secundario (44,8% vs. 22,8%; p= 0,004). No se encontraron diferencias en función de la edad, el sexo, ni el tiempo trabajado en la empresa. La causa más frecuente fue el tratamiento del dolor de cabeza (64,9%) y los fármacos más consumidos, los analgésicos/antiinflamatorios (82,4%). El 66,6% no consideró necesario ir al médico para la prescripción y en el 35,1% de los casos fue el familiar o amigo quien lo recomendó.Conclusiones: la automedicación fue una práctica habitual en la población estudiada, aunque inferior a otros estudios. Es necesario el abordaje de este problema.(AU)

Objective: to determine the prevalence of self-medication among the persons working at a pharmaceutical company from the metropolitan area of Asunción (Paraguay), and to describe its characteristics.Method: a descriptive cross-sectional study (November 2016). All adult persons working at the company were included (N= 400). Their participation was requested by email in two occasions. Sociodemographic and occupational variables were measured, as well as self-medication, through a self-administered questionnaire, designed ad hoc and piloted (symptoms causing it, frequency, drug class, reasons, source of recommendation, efficacy and perceived danger, conclusion, action in case of symptom persistence, publicity, place of purchase, sources of information). Descriptive and bivariate statistics was conducted.Results: the study included 166 persons (mean age 33.2 years; 60.2% were male). Of these, 34.3% had self-medicated within the past three months; 90.4% considered that self-medication was dangerous. Self-medication was higher with university than with high school level (44.8% vs. 22.8%; p= 0.004). No differences were found based on age, gender or time worked at the company. The most frequent cause was treatment for headache (64.9%) and the drugs more widely used were analgesics / anti-inflammatories (82.4%); 66.6% of the participants did not consider it was necessary to see their doctor for prescription, and they followed recommendations by relatives or friends in 35.1% of cases.Conclusions: self-medication was a frequent practice among the population studied, although lower than in other studies. It is necessary to address this problem.(AU)

Do doctors have a responsibility to help patients import medicines from abroad?

Almost any medicine can be purchased online from abroad. Many high-income countries permit individuals to import medicines for their personal use. However, those who import medicines face the risk of purchasing poor-quality products that may not work, or that may even harm them. Many people are willing to accept this risk for the opportunity to purchase more affordable medicines. This is especially true of individuals from low socioeconomic backgrounds who already struggle to afford the medicines they need if they are not subsidised by insurers or if copayments are high. As medicine prices and out-of-pocket healthcare spending continue to climb, the online marketplace provides an important alternative for individuals in high-income countries to source medicines. In this article, I argue that doctors have a responsibility to help patients access medicines online and I propose a framework that can be used to facilitate responsible personal importation.

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines.

An increasing proportion of new drugs approved for market worldwide are now high cost, specialty medicines. Pharmaceutical marketers face the challenge of convincing payers, prescribers, and patients that the cost and complexity of care associated with specialty medicines is worth the trouble, and now offer patient support programs, free of charge, to patients prescribed their drug. We conducted a secondary, qualitative, interpretive analysis of 24 interviews with leaders of patient groups and members of hospital formulary committees in Australia to describe the work of pharmaceutical company-employed or contracted nurses who provide support to patients prescribed specialty medicines, and to prompt discussion around the policy implications of relying on industry-funded nursing care within publicly funded health systems. Participants affirmed the value of specialist, holistic, person-centered nursing care, but perceived gaps within the public health system related to the availability and provision of nursing care for people living with chronic disease. Consequently, participants described the pharmaceutical industry as addressing health system gaps through sponsorship or direct provision of medication-related nursing care, but recognized that care was contingent on commercial interest. Participants highlighted a number of ethical and policy concerns stemming from industry-funded nursing care of people prescribed specialty medicines related to patient safety, continuity of care, inducement to prescribe, and health equity. This analysis suggests that outsourcing necessary medication-related care to pharmaceutical companies has implications for the health system and equitable, sustainable pharmaceutical policy that extend far beyond the care encounter.

Medicines legislation and regulation in the United Kingdom 1500-2020.

The initial purposes of regulation of medicines in England, and latterly in the United Kingdom, were principally to raise government revenue, to discourage murder by poisoning and to regulate the activities of pharmacists. It was only much later that regulators sought to ensure that medicines were of good quality, reasonably safe, and at least somewhat effective, and to curtail misuse of drugs. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics.

A Content Analysis of Self-Reported Financial Relationships in Biomedical Research.

INTRODUCTION: Financial conflicts of interest (fCOI) present well documented risks to the integrity of biomedical research. However, few studies differentiate among fCOI types in their analyses, and those that do tend to use preexisting taxonomies for fCOI identification. Research on fCOI would benefit from an empirically-derived taxonomy of self-reported fCOI and data on fCOI type and payor prevalence. METHODS: We conducted a content analysis of 6,165 individual self-reported relationships from COI statements distributed across 378 articles indexed with PubMed. Two coders used an iterative coding process to identify and classify individual fCOI types and payors. Inter-rater reliability was κ = 0.935 for fCOI type and κ = 0.884 for payor identification. RESULTS: Our analysis identified 21 fCOI types, 9 of which occurred at prevalences greater than 1%. These included research funding (24.8%), speaking fees (20.8%), consulting fees (18.8%), advisory relationships (11%), industry employment (7.6%), unspecified fees (4.8%), travel fees (3.2%), stock holdings (3.1%), and patent ownership (1%). Reported fCOI were held with 1,077 unique payors, 22 of which were present in more than 1% of financial relationships. The ten most common payors included Pfizer (4%), Novartis (3.9%), MSD (3.8%), Bristol Myers Squibb (3.2%), AstraZeneca (3.1%), GSK (3%), Boehringer Ingelheim (2.9%), Roche (2.8%), Eli LIlly (2.5%), and AbbVie (2.4%). CONCLUSIONS: These results provide novel multi-domain prevalence data on self-reported fCOI and payors in biomedical research. As such, they have the potential to catalyze future research that can assess the differential effects of various types of fCOI. Specifically, the data suggest that comparative analyses of the effects of different fCOI types are needed and that special attention should be paid to the diversity of payor types for research relationships.

Teaching medical students how to interact with the pharmaceutical industry: A scoping review.

Objectives: The influence of the pharmaceutical industry is of significant concern in physician prescribing decisions; medical students may not be fully equipped with the knowledge or skills to manage interactions with industry prior to graduation. The aim of this study was to evaluate the characteristics of educational interventions undertaken to improve students' knowledge, attitudes, and skills in managing interactions with the pharmaceutical industry. Methods: A systematic search of Ovid Medline, EMBASE, CINAHL and ERIC databases identified 3210 primary studies with keywords related to "pharmaceutical industry" and "undergraduate medical education". Eleven articles were included for review. Results: Disparate methods of teaching medical students how to interact with the pharmaceutical industry were identified, making it difficult to compare the effectiveness of different educational interventions. All the included studies achieved the aims of the described intervention, at least in the short term, suggesting perhaps any education related to interactions with the pharmaceutical industry can aid students in managing these situations. Conclusions: The lack of an evidence-base means more research into the identification of educational interventions which engender durable changes in students' knowledge, attitudes, and skills to manage interactions with the pharmaceutical industry are required. Any intervention will likely be context-dependent, as a universal approach is hindered by the fact different countries have different laws governing pharmaceutical industry-physician interaction.

Marketing Antipsychotics to Correctional Facilities: A Review of Pharmaceutical Industry Documents.

This retrospective qualitative review describes the marketing of antipsychotics by pharmaceutical companies to prisons and jails to increase prescribing. This review relied on internal pharmaceutical industry documents released in litigation and stored in the Drug Industry Documents archive at the UCSF Industry Documents Library. At least two pharmaceutical companies directly marketed antipsychotics to correctional facilities to increase sales, using targeted promotions and indirect "educational" advertising and by seeking control of state advisory boards that made formulary decisions. Further research on how medications are marketed is needed, along with stronger conflict-of-interest policies to reduce industry involvement on advisory boards that approve medications. National regulations that restrict pharmaceutical manufacturers from involvement in formulary decisions and prescribing guidelines would likely improve the provision of health care to people who are incarcerated.

Current practices for QSP model assessment: an IQ consortium survey.

Quantitative Systems Pharmacology (QSP) modeling is increasingly applied in the pharmaceutical industry to influence decision making across a wide range of stages from early discovery to clinical development to post-marketing activities. Development of standards for how these models are constructed, assessed, and communicated is of active interest to the modeling community and regulators but is complicated by the wide variability in the structures and intended uses of the underlying models and the diverse expertise of QSP modelers. With this in mind, the IQ Consortium conducted a survey across the pharmaceutical/biotech industry to understand current practices for QSP modeling. This article presents the survey results and provides insights into current practices and methods used by QSP practitioners based on model type and the intended use at various stages of drug development. The survey also highlights key areas for future development including better integration with statistical methods, standardization of approaches towards virtual populations, and increased use of QSP models for late-stage clinical development and regulatory submissions.

Physician Payments from Pharmaceutical Companies Related to Cancer Drugs.

BACKGROUND: Drug manufacturers claim that the purpose of financial payments to physicians is to facilitate education about new drugs. This claim suggests 2 testable hypotheses: payments should not be associated with drug revenue and payments for each drug should decline over time as physicians become educated. MATERIALS AND METHODS: We used open payments data on industry payments. We included payments for cancer drugs without generic/biosimilar competitors and used federal data sources to measure Medicare spending (a proxy for overall drug revenue) and a number of prescribers. We used generalized estimating equations (GEE) to model the drug-level association between industry payments and Medicare spending. Separately, we used GEE to estimate the change in payments with respect to the duration of time since initial FDA approval. RESULTS: The sample included 89 drugs and 361 drug-year observations. The total value of industry payments for oncology drugs increased, from $53 333 854 in 2014 to $90 343 731 in 2018. There was no association between log-transformed mean, per-physician industry payments, and per-physician Medicare spending (estimate -0.001, 95%CI, -0.005 to 0.004). Payments for individual drugs decreased over time; estimated payments in the subsequent year for a drug with mean, per-physician payments of $1000 in the index year was: $681* for drugs 0-4 years since approval, $825 for 5-9 years, and $679* for ≥10 years (*P < .05). CONCLUSIONS: Although industry-sponsored education may also serve marketing purposes, the absence of association between industry payments and Medicare spending and the decline in payments subsequent to approval are consistent with claims that industry payments function to facilitate physician education.

Caracterización de las aguas residuales generadas en la producción de conjugados monovalentes en el Instituto Finlay de Vacunas / Characterization of the wasteswater generated in the production of conjugated monovalent at the Finlay Vaccine Institute

En la actualidad la contaminación de las aguas terrestres es un grave problema ambiental. La industria farmacéutica es una de las que produce un mayor impacto por la gran variedad de químicos que aporta al agua; sus efluentes generalmente tienen asociadas elevadas cargas orgánicas no biodegradables. La preservación de la calidad de las aguas terrestres es un tema regulado por la legislación nacional, donde se exige la caracterización de las aguas residuales antes de su vertimiento con vistas a evaluar el impacto ambiental que producen y diseñar el sistema adecuado para su tratamiento. El Instituto Finlay de Vacunas, pertenece al grupo de BioCubaFarma, es una empresa de ciclo completo, cuenta con nueve instalaciones, cinco de ellas son generadoras de grandes volúmenes de aguas residuales industriales. El presente trabajo tiene el objetivo de presentar los resultados obtenidos en la evaluación de los parámetros físico-químico de los residuales líquidos del proceso productivo de conjugados monovalentes, para esto se muestrearon los residuales líquidos generados al final de cada etapa del proceso. Se determinaron los indicadores de contaminación: pH, temperatura, conductividad eléctrica, demanda química y bioquímica de oxígeno, fósforo total, nitrógeno total y sólidos sedimentables; los ensayos fueron realizados en el laboratorio de la Empresa Nacional de Servicios Técnicos de la Habana, acreditado para la realización de las caracterizaciones de aguas residuales. Los resultados fueron comparados con los límites máximos permisibles establecidos en la Norma Cubana NC-27:2012 de vertimiento de aguas residuales al alcantarillado, además se calculó el índice de biodegradabilidad. Se demostró que el pH, la conductividad eléctrica, demanda química de oxígeno y demanda bioquímica de oxígeno no cumplen con el vertido para la descarga al alcantarillado pudiendo impactar de manera negativa en los recursos hídricos(AU)

At present, the pollution of terrestrial waters is a serious environmental problem. The drug industry is one of those that produces a greater impact, due to the great variety of chemicals that can contribute to the water; its effluents generally have associated high non-biodegradable organic loads. The preservation of the quality of terrestrial waters is a subject regulated by legislation, where the characterization of wastewater is required before its discharge, since it allows evaluating the environmental impact it produces and designing the appropriate system for its treatment. The Finlay Vaccine Institute, belongs to the BioCubaFarma group, is a full cycle company, has nine facilities, five of them are generators of large volumes of industrial wastewater. The current work presents the results obtained in the evaluation of the physical-chemical parameters of the liquid waste from the production process of monovalent conjugates, for this the liquid waste generated at the end of each stage of the process was sampled. Pollution indicators were determined: pH, temperature, electrical conductivity, chemical and biochemical oxygen demand, total phosphorus, total nitrogen and sedimentable solids. The results were compared with the maximum permissible limits established in NC-27: 2012 for the discharge of wastewater. The biodegradability index was also calculated. It was shown that some of the determined parameters do not comply with the discharge to release to the sewer system, which could have a negative impact on water resources(AU)

Drivers of medicalization in the Canadian Adult Obesity Clinical Practice Guidelines.

The new Canadian Adult Obesity Clinical Practice Guidelines frame higher body weight as a chronic, relapsing disease requiring comprehensive medical treatment pathways. In this commentary, we will demonstrate how a process called pharmaceuticalization is informing the new guidelines. We join those questioning the normalization of industry and medical collaboration and interrogate whether the new guidelines meaningfully address stigma.

RéSUMé: Les nouvelles Lignes directrices canadiennes de pratique clinique de l'obésité chez l'adulte présentent le poids corporel élevé comme une maladie chronique récurrente nécessitant un parcours de soins médicaux complet. Dans notre commentaire, nous montrerons que ces nouvelles lignes directrices sont éclairées par un processus de « pharmaceuticalisation ¼. Nous joignons notre voix aux personnes qui remettent en question la normalisation de la collaboration entre l'industrie et la médecine, et nous nous demandons si les nouvelles lignes directrices abordent utilement la stigmatisation.

Ensaios clínicos em congressos médicos: estudo sobre conflito de interesses / Clinical trials in medical congresses: a study on conflicts of interest / Ensayos clínicos en congresos médicos: un estudio sobre conflicto de intereses

Resumo Este artigo busca investigar conflitos de interesses envolvendo a apresentação de ensaios clínicos em congressos brasileiros de cinco especialidades médicas, ocorridos entre 2004 e 2018. Foram estudados 407 resumos em 22 anais. Após aplicar critérios de seleção, obteve-se um corpus de 77 ensaios. Detectou-se maior frequência de conflitos de interesses envolvendo ensaios com drogas para as quais não havia genéricos/similares ( p =0,000), sendo que em 48% daqueles em conflito de interesses não houve declaração. Os resultados favoráveis à droga-teste ocorreram em 90,9% do total de ensaios, mas em 48,6% deles não foi reportado valor de p . As categorias terapêuticas mais testadas foram imunossupressores e imunomoduladores, antidiabéticos e antineoplásicos, que, juntas, representaram 68,9% do total de drogas envolvidas. Os resultados apontam conflitos de interesses ocultos, supervalorização de resultados positivos de drogas-testes, nem sempre com evidências suficientes, e concentração de produção em drogas de alto custo.

Abstract This article seeks to investigate conflicts of interest involving the presentation of clinical trials in Brazilian congresses of five medical specialties between 2004 and 2018. A total of 407 abstracts in 22 annals were studied. After applying selection criteria, we reached a corpus of 77 essays. A higher frequency of conflicts of interest was found involving essays with drugs for which no generic/similar option was available (p=0.000), and 48% of those with a conflict of interest declared nothing. Favorable results to the test drug occurred in 90.9% of the total of essays, but 48.6% of them lacked the p-value. The most tested therapeutic categories were immunosuppressors and immunomodulators, antidiabetic, and antineoplastic, which, together, amounted to 68.9% of the total of the involved drugs. The results pointed to hidden conflicts of interest, overvaluing of positive results of test drugs, not always with sufficient evidence, and focus of production on high-cost drugs.

Resumen Este artículo analiza los conflictos de intereses en ensayos clínicos presentados en congresos brasileños de cinco especialidades médicas, realizados entre 2004 y 2018. Se analizaron 407 resúmenes de 22 anales. Tras aplicados los criterios de selección se obtuvo un corpus de 77 ensayos. Hubo una mayor frecuencia de conflictos de intereses en ensayos con medicamentos para los que no había medicaciones genéricas/similares ( p =0,000), y el 48% con conflictos no hubo su declaración. Los resultados favorables para droga prueba están en el 90,9% del total de ensayos, pero el 48,6% de ellos no informó el valor de p . Las categorías terapéuticas más probadas fueron inmunosupresores e inmunomoduladores, antidiabéticos y antineoplásicos, que juntas compusieron el 68,9% del total de fármacos. Los resultados apuntan a conflictos de intereses ocultos, sobreestimación de los resultados positivos de las drogas prueba, no siempre con evidencia suficiente, y concentración de la producción en medicamentos de alto costo.

A Proposal to Increase Value and Equity in the Development and Distribution of New Pharmaceuticals.

The process of developing and marketing new pharmaceuticals in the United States is driven by a need to maximize returns to shareholders. This results all too often in the production of new medications that are expensive and of marginal value to patients and society. In line with our heightened awareness of the importance of social justice and public health-and in light of our government's alliance with private companies in bringing us COVID-19 vaccines-we need to reconsider how new pharmaceuticals are developed and distributed. Accordingly, we propose the creation of a new agency of the Food and Drug Administration (FDA) that would direct the whole process. This agency would fund the research and development of high-value medications, closely monitor the clinical studies of these new drugs, and manage their distribution at prices that are value-based, fair, and equitable.

Adverse Impacts of Imposing International Economic Sanctions on Health.

BACKGROUND: International economic sanctions (IES) influence a country's economic development and the overall welfare of a nation's population. METHODS: An electronic search of PubMed, Embase and Web of Science was conducted until July 31, 2019. Additionally, a list of references to related articles was reviewed. Key search terms were "Economics", "Health", "Sanction", and their equivalents with no language or time restriction. RESULTS: Totally, 8624 records were identified of which 2869 duplicates were deleted. Finally, 24 papers met the inclusion criteria and were selected for drafting. The number of papers included for evaluating each factor included healthcare (n=16) and pharmaceutical industry (n=10). Nine and eight studies examined the effect of sanctions imposed on Iran and Iraq, respectively. France, Haiti, Serbia, Cuba, Syria, and other areas such as Africa were also evaluated. Sanctions lead to a decrease in immunization rates and government health care expenditures. Sanctions increase infant and under-five mortality rate, road traffic injuries and fatalities, severe malnutrition, infective diseases, neurologic and visual disorders, as well as shortage of medical or dental instruments and a variety of medicines. Sanctions have adverse impacts on female labor and are associated with disabling hospitals, dispersing medical workers, and facilities for radiation therapy. CONCLUSION: The health status of sanctioned nations in terms of healthcare, and pharmaceutical industry was adversely affected in targeted countries.

Transformación digital en la relación entre industria y colectivo sanitario / Digital transformation of the relationship between industry and healthcare professionals

La pandemia por COVID-19 ha afectado gravemente a la dinámica de los sistemas de salud y ha tenido consecuencias muy negativas en la atención sanitaria. Sin embargo, ha impulsado en mayor o menor medida la transformación digital en muchos centros sanitarios y en la industria farmacéutica. En este artículo se revisa la experiencia de la transformación digital derivada de la pandemia desde la perspectiva de los profesionales sanitarios y de la industria farmacéutica, con énfasis en la teleconsulta, en la formación a distancia y en el modelo de interacción entre sanitarios e industria. Además, se dan algunas claves para llevar a cabo una transformación digital exitosa (AU)

The COVID-19 pandemic has affected healthcare systems severely and has had a negative impact on healthcare. However, it has also been a catalyst for digital transformation in many healthcare centers and in the pharmaceutical industry. In this article, the experience of digital transformation during the pandemic is reviewed from the perspective of healthcare professionals and the pharmaceutical industry, with a focus on digital visits, on-line education, and the model of interaction between healthcare professionals and the industry. Also, some key points are given to facilitate a successful digital transformation (AU)

Medical Representatives' User Acceptance of Remote e-Detailing Technology: A Moderated Mediation Analysis of Technology Acceptance Model.

OBJECTIVE: E-detailing methods have steadily evolved toward more contactless and interactive channels, which have received considerable attention during the coronavirus disease 2019 (COVID-19) crisis. Based on the technology acceptance model, this study attempted to identify medical representatives' perceptions and attitudes towards individual innovativeness that affected users' intentions to adopt new e-detailing devices utilizing information and communication technology. METHODS: The subjects of the current study were medical representatives at three major multinational or domestic pharmaceutical companies that operate in South Korea. In total, 300 questionnaires were distributed and 221 were returned. The survey elicited information on respondents' perceived ease of use (PEOU), perceived usefulness (PU), personal innovativeness (PI), and user acceptance (UA) of remote e-detailing technology, in addition to demographic information and occupational characteristics. Structural equation models were fitted to the data. Separate analyses were conducted for different platform types, PCs and mobile devices. RESULTS: PEOU showed a statistically significant positive association with PU. PEOU, PU, and PI were associated with UA, and PI was a statistically significant moderator. On average, PEOU explained up to approximately 45% of the total variation in UA of remote e-detailing. CONCLUSIONS: The analysis supports the framework of the technology acceptance model. PEOU was a substantially strong direct predictor of UA, and PI had a statistically significant, positive moderating effect between PU and UA. Medical representatives with pro-innovative attitudes are more likely to play the role of early adopters of remote e-detailing if they find this technology to be more useful.

COVID-19 vaccines: a look at the ethics of the clinical research involving children.

Currently, millions of minors are being inoculated against SARS-CoV-2 in many countries in the world. Ethical concerns about clinical research involving children have barely been addressed in the literature, despite the fact that the paediatric population is particularly vulnerable within this context. Children should be included in the research plans for COVID-19 vaccines. Nevertheless, it is necessary to critically assess to what extent clinical trials are being conducted according to methodological and ethical criteria that allow us to conclude that the results are valid and, in consequence, how far the vaccination plans for children are scientifically justified.The principal aim of this article is to analyse critically the process of clinical research on COVID-19 vaccines involving children, highlighting the ethical concerns that arise, including the need to stratify the results from older adolescents separately for analysis before proceeding, if further research is warranted, in descending age order. The development of COVID-19 vaccines is examined, with a special look at the participation of children throughout their clinical development, including a review of the clinical trials registered in three international databases. We also offer some additional considerations about the inclusion of minors in vaccination plans. Finally, we conclude with some recommendations, with particular emphasis on the following ethical duties: research in children should be carried out only once the relevant research in adults has previously been conducted; issues that concern children's needs and rights should be specifically addressed; and, therefore, the highest standards of ethical and scientific quality should be met.