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

MÉTODOS: Estudo descritivo retrospectivo com base nas informações 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 variáveis estudadas foram: sexo, idade e doença dos benefi ciários das ações, origem do atendimento médico (público ou privado), médico prescritor, tipo de representação jurídica e medicamento solicitado. Foi realizada análise descritiva das variáveis com a distribuição de frequências.


INTRODUCTION
New medicines are often launched on the market at higher prices than existing ones without adding any therapeutic benefi ts to patients.According to Vidotti et al 12 (2008), of the 109 medicines registered in the National Health Surveillance Agency (ANVISA) in Brazil, between 2000 and 2004, approximately 40% showed no innovation in relation to the previously available drugs, according to classifi cation by the Food and Drug Administration (FDA).None were included in the National List of Essential Medicines (Rename); therefore, they did not meet the most important health needs of the population, as defi ned by the World Health Organization (WHO).a The high costs of new drugs impact the Pharmaceutical Assistance (AF) program of the Brazilian National Health System (SUS), as the lawsuits fi led by the patients lead to the free supply of these drugs under the claim of constitutional right to health.The Judiciary contributes to the introduction to the market of medicines not previously standardized by the SUS or belonging to the Specialized Component Pharmaceutical Assistance program (high-cost drugs) for health conditions not governed by guidelines or protocols.On the other hand, requests related to medicaments belonging to other AF/ SUS programs are motivated by supply-line problems, such as insuffi cient quantity procurement or failure to meet delivery schedule. 5,7,9,10,14udies carried out in São Paulo and Minas Gerais in 2006 showed a high number of judicial claims requesting adalimumab and etanercept (then not yet incorporated into the SUS list) from a small group of prescribers and lawyers.Such results suggest inappropriate relationships between these professionals and the pharmaceutical companies, mischaracterizing the guarantee to the right to health as the overriding motivation in these lawsuits. 6e present study aims to describe the relationship between prescribers, lawyers and the pharmaceutical industry in lawsuits against the state.

METHODS
A retrospective descriptive study was carried out based on data contained in administrative fi les relating to legal proceedings involving medicament demands in Minas Gerais, fi led between October 1999 and October 2009.
Data were collected at the Minas Gerais State Health Secretary (SES-MG) between February and November 2009 by the Health Economics Research Group (GPES/ UFMG).A pre-tested form was applied to the administrative fi les of completed or ongoing legal proceedings.The information obtained was stored in a database using Microsoft ® Offi ce Access 2007.prosecutor, public defender), care (prescriber, medical specialty, type of healthcare provided, healthcare center, diagnosis according to the International Classifi cation of Diseases − ICD-10), medicament (as classifi ed by the Anatomical Therapeutic Chemical Code − ATC) and pharmaceutical company.The benefi ciary's age was calculated based on the initial petition and birth dates.
From the 6,112 fi led lawsuits, those requesting medicines containing drugs included in more than 100 cases were selected, which represented 18 items (47.1% of cases).These drugs were described according to chemical substance (ATC level 5) and grouped into their various presentations.However, only individual cases were considered, i.e., those representing a single applicant and involving a single law offi ce, prescriber and medicament request, as it was not possible to establish a relation between a specifi c medicine/disease and an individual patient in collective lawsuits.Therefore, medicines whose drugs were requested in less than 100 lawsuits were included in the analysis.
The relationships between doctors, lawyers and the pharmaceutical industry were established by crossing between "name of the doctor," "law offi ce", "active ingredient" and "pharmaceutical company".In the analysis, the following were considered as law offi ces: federal and state public defenders, municipal legal assistance services, legal assistance centers at law faculties and private law offi ces.These differences are pointed out in the results.Medical specialties and type of healthcare provider (SUS or the private sector) were also associated with the doctors and identifi ed from the prescription recorded in the database.
The descriptive data analysis was conducted with the table presentation of the frequency distribution (relative and absolute) of selected variables.In addition to Microsoft Offi ce Excel ® 2007, the MySQL 5.1.41software program was used to manage the database.
The ethical aspects and confi dentiality of the study were guaranteed.This study is part of the project "Impact of lawsuits on the national policy of pharmaceutical assistance: clinical management and medicalization of justice", from Universidade de Minas Gerais, b with the approval of the Research Ethics Committee of the university (COEP) (Resolution No. ETIC 292/08).

RESULTS
The 6,112 lawsuits covered 10,078 medicament requests, including 802 different drugs.By applying the selection criteria, 2,412 lawsuits were analyzed, totaling 2,880 medicaments which included 18 different pharmacological agents.
Most plaintiffs were female, with a slight predominance of over 40-year-olds (Table 1).
The most common diseases and medications included rheumatoid arthritis and ankylosing spondylitis (adalimumab, etanercept and infl iximab), diabetes mellitus (insulin glargine) and other chronic obstructive pulmonary diseases (tiotropium bromide) (Tables 1 and 2).
Private lawyers and doctors from the private healthcare system were predominant (Table 1).However, there were also requests from the Public Defender's Offi ce of Minas Gerais (DPMG) for the 18 medicaments studied here.In actions involving four of these drugs (tiotropium bromide, clopidogrel, losartan and simvastatin), the largest legal representation was made by the DPMG.There were 152 lawsuits fi led by the DPMG for these four drugs, equivalent to 33.6% of the DPMG lawsuits and 6.3% of the total selected in this study (Table 2).
There was a concentration of the same doctors and lawyers in the applications of the most demanded drugs (Table 2).
The four legal representatives responsible for the largest number of lawsuits brought 687 actions (61.8%):DPMG with 359; offi ce A, 165; offi ce B, 87; offi ce C, 76.There was a concentration of requests for one or two drugs by the three law offi ces.Offi ce A had 160 requests for adalimumab; offi ce B, 59 for etanercept; and offi ce C, 28 for adalimumab and 36 for etanercept.The three doctors with the highest number of prescriptions were linked to 126 applications (10.9%): doctor X was responsible for 76; doctor Y, 25; and doctor Z, 25.Regarding the results related to the law offi ces, the most common medicaments were adalimumab and etanercept.Doctor X issued 59 prescriptions for adalimumab and 17 for etanercept; doctor Y, 21 and 2, respectively; and doctor Z, 9 and 15, respectively.The three doctors were rheumatologists, worked in the private sector and the medicaments were prescribed to treat rheumatoid arthritis.
A relationship between the doctors and the law offi ces was observed in the requests for medicaments Among the lawsuits represented by offi ce A, 43.6% had doctor X as the prescriber to adalimumab (Abbott), and 29 doctors were responsible for 40.2% of the requests for this drug.Doctor X was also the main prescriber in the lawsuits involving etanercept, which were fi led by offi ces B and C. At offi ce B, doctor X was involved in 9.0% of the lawsuits, and at offi ce C, in 12.3%.At the time of the study, it had been standardized only in Minas Gerais.Some drugs were not standardized at the time of the lawsuits, which led to judicialization.Some drugs included on offi cial lists at the time of the lawsuits had their availability restricted as a result of failures in the Pharmaceutical Assistance program due to shortages or logistical problems, which led to legal aid.

DISCUSSION
Benefi ciaries in the 0-19 and 40-59 age groups were the majority.Type 1 diabetes can be predominantly associated with the fi rst age group, while rheumatoid arthritis and obstructive pulmonary diseases are more linked to the second group 3 .Information regarding to age has considerable limitations, because the birth date or the date of the application were not reported in 61.5% of cases.
A relation between the most requested medicaments with the diagnoses and the key medical specialties was observed in the lawsuits.This shows prescription consistency, not necessarily rationality, because many drugs are not the fi rst line of treatment, such as monoclonal antibodies (adalimumab and etanercept) for rheumatoid arthritis.c Currently, there are fi ve classes of drugs: analgesics, nonsteroidal anti-infl ammatory drugs (NSAIDs), corticosteroids, disease-modifying drugs and anti-citokyne agents, called monoclonal antibodies.These drug classes are available through the SUS, either by the municipal or state entity.Not using a protocol-defi ned therapeutic sequence can be considered as irrational, in pharmacological and economic terms, as adalimumab and etanercept are expensive drugs.But the therapy may vary according to patient characteristics and response to previous treatment regimes.Thus, where using the fi rst or second-line treatment was not possible, after the available pharmacological alternatives were tested, the use of monoclonal antibodies could be advised.
Messeder et al 9 (2005) showed that there was an increase in the request of mesalazine, riluzole, peginterferon, sevelamer, levodopa + benserazide, rivastigmine, simvastatin and infl iximab in the State of Rio de Janeiro, in 2001.These drugs were added to the Exceptional Dispensation Medicaments Program (current Specialized Component list of the Pharmaceutical Assistance) at the end of 2002.
Similarly, the increase in the number of lawsuits for adalimumab in Minas Gerais can be observed, especially in 2006, when it was incorporated into the Exceptional Dispensation Medicaments Program.The increase in demand for these new drugs may refl ect the performance of the pharmaceutical industry towards including their products in the SUS list.On the other hand, it may be the answer to an unmet demand for healthcare.
Private lawyers prevailed in lawsuits fi led in Minas Gerais, a situation observed in different parts of the cuntry. 5,8,10,13d A low frequency of legal proceedings fi led by free legal assistance centers linked to law faculties was observed.This trend, also observed in other studies, indicates that people with lower income have not often accessed the courts to receive medicaments This is probably due to the low supply of this type of assistance, which also happens in the Public Defender's Offi ces.
10] The lawsuits represent a diversion of substantial resources for the fulfi llment of court injunctions, to the detriment of other actions and health services that the state provides.Information released by the Minas Gerais State Health Secretary (SES-MG) shows an unusual increase of more than 28,333% in spending on medicament lawsuits from 2002 (R$ 164,325.00) to June 2011 (R$ 46,362,563.00).
To readjust the budget with this new situation, other public health projects are postponed. 1small number of lawyers and doctors were associated with numerous lawsuits, as seen most notably but not exclusively, in relation to adalimumab in Minas Gerais.
Chieffi & Barata 6 (2010) showed that 1 % of lawyers represented 35 % of the lawsuits in São Paulo, a single doctor prescribed erlotinib in 66% of lawsuits related to this medicament and a single lawyer fi led 82 % of the lawsuits requesting bevacizumab .
The results suggest a relationship between law offi ce A and doctor X, which may indicate a "partnership" between these professionals and the pharmaceutical company that produces adalimumab.A single doctor linked to offi ce A was responsible for approximately 44% of prescriptions in 117 lawsuits; 34 doctors were related to the rest of the legal proceedings.No clear relationship was identifi ed between these actors and offi ces B and C, since the medicament requests were distributed by a larger number of doctors.These results corroborate Chieffi & Barata 6 (2010), who reported a higher number of doctors and lawyers in the judicialization of new and more expensive drugs (Table 2).
When implementing the Policy of Pharmaceutical Assistance, it is necessary to discuss if other interests than those of the population, who need and are entitled to a pharmaceutical service of high quality, permeates the relationship between the pharmaceutical industry and the health professionals, whose actions should be guided by ethics and the pursuit of the patients wellbeing.These hidden interests are denounced in the literature, and are related to the commercialization of high-cost medicaments inaccessible to a signifi cant proportion of the population. 2,6,8Carvalho 4 (2005) pointed out that the court is one of the new routes discovered by the industry for these professionals to act on its behalf, with the argument of defending the universal right to health, and the right to new medicines and medical procedures.New technologies are often consumed by the pressure of the constitutional law and emotional appeal to the Judicial System.
This study is limited by obtaining incomplete or inconsistent data from a secondary administrative source, whose original purpose is not research.This may affect the extrapolation of information.
However, despite this analysis on the relationship between doctors, lawyers and medicament supply not Twelve of the drugs included in the lawsuits are provided by the SUS Pharmaceutical Assistance program, including insulin glargine and sildenafi l 20 mg, standardized in Minas Gerais for type I diabetes mellitus and pulmonary arterial hypertension in 2005 and 2009, respectively.Sildenafi l is part of the Specialized Component list of the Pharmaceutical Assistance program since March 2010.
Project developed by Grupo de Pesquisa em Economia da Saúde from Faculdade de Medicina in Universidade de Minas Gerais and supported by Conselho Nacional de Desenvolvimento Científi co e Tecnológico (CNPq).

Table 1 .
Benefi ciary frequency distribution according to the variables of the legal proceeding database.Minas Gerais, Southeastern Brazil, from 1999 to 2009.

Table 2 .
Medicaments, doctors, law offi ces and the respective maximum number of lawsuits.a Minas Gerais, Southeastern Brazil, from 1999 to 2009.