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  <front>
    <journal-meta>
      <journal-id journal-id-type="nlm-ta">Arq Bras Cardiol</journal-id>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id specific-use="scielo-v3" pub-id-type="publisher-id">Cw85KPLHDRyDgxZh3dgQ4Mx</article-id>
      <article-id specific-use="scielo-v2" pub-id-type="publisher-id">S0066-782X2020001300807</article-id>
      <article-id pub-id-type="publisher-id">abc.20200104</article-id>
      <article-id pub-id-type="doi">10.36660/abc.20200104</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Editorial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Reflex&#227;o sobre Conflitos de Interesses em Diretrizes M&#233;dicas</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <contrib-id contrib-id-type="orcid">0000-0003-3400-0626</contrib-id>
          <name>
            <surname>Grinberg</surname>
            <given-names>Max</given-names>
          </name>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
          <xref ref-type="corresp" rid="c1"/>
        </contrib>
        <aff id="aff1">
          <label>1</label>
          <institution content-type="orgname">Instituto do Cora&#231;&#227;o</institution>
          <addr-line>
            <named-content content-type="city">S&#227;o Paulo</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brasil</country>
          <institution content-type="original">Instituto do Cora&#231;&#227;o (Incor), S&#227;o Paulo, SP &#8211; Brasil</institution>
        </aff>
      </contrib-group>
      <author-notes>
        <corresp id="c1"><bold>Correspond&#234;ncia: Max Grinberg</bold> &#8226; Rua Manoel Antonio Pinto, 4 AP 21 A. CEP <postal-code>05663-020</postal-code>, S&#227;o Paulo, SP - Brasil. E-mail: <email>grinberg@incor.usp.br</email> </corresp>
      </author-notes>
      <pub-date date-type="pub" publication-format="electronic">
        <day>07</day>
        <month>12</month>
        <year>2020</year>
      </pub-date>
      <pub-date date-type="collection" publication-format="electronic">
        <month>11</month>
        <year>2020</year>
      </pub-date>
      <volume>115</volume>
      <issue>5</issue>
      <fpage>807</fpage>
      <lpage>808</lpage>
      <permissions>
        <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/" xml:lang="en">
          <license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License</license-p>
        </license>
      </permissions>
      <kwd-group xml:lang="pt">
        <title>Palavras-chave</title>
        <kwd>Medicina</kwd>
        <kwd>Profissionalismo</kwd>
        <kwd>Diretrizes Cl&#237;nicas</kwd>
        <kwd>Conflito de Interesses</kwd>
        <kwd>Fidelidade a Diretrizes</kwd>
        <kwd>Bio&#233;tica</kwd>
      </kwd-group>
      <counts>
        <fig-count count="0"/>
        <table-count count="0"/>
        <equation-count count="0"/>
        <ref-count count="4"/>
        <page-count count="2"/>
      </counts>
    </article-meta>
  </front>
  <body>
    <p>A prescri&#231;&#227;o de um f&#225;rmaco diretamente ao paciente, a capta&#231;&#227;o do volunt&#225;rio para uma pesquisa cl&#237;nica, a palestra em um congresso da especialidade, a participa&#231;&#227;o em um comit&#234; elaborador de uma diretriz cl&#237;nica, a supervis&#227;o em uma visita cl&#237;nica com residentes, a opini&#227;o para os colegas em um cafezinho. Todas essas situa&#231;&#245;es se caracterizam como intera&#231;&#227;o humana, maior ou menor assimetria de conhecimento e influ&#234;ncia de m&#250;ltiplos interesses, em que o eventual privil&#233;gio de um pode provocar preju&#237;zo de algum outro.</p>
    <p>Dessa maneira, estabelece-se a potencialidade do confronto entre interesses,<xref ref-type="bibr" rid="B1"><sup>1</sup></xref><sup>,</sup><xref ref-type="bibr" rid="B2"><sup>2</sup></xref> o que recebe a denomina&#231;&#227;o de <italic>potencial conflito de interesses</italic>. O uso do termo &#8220;potencial&#8221; j&#225; traz a inquietude de uma possibilidade da condi&#231;&#227;o humana que, contudo, n&#227;o ocorreu, podendo nunca acontecer ou se materializar em uma recep&#231;&#227;o impercept&#237;vel ou emiss&#227;o inconsciente.</p>
    <p>A areia movedi&#231;a est&#225; na pr&#243;pria ess&#234;ncia da medicina, a necessidade de realizar um profissionalismo sob moldura &#233;tica, moral e legal. Isso demanda desdobramentos cl&#237;nicos, t&#233;cnicos, cient&#237;ficos e atitudinais sob forte indetermina&#231;&#227;o acerca da benefic&#234;ncia (conceitual) e do benef&#237;cio (individual), da n&#227;o malefic&#234;ncia (conceitual) e do n&#227;o malef&#237;cio (individual).</p>
    <p>As diretrizes cl&#237;nicas s&#227;o ilustrativas do tema-dilema. Elas ganharam o <italic>status</italic> de recomenda&#231;&#227;o de primeira ordem; assim, a confiabilidade &#233; avalizada por sociedades de especialidade id&#244;neas e servem de ponto de refer&#234;ncia para cr&#237;ticas &#233;ticas. Se, por um lado, as diretrizes cl&#237;nicas visam &#224; excel&#234;ncia est&#233;tica do T (s&#237;mbolo da abrang&#234;ncia do saber na barra horizontal e da profundidade na barra vertical) em uma proporcionalidade atualizada de acordo com evid&#234;ncias de pesquisas cl&#237;nicas, por outro lado, viv&#234;ncias profissionais e opini&#245;es de peso, o cotidiano na beira do leito, destaca a sabedoria dos ajustes individualizados. Assim, a mat&#233;ria-prima do pavio do potencial conflito de interesses &#233; a evid&#234;ncia cient&#237;fica, mas quem costuma riscar o f&#243;sforo &#233; a individualiza&#231;&#227;o.</p>
    <p>Sobressai na elabora&#231;&#227;o das diretrizes cl&#237;nicas a sele&#231;&#227;o colegiada da dimens&#227;o de efeito e da probabilidade de realiza&#231;&#227;o de m&#233;todos em doen&#231;as e circunst&#226;ncias. Os membros do comit&#234; de elabora&#231;&#227;o precisam analisar as evid&#234;ncias de determina&#231;&#245;es rec&#237;procas entre m&#233;todo e situa&#231;&#227;o cl&#237;nica.</p>
    <p>Inclus&#245;es, exclus&#245;es e classifica&#231;&#245;es prescritivas devem ser guiadas pela ideia da reciprocidade entre sal e &#225;gua, ou seja, em qualquer local, a &#225;gua dissolve o sal e o sal dissolve-se na &#225;gua, desde que l&#237;quida, n&#227;o cabendo a regra para gelo ou vapor d'&#225;gua. Ao mesmo tempo, deve-se ter em mente que cada m&#233;todo diagn&#243;stico, terap&#234;utico ou preventivo representa, invariavelmente, um bast&#227;o, em que uma extremidade carrega benefic&#234;ncia e a outra, malefic&#234;ncia. Portanto, n&#227;o existe iatrogenia zero para o paciente, as bulas assim ensinam.</p>
    <p>Ser&#225; que a manifesta&#231;&#227;o de um conflito de interesses por parte do membro do comit&#234; de elabora&#231;&#227;o de diretriz constitui desej&#225;vel vacina moral? Creio que n&#227;o. Uma coisa &#233; a plateia calibrar os poros do seu filtro cr&#237;tico sobre o que o palestrante afirma, outra coisa s&#227;o as bases para o leitor de diretrizes cl&#237;nicas supor vieses.</p>
    <p>Do ponto de vista pragm&#225;tico, n&#227;o se pode ignorar que os crit&#233;rios de qualifica&#231;&#227;o da escolha dos especialistas para elaborar uma diretriz superp&#245;em-se aos utilizados pela ind&#250;stria para a ela se associar de alguma maneira. A liga&#231;&#227;o acad&#234;mica, a produ&#231;&#227;o cient&#237;fica continuada, o cr&#233;dito entre os colegas s&#227;o ess&#234;ncias comuns. Em decorr&#234;ncia disso, &#233; alta a chance de se pensar em um nome e colidir com algum potencial conflito de interesses. Posi&#231;&#245;es radicais podem comprometer a sele&#231;&#227;o, algo como afunilar na dire&#231;&#227;o dos mais inexperientes.</p>
    <p>A bio&#233;tica da beira do leito entende que a manifesta&#231;&#227;o de um conflito de interesses no corpo de uma diretriz tem o &#250;nico objetivo de afirmar: <italic>dou a minha palavra de honra que tenho tais potenciais te&#243;ricos, mas n&#227;o os realizei</italic>.</p>
    <p>&#201; de se supor que coadores de responsabilidade da Sociedade Brasileira de Cardiologia precederam a leitura de uma nova diretriz cl&#237;nica nos Arquivos Brasileiros de Cardiologia, tais como a decis&#227;o sobre a necessidade de atualiza&#231;&#227;o/primeira vez, a sele&#231;&#227;o de nomes, a cr&#237;tica do elaborado e a aprova&#231;&#227;o final. Por isso, o foco de confian&#231;a e a responsabilidade concentram-se na gest&#227;o societ&#225;ria.</p>
    <p>As inquietudes da gest&#227;o podem ser simplificadas na tr&#237;ade: n&#227;o informa&#231;&#227;o, informa&#231;&#227;o enviesada e informa&#231;&#227;o qualificada. A complexidade &#233; que qualquer um desses pode ser objeto do conflito de interesses. Assim, escamotear uma novidade, for&#231;ar uma recomenda&#231;&#227;o ou dar &#234;nfase a uma evid&#234;ncia de fato endoss&#225;vel podem embutir interesses pessoais ou de indiv&#237;duos ligados.</p>
    <p>A bio&#233;tica da beira do leito prefere o foco na fidelidade &#224; pr&#243;pria consci&#234;ncia no desempenho de fun&#231;&#245;es sujeitas a imperfei&#231;&#245;es da condi&#231;&#227;o humana.<xref ref-type="bibr" rid="B3"><sup>3</sup></xref> Evidentemente, fortes associa&#231;&#245;es &#224; ind&#250;stria devem ser evitadas, dentro do conselho de que n&#227;o basta ser honesto, &#233; preciso evitar as d&#250;vidas.</p>
    <p>N&#227;o obstante, &#233; capital considerar que o comportamento dos membros do comit&#234; de elabora&#231;&#227;o de diretrizes ser&#225; invariavelmente de responsabilidade para com a fun&#231;&#227;o em grupo, de interesse priorit&#225;rio em prol do coletivo, de rejei&#231;&#227;o a qualquer express&#227;o de aut&#244;mato dentro do grupo, de respeito com cr&#237;tica pelo coordenador-l&#237;der, de compasso entre as conclus&#245;es de pesquisas e as realidades da beira do leito; enfim, de liberdade e de independ&#234;ncia bem sustentadas pela plataforma cient&#237;fica atualizada e validada.</p>
    <p>Algu&#233;m pode conjecturar que seria ing&#234;nuo confiar no imperativo da consci&#234;ncia,<xref ref-type="bibr" rid="B4"><sup>4</sup></xref> que mesmo um especialista, um professor-doutor, qualquer jurado por Hip&#243;crates e com um compromisso com a sociedade pela posse de um n&#250;mero de CRM, n&#227;o pode deixar de ser arrastado pela superficialidade de um interesse esp&#250;rio quando dele &#233; exigida a profundidade do seu saber e sabedoria. &#201; contraponto v&#225;lido; por&#233;m (sempre tem um por&#233;m), quem pode negar que a manifesta&#231;&#227;o do conflito de interesses, n&#227;o somente impossibilita definir os descontos necess&#225;rios na recep&#231;&#227;o, como tamb&#233;m n&#227;o funciona como um &#8220;007&#8221; moral &#8211; licen&#231;a para conflitar. H&#225; suposi&#231;&#245;es sobre um exagero estrat&#233;gico, uma tend&#234;ncia ao emissor prover mais vieses para contrabalan&#231;ar os descontos de recep&#231;&#227;o provocados pela manifesta&#231;&#227;o dos conflitos de interesses. Por outro lado, pode inibir contraposi&#231;&#245;es temendo enquadramento em realiza&#231;&#227;o de conflito de interesse.</p>
    <p>H&#225; 26 s&#233;culos, Eubulides de Mileto fez a pergunta: <italic>&#8220;Em que momento um monte de areia deixa de s&#234;-lo quando se vai removendo gr&#227;os, ou um gr&#227;o se torna um monte pelo acr&#233;scimo sucessivo?&#8221;</italic> S&#243; haver&#225; resposta de modo autorit&#225;rio, se algu&#233;m estabelecesse um crit&#233;rio com algum tipo de for&#231;a impositiva. Quanto de flexibilidade pode ser toler&#225;vel na opini&#227;o de um membro de comit&#234; de diretrizes?</p>
    <p>Dada a presun&#231;&#227;o de honestidade profissional dos s&#243;cios, que deve vigorar em uma sociedade de especialidade e a dificuldade de percep&#231;&#227;o de realiza&#231;&#245;es de conflito de interesses em uma medicina contempor&#226;nea plena de indetermina&#231;&#245;es e de metamorfoses aceleradas, creio que o potencial conflito de interesses &#233; parte indissoci&#225;vel da elabora&#231;&#227;o de qualquer diretriz cl&#237;nica, que &#233; imposs&#237;vel qualquer tipo de certeza de aus&#234;ncia da realiza&#231;&#227;o. Por isso, uma diretriz n&#227;o &#233; uma algema, mas uma b&#250;ssola. Assim, ajustes individuais s&#227;o bem-vindos.</p>
    <p>Por isso, independentemente da manifesta&#231;&#227;o dos interesses de cada membro do comit&#234; de elabora&#231;&#227;o das diretrizes pertinentes ao documento, proponho uma manifesta&#231;&#227;o ao in&#237;cio de cada diretriz: <italic>A Sociedade Brasileira de Cardiologia, desde a decis&#227;o da elabora&#231;&#227;o at&#233; a autoriza&#231;&#227;o de publica&#231;&#227;o, manteve inabalada a confian&#231;a na boa-f&#233; dos participantes, a virtude que faz da verdade cient&#237;fica um valor para a condu&#231;&#227;o das rela&#231;&#245;es consigo mesmo e com os colegas e pacientes.</italic></p>
  </body>
  <back>
    <ref-list>
      <title>Refer&#234;ncias</title>
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          </person-group>
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            </name>
          </person-group>
          <article-title>Conscience, conscientious objections, and medicine</article-title>
          <source>Theor Med Bioeth</source>
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  </back>
  <sub-article article-type="translation" id="S01" xml:lang="en">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Editorial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>A Reflection on Conflicts of Interest in Medical Guidelines</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <contrib-id contrib-id-type="orcid">0000-0003-3400-0626</contrib-id>
          <name>
            <surname>Grinberg</surname>
            <given-names>Max</given-names>
          </name>
          <xref ref-type="aff" rid="aff2">
            <sup>1</sup>
          </xref>
          <xref ref-type="corresp" rid="c2"/>
        </contrib>
        <aff id="aff2">
          <label>1</label>
          <addr-line>
            <named-content content-type="city">S&#227;o Paulo</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brazil</country>
          <institution content-type="original">Instituto do Cora&#231;&#227;o (Incor), S&#227;o Paulo, SP &#8211; Brazil</institution>
        </aff>
      </contrib-group>
      <author-notes>
        <corresp id="c2"><bold>Mailing Address: Max Grinberg &#8226;</bold> Rua Manoel Antonio Pinto, 4 AP 21 A. Postal Code <postal-code>05663-020</postal-code>, S&#227;o Paulo, SP - Brazil. E-mail: <email>grinberg@incor.usp.br</email> </corresp>
      </author-notes>
      <kwd-group xml:lang="en">
        <title>Keywords</title>
        <kwd>Medicine</kwd>
        <kwd>Professionalism</kwd>
        <kwd>Guidelines, Clinics</kwd>
        <kwd>Conflict of Interest</kwd>
        <kwd>Guideline Adherence</kwd>
        <kwd>Bioethics</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <p>Prescribing a drug directly to the patient, recruiting a volunteer for a clinical research, lecturing at a specialty congress, participating in a committee that elaborates clinical guidelines, supervising a clinical visit with residents, giving your opinion for colleagues over coffee.</p>
      <p>All of these situations are characterized by human interaction, greater or lesser asymmetry of knowledge, and multiple interests, where the possible privilege of one may cause damage to another.</p>
      <p>Thereby, the potential for confrontation between interests is established,<xref ref-type="bibr" rid="B1"><sup>1</sup></xref><sup>,</sup><xref ref-type="bibr" rid="B2"><sup>2</sup></xref> and this is called a potential conflict of interest. The use of the term &#8220;potential&#8221; brings about a possibility of the human condition that did not occur, and may never happen or materialize as an imperceptible reception or unconscious emission.</p>
      <p>Quicksand is in the very essence of medicine: the need of professionalism under an ethical, moral and legal framework that demands clinical, technical, scientific and attitudinal actions under a strong irresolution about beneficence (conceptual) and benefit (individual), of (conceptual) (non-) maleficence and (individual) (non-) harm.</p>
      <p>Clinical guidelines illustrate well the dilemma. They have gained first-rate recommendation status; their reliability is guaranteed by trustworthy specialist societies and serve as a reference for ethical criticism.</p>
      <p>If, on the one hand, clinical guidelines aim at the esthetic excellence of the letter T&#8212;symbolyzing the comprehensiveness of knowledge in the horizontal bar and its depth in the vertical bar&#8212;in a proportion that follows evidence from clinical research, professional experiences and strong opinions, on the other hand, the bedside routine highlights the wisdom of individualized adjustments. The raw material for a potential conflict of interest is scientific evidence, but it is individualization that usually lights the match.</p>
      <p>The collegiate selection of the effect dimension and the probability of carrying out methods in diseases and circumstances stand out in the creation of clinical guidelines. The steering committee members need to analyze evidence of reciprocal determinations between method and clinical settings.</p>
      <p>Inclusions, exclusions and prescriptive classifications must be guided by the idea of reciprocity of salt and water, that is: no matter the conditions, water dissolves salt and salt dissolves in water&#8212;as long as in liquid state, not fitting for ice or water vapor. At the same time, it must be borne in mind that each diagnostic, therapeutic or preventive method invariably represents a stick that carries benefit in one end and harm on the other; there is no zero iatrogenesis for the patient, as the medicines' leaflets teach us.</p>
      <p>Does the manifestation of a conflict of interest on the part of a member of a guideline committee constitute a desirable moral vaccine? I do not think so. The audience calibrating the pores of its critical filter on what the speaker says is one thing; the foundation for the reader of clinical guidelines to assume bias is another.</p>
      <p>From a pragmatic point of view, one cannot ignore that the qualification criteria for the choice of specialists to develop a guideline overlap with those used by the industry to associate itself with it in some way. Academic liaison, continued scientific production, credit among colleagues are common factors. As a result, the chances of thinking about a name and stumbling with any potential conflict of interest are high. Radical positions can impair selection, narrowing it towards the less experienced.</p>
      <p>Bedside bioethics understands that the manifestation of a conflict of interest in a guideline has the sole purpose of stating: &#8220;I give my word of honor that I have such theoretical potentials, but I did not put them to practice&#8221;.</p>
      <p>One can assume that people help accountable at the Brazilian Society of Cardiology preceded the reading of a new clinical guideline in the Brazilian Archives of Cardiology, including the decision on the need for updating/first time, selection of names, criticism and final approval. So, the focus of trust and responsibility is on corporate management.</p>
      <p>Management concerns can be simplified in the triad: absent information, biased information, qualified information. Any of these can be object of conflict of interest, hence the complexity. Hiding a novelty, forcing a recommendation or emphasizing endorsable evidence can embody personal interests or those of connected individuals.</p>
      <p>Bedside bioethics prefers to focus on fidelity to one's conscience when performing functions subject to the imperfections of human condition.<xref ref-type="bibr" rid="B3"><sup>3</sup></xref> Of course, strong associations with the industry should be avoided, as only being honest is not enough; one must avoid doubts.</p>
      <p>&#8216;Nevertheless, it is essential to consider that the behavior of members of a guideline committee will invariably be responsibility of the group, with priority interest aimed for the collectivity, rejecting any automaton expression within the group, respecting the criticism by the lead coordinator, walking side to side with research findings and bedside reality; to sum up: freedom and independence well supported by the updated and validated scientific platforms.</p>
      <p>One can guess that it would be na&#239;ve to trust the imperative of conscience<xref ref-type="bibr" rid="B4"><sup>4</sup></xref> that even an expert, a professor PhD, any juror of Hippocrates, committed to society by the possession of a medical register, cannot help but be dragged by the superficiality of a spurious interest when deep knowledge and wisdom is required of them. It is a valid counterpoint, but&#8212;and there is always a but&#8212;who would deny that the manifestation of conflict of interests not only does not allow the necessary discounts to be defined at the reception, but also does not function as a moral agent 007, bearing a license to conflict. There are suppositions of strategic exaggeration, a tendency for the issuer to provide more biases to offset the reception discounts caused by conflicts of interest. On the other hand, it can inhibit opposition by the fear that it might lead to a conflict of interest.</p>
      <p>Eubulides de Miletus asked this question 26 centuries ago: At what point does a pile of sand cease to exist? When grains are removed? Or do grains become a pile by successive addition? The answer is only possible if we look from an authoritarian point of view, if someone establishes a criterion with some type of imposing force. How much flexibility can be tolerated in a guideline committee member's opinion?</p>
      <p>Given the presumption of professional honesty by the partners, which should prevail in a specialty society, and given the difficulty in perceiving conflicts of interest in the contemporary setting of medicine, full of undetermined and accelerated metamorphoses, I believe that a potential conflict of interests is an inseparable part of the elaboration of any clinical guideline, and that any kind of certainty of its absence is impossible. Therefore, a guideline is not a handcuff, but rather a compass. Individual adjustments are welcome.</p>
      <p>Therefore, regardless of the expression of interests of each member of the guideline committee pertinent to the document, I propose a manifestation at the beginning of each guideline: since the decision of creation until the authorization of this publication, The Brazilian Society of Cardiology kept the confidence in the good faith of participants, a virtue that makes scientific truth a value underlying the relationships with oneself and with colleagues and patients.</p>
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