Marina Amaral de Ávila Machado

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em acoes judiciais. METODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saude e a representacao dos autores junto ao Poder Judiciario. Os medicamentos foram descritos segundo registro na Agencia Nacional de Vigilância Sanitaria, essencialidade, inclusao programatica no Sistema Unico de Saude e evidencias de eficacia. RESULTADOS: Mais de 70% dos autores foram atendidos no sistema privado de saude e 60,3% foram representados por advogados particulares. O diagnostico mais frequente foi o de artrite reumatoide (23,1%) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5% dos medicamentos pleiteados nao eram registrados na Agencia, 19,6% estavam presentes na Relacao Nacional de Medicamentos Essenciais, 24,3% compunham o Programa de Medicamentos de Alto Custo e 53,9% apresentavam evidencia consistente de eficacia. Dentre os medicamentos nao disponiveis no sistema publico, 79,0% apresentavam alternativa terapeutica nos programas de assistencia farmaceutica. CONCLUSOES: O fenomeno da judicializacao na saude pode indicar falhas do sistema publico de saude, uma vez que ha solicitacoes de medicamentos constantes de suas listas. Todavia, constitui um obstaculo para a pratica do uso racional de medicamentos e para a consolidacao das premissas da Politica Nacional de Medicamentos, principalmente quando sao solicitados medicamentos sem comprovacao de eficacia e nao padronizados pelo Sistema Unico de Saude.OBJECTIVE To analyze the profile of claimants and medicines demanded in lawsuits. METHODS Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.

Médicos, advogados e indústria farmacêutica na judicialização da saúde em Minas Gerais, Brasil

OBJETIVO: Descrever as relacoes entre medico prescritor, advogado e industria farmaceutica em acoes judiciais contra o Estado. METODOS: Estudo descritivo retrospectivo com base nas informacoes dos expedientes administrativos dos processos judiciais com demandas por medicamentos contra o Estado de Minas Gerais movidos entre outubro de 1999 e outubro de 2009. As variaveis estudadas foram: sexo, idade e doenca dos beneficiarios das acoes, origem do atendimento medico (publico ou privado), medico prescritor, tipo de representacao juridica e medicamento solicitado. Foi realizada analise descritiva das variaveis com a distribuicao de frequencias. RESULTADOS: Foram analisadas 2.412 acoes judiciais referentes a 2.880 medicamentos solicitados, com 18 farmacos diferentes. Entre esses, 12 sao fornecidos pelas politicas de assistencia farmaceutica do Sistema Unico de Saude (SUS). Os medicamentos mais solicitados foram adalimumabe, etanercepte, infliximabe e insulina glargina. As principais doencas dos beneficiarios foram artrite reumatoide, espondilite anquilosante, diabetes mellitus e doencas pulmonares obstrutivas cronicas. Houve predominio de representacao por advogados particulares e atendimento por medicos do setor privado. Entre as acoes representadas pelo escritorio A, 43,6% tiveram um unico medico prescritor para o adalimumabe e 29 medicos foram responsaveis por 40,2% dos pedidos do mesmo farmaco. Apenas um medico foi responsavel por 16,5% das prescricoes de adalimumabe, solicitado por apenas um escritorio particular de advocacia, em 44,8% dos pedidos. CONCLUSOES: A maior representatividade de medicos do setor privado e advogados particulares pode trazer prejuizo a equidade. Os dados sugerem associacao entre medicos e escritorios de advocacia nas solicitacoes dos medicamentos. Esse quadro e um indicio de que a Justica e a medicina tem sido utilizadas para atender aos interesses da industria farmaceutica.OBJECTIVE To describe the relationship between the prescribing doctor, lawyer and pharmaceutical industry in lawsuits against the state. METHODS Retrospective descriptive study based on data from administrative files, relating to lawsuits involving medicine demands, in the state of Minas Gerais, Southeastern Brazil, from October 1999 to October 2009. RESULTS A total of 2,412 lawsuits were analyzed with 2,880 medicine requests, including 18 different drugs, 12 of them provided through Pharmaceutical Policies of the Brazilian National Health System (SUS). The most frequent medicines requested included were adalimumab, etanercept, infliximab, insulin glargine and tiotropium bromide. The main diseases were rheumatoid arthritis, ankylosing spondylitis, diabetes mellitus, and chronic obstructive pulmonary disease. Private lawyers and doctors were predominant. The results revealed the association between doctors and law offices on drug requests. Among the lawsuits filed by the office A, 43.6% had a single prescriber to adalimumab, while 29 doctors were responsible for 40.2% of the same drug prescriptions. A single doctor was responsible for 16.5% of the adalimumab prescriptions, being requested through lawsuits filed by a single private law office in 44.8% of legal proceedings. CONCLUSIONS A greater representation of doctors and lawyers from the private sector can hinder equity in health. The results revealed the association between doctors and law offices on drug requests. This is an indication that justice and medical practice have been used, at certain times, to serve the interests of the pharmaceutical industry.

Doctors, lawyers and pharmaceutical industry on health lawsuits in Minas Gerais, Southeastern Brazil

OBJETIVO: Descrever as relacoes entre medico prescritor, advogado e industria farmaceutica em acoes judiciais contra o Estado. METODOS: Estudo descritivo retrospectivo com base nas informacoes dos expedientes administrativos dos processos judiciais com demandas por medicamentos contra o Estado de Minas Gerais movidos entre outubro de 1999 e outubro de 2009. As variaveis estudadas foram: sexo, idade e doenca dos beneficiarios das acoes, origem do atendimento medico (publico ou privado), medico prescritor, tipo de representacao juridica e medicamento solicitado. Foi realizada analise descritiva das variaveis com a distribuicao de frequencias. RESULTADOS: Foram analisadas 2.412 acoes judiciais referentes a 2.880 medicamentos solicitados, com 18 farmacos diferentes. Entre esses, 12 sao fornecidos pelas politicas de assistencia farmaceutica do Sistema Unico de Saude (SUS). Os medicamentos mais solicitados foram adalimumabe, etanercepte, infliximabe e insulina glargina. As principais doencas dos beneficiarios foram artrite reumatoide, espondilite anquilosante, diabetes mellitus e doencas pulmonares obstrutivas cronicas. Houve predominio de representacao por advogados particulares e atendimento por medicos do setor privado. Entre as acoes representadas pelo escritorio A, 43,6% tiveram um unico medico prescritor para o adalimumabe e 29 medicos foram responsaveis por 40,2% dos pedidos do mesmo farmaco. Apenas um medico foi responsavel por 16,5% das prescricoes de adalimumabe, solicitado por apenas um escritorio particular de advocacia, em 44,8% dos pedidos. CONCLUSOES: A maior representatividade de medicos do setor privado e advogados particulares pode trazer prejuizo a equidade. Os dados sugerem associacao entre medicos e escritorios de advocacia nas solicitacoes dos medicamentos. Esse quadro e um indicio de que a Justica e a medicina tem sido utilizadas para atender aos interesses da industria farmaceutica.OBJECTIVE To describe the relationship between the prescribing doctor, lawyer and pharmaceutical industry in lawsuits against the state. METHODS Retrospective descriptive study based on data from administrative files, relating to lawsuits involving medicine demands, in the state of Minas Gerais, Southeastern Brazil, from October 1999 to October 2009. RESULTS A total of 2,412 lawsuits were analyzed with 2,880 medicine requests, including 18 different drugs, 12 of them provided through Pharmaceutical Policies of the Brazilian National Health System (SUS). The most frequent medicines requested included were adalimumab, etanercept, infliximab, insulin glargine and tiotropium bromide. The main diseases were rheumatoid arthritis, ankylosing spondylitis, diabetes mellitus, and chronic obstructive pulmonary disease. Private lawyers and doctors were predominant. The results revealed the association between doctors and law offices on drug requests. Among the lawsuits filed by the office A, 43.6% had a single prescriber to adalimumab, while 29 doctors were responsible for 40.2% of the same drug prescriptions. A single doctor was responsible for 16.5% of the adalimumab prescriptions, being requested through lawsuits filed by a single private law office in 44.8% of legal proceedings. CONCLUSIONS A greater representation of doctors and lawyers from the private sector can hinder equity in health. The results revealed the association between doctors and law offices on drug requests. This is an indication that justice and medical practice have been used, at certain times, to serve the interests of the pharmaceutical industry.

Adalimumab in rheumatoid arthritis treatment: a systematic review and meta-analysis of randomized clinical trials

Since the discovery of the role of tumor necrosis factor in the physiopathological process of rheumatoid arthritis, five drugs that block this cytokine have been used as therapeutic options. To evaluate the efficacy and safety of adalimumab in the treatment of rheumatoid arthritis we performed a systematic review and meta-analysis of randomized controlled trials. A search of relevant studies in Medline (through PubMed) and LILACS in June 2011 was carried out. Study selection, data collection and analysis were performed in pairs and independently by two reviewers and by a third reviewer in cases of disagreement. The meta-analysis was performed using the software Review Manager® 5.1 using the random effects model. Eleven articles related to adalimumab were included and considered nine studies with 3461 patients. Ten studies showed low risk of bias regarding the blinding of participants and personnel and blinding of outcome assessment. Patients who received the combination treatment of adalimumab and methotrexate showed better efficacy results and lower radiographic progression when compared to placebo + methotrexate in 24-104 weeks. Patients who received adalimumab as monotherapy showed better efficacy outcomes when compared to placebo in 24 and 26 weeks. The results of the meta-analyses of adverse events were not statistically significant, except for reactions at the injection site, which favored the control group. Adalimumab efficacy was demonstrated in monotherapy and when associated to a DMARD, but the evidence for combined use is more robust.

Medication Persistence of Disease‐Modifying Antirheumatic Drugs and Anti–Tumor Necrosis Factor Agents in a Cohort of Patients With Rheumatoid Arthritis in Brazil

To assess the use and persistence of anti–tumor necrosis factor (anti‐TNF) versus disease‐modifying antirheumatic drug (DMARD) therapies in patients with rheumatoid arthritis (RA) in Brazil.

Rituximab for rheumatoid arthrits treatment: a systematic review

INTRODUCTION Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic joint inflammation that often leads to significant disability. Several effective anti-TNF agents have been used, but some patients have shown an inadequate response. Rituximab is a therapeutic monoclonal antibody indicated in such cases. METHODS We conducted a systematic review to access efficacy and safety of rituximab in patients with active RA which have or have not been treated with anti-TNF agents before, and to relate outcome with RF and anti-CCP serology. We searched major electronics databases, grey literature and searched for references manually. We used Review Manager(r)5.1 for meta-analysis. RESULTS We included six RCTs comparing rituximab 1000 mg with placebo. Methotrexate was used by both groups. Treatment with rituximab was more effective in naïve and in anti-TNF treatment failure patients - ACR20/50/70 and EULAR response. We observed lower changes in Total Genant-modified Sharp score, erosion score and joint narrowing scores in the rituximab group, and SF-36, FACIT-T and HAQ-DI scores were also better in this group. There were no differences between groups regarding safety outcomes, with exception of acute injection reactions, which were more common on rituximab group. More RF/anti-CCP seropositive patients achieved ACR20 than RF/anti-CP negative patients in rituximab group. CONCLUSION Available data support the use of rituximab for the treatment of RA, as it is an effective and safe option for naïve and anti-TNF treatment failure patients. RF and anti-CCP seam to influence treatment results, but this inference needs further research.

Medication persistence of DMARDs and anti‐TNF agents in a cohort of patients with rheumatoid arthritis in Brazil

To assess the use and persistence of anti–tumor necrosis factor (anti‐TNF) versus disease‐modifying antirheumatic drug (DMARD) therapies in patients with rheumatoid arthritis (RA) in Brazil.

Infliximabe, metotrexato e sua combinação no tratamento da artrite reumatoide: revisão sistemática e metanálise

We performed a systematic review to evaluate the efficacy and safety of infliximab + methotrexate (IFX + MTX) regimens versus MTX alone or in combination with other disease-modifying anti-rheumatic drugs (DMARDs). We searched through major databases, the grey literature and did a manual search. Two independent reviewers conducted the selection, data extraction and analysis of the quality of the studies. Meta-analysis was conducted using Review Manager(®) 5.1 software. Nine trials were included. The mean modified Jadad score was 4.4, but only one study showed low risk of bias. IFX + MTX regimen presented better responses in clinical outcomes of ACR and DAS28 by up to 54 weeks, and of radiographic progression by up to 104 weeks. Withdrawals due to lack of efficacy was lower in the IFX + MTX group. No significant difference in adverse events was observed. The IFX + MTX combination is more effective than treatment with MTX alone or DMARDs combination. This regimen presented good tolerability in patients previously treated with DMARDs, not treated with MTX or with insufficient responses to MTX. The efficacy of IFX + MTX is noted primarily during initial periods of treatment. High doses of IFX were as effective as the standard dose, but with possible higher risk of serious infections. Therefore, we advise clinicians to use the standard dose of IFX 3 mg/kg every 8 weeks.

Médicos, abogados e industria farmacéutica en la judicialización de la salud en Minas Gerais, Sudeste de Brasil

OBJETIVO: Descrever as relacoes entre medico prescritor, advogado e industria farmaceutica em acoes judiciais contra o Estado. METODOS: Estudo descritivo retrospectivo com base nas informacoes dos expedientes administrativos dos processos judiciais com demandas por medicamentos contra o Estado de Minas Gerais movidos entre outubro de 1999 e outubro de 2009. As variaveis estudadas foram: sexo, idade e doenca dos beneficiarios das acoes, origem do atendimento medico (publico ou privado), medico prescritor, tipo de representacao juridica e medicamento solicitado. Foi realizada analise descritiva das variaveis com a distribuicao de frequencias. RESULTADOS: Foram analisadas 2.412 acoes judiciais referentes a 2.880 medicamentos solicitados, com 18 farmacos diferentes. Entre esses, 12 sao fornecidos pelas politicas de assistencia farmaceutica do Sistema Unico de Saude (SUS). Os medicamentos mais solicitados foram adalimumabe, etanercepte, infliximabe e insulina glargina. As principais doencas dos beneficiarios foram artrite reumatoide, espondilite anquilosante, diabetes mellitus e doencas pulmonares obstrutivas cronicas. Houve predominio de representacao por advogados particulares e atendimento por medicos do setor privado. Entre as acoes representadas pelo escritorio A, 43,6% tiveram um unico medico prescritor para o adalimumabe e 29 medicos foram responsaveis por 40,2% dos pedidos do mesmo farmaco. Apenas um medico foi responsavel por 16,5% das prescricoes de adalimumabe, solicitado por apenas um escritorio particular de advocacia, em 44,8% dos pedidos. CONCLUSOES: A maior representatividade de medicos do setor privado e advogados particulares pode trazer prejuizo a equidade. Os dados sugerem associacao entre medicos e escritorios de advocacia nas solicitacoes dos medicamentos. Esse quadro e um indicio de que a Justica e a medicina tem sido utilizadas para atender aos interesses da industria farmaceutica.OBJECTIVE To describe the relationship between the prescribing doctor, lawyer and pharmaceutical industry in lawsuits against the state. METHODS Retrospective descriptive study based on data from administrative files, relating to lawsuits involving medicine demands, in the state of Minas Gerais, Southeastern Brazil, from October 1999 to October 2009. RESULTS A total of 2,412 lawsuits were analyzed with 2,880 medicine requests, including 18 different drugs, 12 of them provided through Pharmaceutical Policies of the Brazilian National Health System (SUS). The most frequent medicines requested included were adalimumab, etanercept, infliximab, insulin glargine and tiotropium bromide. The main diseases were rheumatoid arthritis, ankylosing spondylitis, diabetes mellitus, and chronic obstructive pulmonary disease. Private lawyers and doctors were predominant. The results revealed the association between doctors and law offices on drug requests. Among the lawsuits filed by the office A, 43.6% had a single prescriber to adalimumab, while 29 doctors were responsible for 40.2% of the same drug prescriptions. A single doctor was responsible for 16.5% of the adalimumab prescriptions, being requested through lawsuits filed by a single private law office in 44.8% of legal proceedings. CONCLUSIONS A greater representation of doctors and lawyers from the private sector can hinder equity in health. The results revealed the association between doctors and law offices on drug requests. This is an indication that justice and medical practice have been used, at certain times, to serve the interests of the pharmaceutical industry.

Judicialización del acceso a medicamentos en el Estado de Minas Gerais, Sureste de Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em acoes judiciais. METODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saude e a representacao dos autores junto ao Poder Judiciario. Os medicamentos foram descritos segundo registro na Agencia Nacional de Vigilância Sanitaria, essencialidade, inclusao programatica no Sistema Unico de Saude e evidencias de eficacia. RESULTADOS: Mais de 70% dos autores foram atendidos no sistema privado de saude e 60,3% foram representados por advogados particulares. O diagnostico mais frequente foi o de artrite reumatoide (23,1%) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5% dos medicamentos pleiteados nao eram registrados na Agencia, 19,6% estavam presentes na Relacao Nacional de Medicamentos Essenciais, 24,3% compunham o Programa de Medicamentos de Alto Custo e 53,9% apresentavam evidencia consistente de eficacia. Dentre os medicamentos nao disponiveis no sistema publico, 79,0% apresentavam alternativa terapeutica nos programas de assistencia farmaceutica. CONCLUSOES: O fenomeno da judicializacao na saude pode indicar falhas do sistema publico de saude, uma vez que ha solicitacoes de medicamentos constantes de suas listas. Todavia, constitui um obstaculo para a pratica do uso racional de medicamentos e para a consolidacao das premissas da Politica Nacional de Medicamentos, principalmente quando sao solicitados medicamentos sem comprovacao de eficacia e nao padronizados pelo Sistema Unico de Saude.OBJECTIVE To analyze the profile of claimants and medicines demanded in lawsuits. METHODS Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.