Medicamentos para artrite reumatoide fornecidos pelo Sistema Único de Saúde em 2019 no Brasil: estudo de coorte / Drugs for rheumatoid arthritis provided by the Unified Health System in 2019 in Brazil: a cohort study

Resumo Este artigo tem como objetivo analisar características do fornecimento e fatores associados ao tratamento da artrite reumatoide no Brasil, com foco nos medicamentos biológicos modificadores do curso da doença (MMCDbio). Foi realizado um estudo retrospectivo com dados secundários do Sistema de Informação Ambulatorial do Sistema Único de Saúde. Foram incluídos pacientes com 16 anos ou mais, atendidos nos doze meses do ano de 2019. As análises foram feitas com fatores de exposição em relação aos desfechos: uso de MMCDbio e porte populacional. O estudo incluiu 155.679 pacientes, sendo 84,6% mulheres. Observou-se maior troca de MMCDbio e maior provisão de médicos reumatologistas nos municípios de maior porte (mais de 500 mil habitantes). Quase 40% dos pacientes utilizaram MMCDbio e estes apresentaram maior adesão ao tratamento (57,0% versus 64%, p=0,001). A dispensação de MMCDbio ocorreu para mais de um terço dos pacientes tratados para AR no Brasil e esteve associada ao maior percentual de disponibilidade de médicos reumatologistas e ao maior porte populacional dos municípios.

Abstract This study analyzes supply characteristics and factors associated with the treatment of rheumatoid arthritis in Brazil, with a focus on disease course-modifying biological drugs (bioDMARDs). A retrospective study was conducted with secondary data from the Outpatient Information System of the Unified Health System. Patients aged 16 years or older who were treated in 2019 were eligible. The analyses were performed with exposure factors in relation to the outcomes: bioDMARD use and population size. The study included 155,679 patients, 84.6% of whom were women. There was a greater exchange of bioDMARDs and a greater supply of rheumatologists in the larger municipalities (more than 500,000 inhabitants). Almost 40% of the patients used bioDMARDs, and they showed greater adherence to treatment (57.0% versus 64%, p=0.001). The dispensing of bioDMARDs occurred in more than one-third of the patients treated for rheumatoid arthritis (RA) in Brazil and was associated with a higher percentage of availability of rheumatologists and larger population size.

Análise preliminar do uso de biológicos no tratamento da artrite reumatoide / Preliminary analysis for the use of biologicals in the treatment of rheumatoid arthritis

Introdução: A artrite reumatoide é tratada com drogas modificadoras da doença convencionais e biológicas. Objetivos: Comparar a sobrevida de medicamentos biológicos utilizados para o tratamento de pacientes com artrite reumatoide. Método: Estudo retrospectivo de prontuários de pacientes que utilizaram medicamento biológico para tratamento de artrite reumatoide de janeiro de 2020 a janeiro de 2022 e este foi suspenso. Dados acerca das causas de retirada, tempo de uso, dados epidemiológicos, clínicos e de comorbidades foram coletados. Resultados: O principal motivo da descontinuidade foi a falha seguida por efeitos colaterais. Infliximabe e adalimumabe foram os que apresentaram maior sobrevida. Índice de massa corporal e o tabagismo, sexo e idade não mostraram interferência nesta sobrevida Conclusão: Falha é a causa mais comum de descontinuidade dos biológicos. Dentre os fatores estudados (fumo, indice de massa corporal, idade e sexo) não foi possível identificar variável que se associasse com falha.

Introduction: Rheumatoid arthritis is treated with conventional and biological disease-modifying drugs. Objectives: To compare the survival of biological drugs used for the treatment of rheumatoid arthritis patients. Methods: Retrospective study of medical records of patients who used biological medication for the treatment of rheumatoid arthritis from January 2020 to January 2022 and this was suspended. Data on the causes of withdrawal, duration of use, epidemiological, clinical and comorbid data were collected. Results: The main reason for discontinuity was failure followed by side effects. Infliximab and adalimumab had the highest survival. Body mass index and smoking, sex and age did not interfere in this survival. Conclusion: Failure is the most common cause of biological discontinuity. Among the factors studied (smoking, body mass index, age and gender) it was not possible to identify a variable that was associated with failure.

Depleción de eosinófilos: muchas implicaciones en modelos múridos, pocas estudiadas en humanos / Eosinophil depletion: many implications in murine models, few studied in humans

The eosinophil is a cell of the immune system, with an arsenal of substances that can alter the balance that exists in the different organs where they are found. With the advent of monoclonal antibodies, concern about their depletion has become an important turning point in their formulation. For this reason, it is of vital importance to investigate the consequences of the mechanism of action of biological agents, in the short and long term. This review tries to show the role of eosinophils in both homeostasis and disease, and their relationship and interaction with monoclonal drugs in diseases focused on the Th2 profile. It is expected that this article can be useful when making the decision to start treatment with monoclonals, specifically anti-interleukin-5 or against its receptor

Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity

Biological drugs, such as proteins and immunogens, are increasingly used to treat various diseases, including tumors and autoimmune diseases, and biological molecules have almost completely replaced synthetic drugs in rheumatology. Although biological treatments such as anti-tumor necrosis factor (TNF) drugs seem to be quite safe, they cause some undesirable effects, such as the onset of infections due to weakening of the immune system. Given the biological nature of these drugs, they might be recognized as extraneous; this would induce an immune reaction that neutralizes their effectiveness or lead to more serious consequences. Laboratories play a pivotal role in appropriate therapeutic management. The aim of this review was to underline the production of anti-drug antibodies during treatment with biological drugs and highlight the role of laboratories in ensuring appropriate use of these drugs.

Application of biomarkers in clinical development of biologics and bioanalytical strategies / 中国临床药理学与治疗学

China's biologic drug research and development is on a fast track lane. The rising cost of new drug development has not improved the success rate of drug launch, and a shift in the model of drug development is urgently needed. In order to improve the success rate, a biomarker strategy of the new drug development model has been proposed and is generally accepted. This paper reviews the research and development of new translational medicine drugs with biomarkers as the core, the application of biomarkers in the clinical study of biological drugs, biomarker biological analysis strategies, and the opportunities and challenges of biomarkers in the clinical study of biological drugs. By comparing international standards, seeking China's advantages and seeking opportunities from the research and development model of translational medicine based on biomarkers, China can make innovative drugs with global influence in the near term.

Consenso sobre riesgo de complicaciones infecciosas en pacientes usuarios de medicamentos biológicos seleccionados. Parte I / Consensus of infectious complications in patients treated with selected biological therapies: first Part

Resumen La incorporación de terapias biológicas ha significado un gran avance en el manejo de diversas patologías de origen autoinmune, neoplásico u otros. Si bien su uso ha implicado mejoras significativas en el pronóstico de estas enfermedades, no está exento de complicaciones, entre estas, las infecciosas. El objetivo de este consenso fue evaluar el perfil de seguridad, desde la mirada infectológica, de las terapias biológicas de uso más frecuente y dar recomendaciones para la prevención de infecciones en pacientes tratados con ellas, basándose en la evidencia de mayor calidad disponible para los biológicos seleccionados. El consenso cuenta de dos manuscritos. Esta primera parte detalla los riesgos de desarrollar complicaciones infecciosas dependiendo del tipo de biológico utilizado para determinada patología. La revisión incluyó búsqueda amplia en MEDLINE y Epistemonikos de revisiones sistemáticas y meta-análisis de estudios clínicos controlados y caso/control que examinaban infecciones posteriores al tratamiento con anti-TNF alfa, anti-CD20, anti-CD52, CTLA4-Ig y anti-integrinas. Esta búsqueda se complementó con revisión de cohortes multicéntricas de usuarios de biológicos, del MMWR del CDC, Atlanta, E.U.A. y de registros nacionales y/o de sociedades científicas en la que se hiciera mención a complicaciones infecciosas derivadas del uso de biológicos.

The use of biological therapies has meant a great improvement in the management of several conditions like autoimmune, neoplastic or others diseases. Although its use has implied significant improvements in the prognosis of these diseases, it is not exempt from complications: infectious diseases as one of them. The objective of this consensus was to evaluate, from an infectious viewpoint, the safeness of the most frequently used biological therapies and give recommendations for the prevention of infections in patients treated with these drugs. These recommendations were based on the highest quality evidence available for the selected biologics. The consensus counts of two manuscripts. This first part details the risks of developing infectious complications depending on the type of biological used for a certain pathology. This evaluation included a broad search in MEDLINE and Epistemonikos of systematic reviews and meta-analyzes of controlled clinical trials and casecontrol examining post-treatment infections with anti-TNF alpha, anti-CD20, anti-CD52, CTLA4-Ig and anti-integrins. The research was complemented by a review of: multicentre cohorts of biological users, the MMWR of the CDC, Atlanta, U.S.A., and national registers and scientific societies in which infectious complications derived from the use of biological therapies were mentioned.

Consenso sobre riesgo de complicaciones infecciosas en pacientes usuarios de medicamentos biológicos seleccionados. Parte II: Guía clínica chilena de Prevención de Infecciones Asociadas al Uso de Terapias Biológicas (PREVITEB) / Consensus of infectious complications in patients treated with selected biological therapies. Screening of hepatitis B in high risk Chilean and immigrant pregnant women: Management of mother to child transmission Second part: Chilean Guidelines for Prevention of Infections associated to use of Biological Therapies (PREVITEB)

Resumen La incorporación de terapias biológicas ha significado un gran avance en el manejo de diversas patologías de origen autoinmune, neoplásico u otros. Si bien su uso ha implicado mejoras significativas en el pronóstico de estas enfermedades, no está exento de complicaciones, entre éstas, las infecciosas. El objetivo de este consenso fue evaluar el perfil de seguridad, desde la mirada infectológica, de las terapias biológicas de uso más frecuente y dar recomendaciones para la prevención de infecciones en pacientes tratados con ellas, basándose en la evidencia de mayor calidad disponible para los biológicos seleccionados. El consenso cuenta de dos manuscritos. Esta segunda parte corresponde a la guía clínica que detalla estas recomendaciones mediante estrategias de cribado, terapias profilácticas e indicación de vacunas, según corresponde, para infecciones bacterianas, y por micobacterias en particular, virus, hongos y parásitos, tanto para adultos como para niños.

The use of biological therapies has meant a great improvement in the management of several conditions like autoimmune, neoplastic or others diseases. Although its use has implied significant improvements in the prognosis of these diseases, it is not exempt from complications: infectious diseases as one of them. The objective of this consensus was to evaluate, from an infectious viewpoint, the safeness of the most frequently used biological therapies and give recommendations for the prevention of infections in patients treated with these drugs. These recommendations were based on the highest quality evidence available for the selected biologics. The consensus counts of 2 manuscripts. This second part is a guideline that details these recommendations through screening strategies, prophylactic therapies and vaccines indications for bacterial, mycobacterial, viral, fungal and parasitic infections, both for adults and children.

Guia prático de atualização: medicamentos biológicos no tratamento da asma, doenças alérgicas e imunodeficiências / Practical update guide: biological drugs in the treatment of asthma, allergic diseases and immunodeficiencies

O presente guia apresenta revisão extensa sobre imunobiológicos utilizados, liberados e ainda sob estudo, para o tratamento da asma, doenças alérgicas e imunodeficiências. Além das características físico-químicas de alguns desses fármacos, são revisadas as indicações e os resultados de estudos clínicos realizados para avaliar eficácia e segurança. Separados por doença específica, são apresentados os principais agentes disponíveis e aprovados para utilização segundo as normas regulatórias nacionais.

This guide presents an extensive review of immunobiological drugs used, approved and/or under investigation for the treatment of asthma, allergic diseases and immunodeficiencies. In addition to the physicochemical characteristics of some of these drugs, their indications and results of clinical studies evaluating efficacy and safety are reviewed. The main agents available and approved for use in each specific disease according to national regulatory standards are presented.

Colombian Association of Rheumatology. Consensus on recommendations to decrease and discontinue biological therapy in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis / Asociación Colombiana de Reumatología. Consenso sobre recomendaciones para disminución y descontinuación de la terapia biológica en pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica

A B S T R A C T Objective: The objective of this study was to establish recommendations for the reduction and discontinuation of biological disease-modifying antirheumatic drugs, with the aim of becoming a guide document for health professionals involved in the management of patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. Materials and methods: The recommendations were established through consensus by a panel of experts in rheumatology, and based on the analysis of available scientific evidence obtained from systematic reviews and the clinical experience of the panellists. Results: A total of 33 rheumatoid arthritis related studies were included, with 6 psoriatic arthritis related, and 9 ankylosing Spondylitis related. The recommendations for the reduction of biological therapies were made by establishing a plan to determine when and how to reduce the biological disease-modifying antirheumatic drugs in patients with these 3 diseases, and in some cases lead to the discontinuation of these treatments. Conclusion: The recommendations established in this document will serve as a guide to improve the efficiency of biological therapy in these diseases, reduce the variability in clinical practice, and establish an adequate risk/benefit ratio.

RESUMEN Objetivo: El objetivo de este estudio fue establecer recomendaciones para la disminución y descontinuación de la terapia biológica con el fin de que se convierta en un documento guía para los profesionales de la salud involucrados en el manejo de pacientes con artritis reumatoide, espondilitis anquilosante y artritis psoriásica. Materiales y métodos: Las recomendaciones fueron establecidas mediante consenso desarrollado a través de un panel de expertos en reumatología, basado en el análisis de la evidencia científica disponible obtenida de revisiones sistemáticas y sobre la experiencia clínica de los panelistas. Resultados: Se incluyeron 33 estudios relacionados con artritis reumatoide, 6 de artritis psoriásica y 9 de espondilitis anquilosante. Las recomendaciones para la disminución de las terapias biológicas se realizaron estableciendo un plan para determinar cuándo y cómo reducir los fármacos biológicos modificadores de enfermedades reumáticas en pacientes con estas 3 enfermedades y en algunos casos conducir a la descontinuación de estos tratamientos. Conclusión: Las recomendaciones establecidas en este documento servirán de guía para mejorar la eficiencia de la terapia biológica en estas enfermedades, reducir la variabilidad en la práctica clínica y establecer de manera adecuada una relación riesgo/beneficio.

The production of biopharmaceuticals in Brazil: current issues

Biopharmaceuticals are gaining a growing share of the pharmaceuticals market. In recent years, the Brazilian Health Surveillance Agency (ANVISA) has approved the registration of biological drugs with domestic production. Although Brazil is in the early stages of biopharmaceutical production, governmental incentives and the investment in private companies in the technological domain in this country have created expectations of an increase in the capacity of biopharmaceutical production. Private initiatives, once rare, have now started to blossom in this field, such as collagenase from Cristalia and filgrastim from Eurofarm. The expiry of the patents for certain biopharmaceuticals (e.g. infliximab, filgrastim and rituximab) has generated the possibility of savings to the Brazilian National Health System (SUS) in terms of biosimilars and incentives for national production. National production could also avoid dependence on external imports and a lack of essential supplies. In the next few years, Brazil is expected to bring nationally produced biopharmaceuticals to the market. Although there is some way to go before Brazil will be able to sustain the national demand for biopharmaceuticals and supply international markets with new products, the country is starting to take its first steps towards these objectives.

Complicaciones asociadas a tratamiento biológico en pacientes con artritis reumatoide: consideraciones en relación a un caso clínico / Associated complications with biological treatment in patients with rheumatoid arthritis: considerations in relation to a clinical case

La artritis reumatoide (AR) es una enfermedad inflamatoria sistémica de origen autoinmune, caracterizada por una evolución variable, con remisiones y reacti-vaciones. Se considera que un diagnóstico y tratamiento precoz permiten evitar el daño articular, mejorar el pronóstico y la calidad de vida del paciente. El trata-miento actual está basado en el uso de fármacos antirreumáticos sintéticos mo-dificadores de la enfermedad (sDMARDS), asociado a glucocorticoides en dosis bajas. Frente al fracaso o intolerancia de este tratamiento o bien en casos de una enfermedad inicial muy severa, en especial con manifestaciones extraarticulares, se recomienda el uso de fármacos biológicos modificadores de la enfermedad (bDMARD). Estos fármacos, usados en las condiciones señaladas, han significado un avance importante en el control y pronóstico de la enfermedad. Sin embargo, no están exentos de la presencia de reacciones adversas, por lo que deben ser monitorizados permanentemente.

Rheumatoid arthritis (RA) is a systemic inflammatory disease of autoimmune ori-gin, characterized by a variable evolution, with remissions and reactivations. It is considered that a diagnosis and early treatment allow avoiding the joint damage, improving the prognosis and the quality of life of the patient. The current treat-ment is based on the use of synthetic antirheumatic drugs modifying the disease (sDMARDS), associated with low-dose glucocorticoids. Faced with the failure or intolerance of this treatment or in cases of a very severe initial disease, especially with extra-articular manifestations, the use of biological drugs that modify the disease (bDMARD) is recommended. These drugs, used in the indicated condi-tions, have meant an important advance in the control and prognosis of the dis-ease. However, they are not exempt from the presence of adverse reactions, so they should be monitored permanently.

A fascinating story of the discovery & development of biologicals for use in clinical medicine

A young physician starting a fresh career in medicine in this millennium would hardly stop to think about the genesis of a particular biological drug that he/she will be prescribing for a patient evaluated in the morning outpatient department. For him/her, this is now routine, and the question of ‘Who’, ‘How’ and ‘When’ about these biologicals would be the last thing on their mind. However, for those who came to the medical profession in the 1950s, 1960s and 1970s, these targeted drugs are nothing short of ‘miracles’. It would be a fascinating story for the young doctor to learn about the long journey that the dedicated biomedical scientists of yesteryears took to reach the final destination of producing such wonder drugs. The story is much like an interesting novel, full of twists and turns, heart-breaking failures and glorious successes. The biologicals acting as ‘targeted therapy’ have not only changed the natural history of a large number of incurable/uncontrollable diseases but have also transformed the whole approach towards drug development. From the classical empirical process, there is now a complete shift towards understanding the disease pathobiology focusing on the dysregulated molecule(s), targeting them with greater precision and aiming for better results. Seminal advances in understanding the disease mechanism, development of remarkably effective new technologies, greater knowledge of the human genome and genetic medicine have all made it possible to reach the stage where artificially developed ‘targeted’ drugs are now therapeutically used in routine clinical medicine.

Accesibilidad y adherencia a drogas biológicas en un servicio público de reumatología de la ciudad de Rosario, Santa Fe, Argentina / Accessibility and adherence to biological drugs in a public rheumatology service in the city of Rosario, Santa Fe, Argentina

Objetivo: Describir la situación de accesibilidad y adherencia a tratamientos con drogas biológicas en pacientes de un servicio público de reumatología. Métodos: Estudio de corte transversal, observacional y retrospectivo que incluyó pacientes con gestión de DB. Variables: sociodemográficas, clínicas, tratamientos, tiempo desde el diagnóstico al acceso, adherencia (porcentaje de toma mensual y adecuada de la droga ≥75%); tiempo desde prescripción a administración; trámite administrativo realizado por entidad pública u obra social; certificado único de discapacidad (CUD). Resultados: Se incluyeron 57 pacientes, 86% mujeres, edad media 47,79 años (IC 95%: 44,46-51,12); educación media 8,42 años (IC 95%: 7,68-9,16); 82,5% nivel socioeconómico medio-bajo; 63,2% etnia mestiza; 19,3% cobertura privada. Patología más frecuente: artritis reumatoidea. Tiempo medio desde el diagnóstico a la DB: 104,25 meses (IC 95%: 82,61-125,89). Tiempo medio desde la prescripción a la aplicación: 6,4 meses (IC 95%: 5,62-7,18). Adherencia del 86,0%. 50% de los pacientes contaban con CUD. No hubo diferencias en el tiempo de espera desde prescripción a administración de DB, en relación a cobertura de salud (p=0,065) y nivel socioeconómico. Conclusión: Existe un largo tiempo de evolución de la enfermedad en relación a la accesibilidad a DB y tanto el acceso como la adherencia reflejan la vulnerabilidad de estos pacientes.

Objective: To describe the situation of accessibility and adhesion treatment of patients with biological drugs (BD) from a public rheumatology service. Methods: Cross-sectional, observational and retrospective study, which includes patients who have been treated with BD. Variables: sociodemographic; clinical and treatments; time from diagnosis to BD access, adherence (monthly intake percentage of the drug ≥75%); time from the prescription to the administration of the BD; paperwork by a public or private entity; disability certificate (DC). Results: A total of 57 patients were included, 86% women, mean age being 47.79 (95% CI: 44.46-51.12) and education years being 8.42 (95% CI: 7.68- 9.16). 82.5% belonged to a medium-low socioeconomic status and 63.2% were mestizos. 19.3% had private coverage. Rheumatoid Arthritis was the most frequent disease. The mean time from diagnosis to BD: 104.25 months (95% CI: 82.61-125.89). The mean time from prescription to application: 6.4 months (95% CI: 5.62-7.18). The adherence was 86.0% and 50.0 % of patients had DC. There were no differences in the waiting time from the prescription to BD administration, taking into account the health coverage (p = 0.065) and socioeconomic status. Conclusion: There is a long time of disease evolution in regarding the accessibility to BD. In addition, accessibility and adherence reflect the vulnerability of our patients.

Treatment interruption of biological drugs and tofacitinib in rheumatoid arthritis: A systematic review of case reports

The aim of this study was to evaluate interruption of treatment with biological drugs and tofacitinib due to adverse events in patients with rheumatoid arthritis. A systematic review was performed in the electronic databases MEDLINE, Cochrane, Scopus, CRD, IPA, Lilacs and Scielo. Case reports addressing interruption of treatment due to any adverse event related to abatacept (ABA), adalimumab (ADA), anakinra (ANA), certolizumab pegol (CER), etanercept (ETA), golimumab (GOL), infliximab (IFX), rituximab (RTX), secukinumab (SEC), tocilizumab (TCZ), tofacitinib (TOF) or ustekinumab (UST) in rheumatoid arthritis patients were evaluated. Baseline data, patient profile, previous and current treatments, cause of discontinuation and information on reintroduction of treatment were extracted from the case reports. One hundred and fifty-four studies (154 patients) reported 162 discontinuations of rheumatoid arthritis treatment due to adverse events (ETA = 57; IFX = 46; ADA = 32; TCZ = 13; RTX = 5; ANA = 3; GOL = 2; ABA = 2; TOF = 1; CER = 1; SEC = 0 and UST = 0). The mean age of patients was 56 (± 12.1) years and 82% were female. Seventy-four adverse events were confirmed (related to used drug), and 138 were observed in patients using anti-TNF. The most common adverse events were infections (21%), skin disease (15%), autoimmune disease (13%) and hematological disorders (9%). Case reports are important in the detection of rare adverse events and should be considered in the choice of appropriate therapy for patients.

Protein PEGylation for the design of biobetters: from reaction to purification processes

The covalent attachment of polyethylene glycol (PEG) to therapeutical proteins is an important route to develop biobetters for biomedical, biotech and pharmaceutical industries. PEG conjugation can shield antigenic epitopes of the protein, reduce degradation by proteolytic enzymes, enhance long-term stability and maintain or even improve pharmacokinetic and pharmacodynamics characteristics of the protein drug. Nonetheless, correct information in terms of the PEGylation process from reaction to downstream processing is of paramount importance for the industrial application and processing scale-up. In this review we present and discuss the main steps in protein PEGylation, namely: PEGylation reaction, separation of the products and final characterization of structure and activity of the resulting species. These steps are not trivial tasks, reason why bioprocessing operations based on PEGylated proteins relies on the use of analytical tools according to the specific pharmaceutical conjugate that is being developed. Therefore, the appropriate selection of the technical and analytical methods may ensure success in implementing a feasible industrial process

La inmunología molecular, las drogas biológicas y los nuevos blancos terapéuticos en las enfermedades autoinmunes reumáticas. Apuntes científicos tomados del XIX Congreso de Reumatología PANLAR

La reumatología continental se halla en una época de grandes y acelerados cambios a tono con el mundo actual, vinculados con el mejor conocimiento de los mecanismos patogénicos desde el nivel molecular, el impetuoso desarrollo de la ingeniería genética, los anticuerpos monoclonales, y desarrollo de la industria farmacéutica todo ello en consonancia con el descubrimiento de nuevos blancos terapéuticos y nuevas formas de dirigir las estrategias de diagnóstico y tratamiento para el adecuado manejo de las afecciones autoinmunes reumáticas

The continental rheumatology is in a time of great and rapid changes in tune with today's world, linked to the better understanding of the pathogenic mechanisms from the molecular level, the rapid development of genetic engineering, monoclonal antibodies, and development pharmaceutical industry all in keeping with the discovery of new therapeutics and new ways of running the diagnostic and treatment strategies for the proper management of rheumatic autoimmune conditions whites

Indústria farmacêutica: uma abordagem crítica / Pharmaceutical industry: a critical approach

JUSTIFICATIVA E OBJETIVOS: É feita uma abordagem crítica da indústria farmacêutica, no sentido de apontar o seu lado perverso.O objetivo foi analisar os ensaios clínicos e também a relação da indústria farmacêutica com os médicos e os pesquisadores. CONTEÚDO: Na área de Pesquisa & Desenvolvimento (P&D) é ressaltado que os ensaios clínicos são balizados pelos executivos dos laboratórios farmacêuticos e não pelos médicos-pesquisadores. É salientado que os custos de um novo fármaco são superestimados para justificar os preços abusivos para os usuários. A questão do marketing é analisada, com ênfase no poder de manipulação da indústria farmacêutica sobre a corporação médica e a sociedade. Na área das patentes de novos fármacos é abordada a sua longa duração e ainda que os laboratórios usam de muitos artifícios para prorrogá-las. O uso do placebo, nos ensaios clínicos, é enfocado dentro da ótica da legislação brasileira. Outras questões são levantadas, como o ingresso dos genéricos no mercado farmacêutico e a frustração da terapia gênica. CONCLUSÃO: Alguns aspectos são equacionados e algumas recomendações são feitas com o objetivo de corrigir ou minimizar as distorções apontadas.

BACKGROUND AND OBJECTIVES: A critical approach of pharmaceutical Industry is made, to show its dark side. This study intended to evaluate the clinical essays and also the relationship of pharmaceutical companies with the medical class and researchers. CONTENTS: In the area of research and development is pointed out that the clinical trials are controlled by the staff of pharmaceutical companies, not by the medical-researchers. The cost of innovation (a new drug) is overestimate to justify the overcharge to consumers. The marketing affair is analyzed and the power of manipulation of the pharmaceutical industry concerning the medical corporation and society is emphasize. The patents of new drugs have a very long duration and the companies use several artifices to extend them. The approach of placebo use in the trials is made according to Brazilian law. Other questions are analyzed as the entrance of generics in the market and the frustration of gene therapy. CONCLUSION: Some features are considered and some recommendations are made to correct or to reduce the distortions to point out.