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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 pub-id-type="publisher-id" specific-use="scielo-v3">4vx6FRdNZ9X6tRwj3gdM8mr</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v2">S0066-782X2020000600753</article-id>
      <article-id pub-id-type="publisher-id">abc.20200320</article-id>
      <article-id pub-id-type="doi">10.36660/abc.20200320</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Editorial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Pandem&#244;nio Durante a Pandemia: Qual o Papel dos Profissionais da Sa&#250;de e a Ci&#234;ncia?</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0001-8769-1411</contrib-id>
          <name>
            <surname>d&#8217;Avila</surname>
            <given-names>Andr&#233;</given-names>
          </name>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Melo</surname>
            <given-names>Marco F. Vidal</given-names>
          </name>
          <xref ref-type="aff" rid="aff2">
            <sup>2</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Lopes</surname>
            <given-names>Renato D.</given-names>
          </name>
          <xref ref-type="aff" rid="aff3">
            <sup>3</sup>
          </xref>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution content-type="orgdiv1">Servi&#231;o de Arritmia Card&#237;aca</institution>
        <institution content-type="orgname">Hospital SOS Cardio</institution>
        <addr-line>
          <named-content content-type="city">Florian&#243;polis</named-content>
          <named-content content-type="state">SC</named-content>
        </addr-line>
        <country country="BR">Brasil</country>
        <institution content-type="original">Servi&#231;o de Arritmia Card&#237;aca, Hospital SOS Cardio, Florian&#243;polis, SC &#8211; Brasil</institution>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution content-type="orgdiv2">Critical Care and Pain Medicine</institution>
        <institution content-type="orgdiv1">Massachusetts General Hospital</institution>
        <institution content-type="orgname">Harvard Medical School</institution>
        <addr-line>
          <named-content content-type="city">Boston</named-content>
          <named-content content-type="state">MA</named-content>
        </addr-line>
        <country country="US">USA</country>
        <institution content-type="original">Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA &#8211; USA</institution>
      </aff>
      <aff id="aff3">
        <label>3</label>
        <institution content-type="orgdiv2">Duke Clinical Research Institute</institution>
        <institution content-type="orgname">Duke University</institution>
        <institution content-type="orgdiv1">School of Medicine</institution>
        <addr-line>
          <named-content content-type="city">Durham</named-content>
          <named-content content-type="state">NC</named-content>
        </addr-line>
        <country country="US">USA</country>
        <institution content-type="original">Division of Cardiology, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC &#8211; USA</institution>
      </aff>
      <author-notes>
        <corresp id="c01"> Correspond&#234;ncia: Andre d&#8217;Avila &#8226; Hospital SOS Cardio - Servi&#231;o de Arritmia Card&#237;aca - SC 401.121. CEP 88030-000, Florian&#243;polis, SC &#8211; Brasil E-mail: <email>andredavila@mac.com</email>
				</corresp>
      </author-notes>
      <pub-date date-type="pub" publication-format="electronic">
        <day>01</day>
        <month>06</month>
        <year>2020</year>
      </pub-date>
      <pub-date date-type="collection" publication-format="electronic">
        <month>05</month>
        <year>2020</year>
      </pub-date>
      <volume>114</volume>
      <issue>5</issue>
      <fpage>753</fpage>
      <lpage>754</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 Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. </license-p>
        </license>
      </permissions>
      <kwd-group xml:lang="pt">
        <kwd>Coronavirus</kwd>
        <kwd>COVID-19</kwd>
        <kwd>Pandemias</kwd>
        <kwd>Hydroxychloroquina/efeitos da medica&#231;&#227;o</kwd>
        <kwd>Azitromicina/efeitos adversos</kwd>
        <kwd>Aprova&#231;&#227;o de Drogas</kwd>
        <kwd>Comit&#234; de &#201;tica em Pesquisa</kwd>
        <kwd>M&#237;dias Sociais</kwd>
      </kwd-group>
      <counts>
        <fig-count count="0"/>
        <table-count count="0"/>
        <equation-count count="0"/>
        <ref-count count="1"/>
        <page-count count="2"/>
      </counts>
    </article-meta>
  </front>
  <body>
    <p>A conduta dos comentaristas esportivos brasileiros durante a recente pandemia da COVID-19 merece destaque. Dia ap&#243;s dia, mesmo socialmente distantes, eles v&#234;m &#224; televis&#227;o dar a sua contribui&#231;&#227;o para amenizar o desconforto do p&#250;blico. Durante horas, discutem exaustivamente jogos do passado, problemas atuais e o futuro do esporte sobre o qual se especializaram. Em nenhum momento, no entanto, se arriscam a coment&#225;rios fora da sua &#225;rea. Mesmo que, como cidad&#227;os, tenham uma opini&#227;o sobre a gravidade da COVID-19, sobre o benef&#237;cio do distanciamento social ou sobre o uso de medicamentos sem comprova&#231;&#227;o cient&#237;fica, preferem continuar restritos &#224;s &#225;reas de excel&#234;ncia nas quais s&#227;o reconhecidos como especialistas, pois conhecem aquele assunto melhor que ningu&#233;m.</p>
    <p>Mais dif&#237;cil de compreender, entretanto, &#233; a postura dos que insistem em emitir opini&#227;o n&#227;o fundamentada sobre v&#225;rias interven&#231;&#245;es no tratamento da COVID-19, mesmo sabendo que n&#227;o h&#225; confirma&#231;&#227;o baseada em alto n&#237;vel de evid&#234;ncia do potencial efeito ben&#233;fico dessas recomenda&#231;&#245;es. Alguns simplesmente optam pelo proselitismo m&#233;dico. Outros, por n&#227;o reconhecerem nem entenderem a necessidade da investiga&#231;&#227;o cl&#237;nica adequada, preferem a omiss&#227;o: n&#227;o aprovam nem desaprovam nada, deixando a popula&#231;&#227;o sem nenhum referencial.<sup><xref ref-type="bibr" rid="B1">1</xref></sup> Contudo, o tipo de atitude mais comum talvez seja a do m&#233;dico assustado pelo desconhecido, desesperado por seus entes queridos e pacientes, pressionado por respostas e influenciado pelo bombardeio das informa&#231;&#245;es nas m&#237;dias sociais e que, por isso, agarra-se &#224; possibilidade de um tratamento redentor. Infelizmente, a &#250;nica doen&#231;a tratada com essa abordagem costuma ser a ansiedade dos pr&#243;prios m&#233;dicos e seus pacientes.</p>
    <p>Dentro desse panorama desolador de incertezas, informa&#231;&#245;es desencontradas e aus&#234;ncia de lideran&#231;as, a torrente de asser&#231;&#245;es com in&#237;cio e eco nas in&#250;meras m&#237;dias sociais transforma em verdade (ou pelo menos em expectativa) tudo o que &#233; divulgado em primeira m&#227;o, por mais absurdo que seja. O &#250;nico interesse &#233; a not&#237;cia em si. As consequ&#234;ncias n&#227;o importam. Entretanto, ao desprezar o m&#233;todo cient&#237;fico rigoroso, com o &#225;libi de tentar ajudar, criam um ambiente de confus&#227;o &#8211; ou pior, um ambiente que aumenta o risco daqueles que tomam tais asser&#231;&#245;es como verdadeiras.</p>
    <p>O rigor cient&#237;fico e &#233;tico da pesquisa como um todo, e na &#225;rea m&#233;dica em especial, beneficiou milhares de pacientes em todo o mundo por meio da pesquisa criteriosa, sem atalhos, realizada sob a orienta&#231;&#227;o cuidadosa da Declara&#231;&#227;o de Helsinki de 1964. O princ&#237;pio b&#225;sico da Declara&#231;&#227;o &#233; o respeito ao indiv&#237;duo que deve consentir sua participa&#231;&#227;o e perman&#234;ncia no protocolo de pesquisa, visto que seus interesses precedem os interesses da ci&#234;ncia e da sociedade. No entanto, se o interesse do paciente se imp&#245;e aos interesses cient&#237;ficos, como justificar a necessidade de randomizar algu&#233;m que possa eventualmente ter o &#8220;azar&#8221; de ser alocado no grupo controle, talvez placebo, se no outro extremo existe, ou pelo menos se sup&#245;e que exista, esperan&#231;a de cura?</p>
    <p>A resposta a essa pergunta deriva da aceita&#231;&#227;o do m&#233;todo cient&#237;fico: somente a demonstra&#231;&#227;o objetiva e quantific&#225;vel, acima de mera casualidade da efic&#225;cia e efetividade de qualquer interven&#231;&#227;o, merece aceita&#231;&#227;o, ainda que v&#225;rias ideias pare&#231;am vi&#225;veis e eficazes em etapas preliminares. A exist&#234;ncia do grupo controle &#233; essencial nesse aspecto. Este deve oferecer ao participante do ensaio cl&#237;nico uma rela&#231;&#227;o benef&#237;cio/risco presumivelmente equivalente (&#8220;equipoise&#8221;) &#224;quela da interven&#231;&#227;o baseada nas evid&#234;ncias dispon&#237;veis quando da implementa&#231;&#227;o do estudo. Assim, uma medida objetiva de comparabilidade da interven&#231;&#227;o &#233; imposta e deve ser vencida. Al&#233;m disso, sabe-se que pacientes que participam de ensaios cl&#237;nicos evoluem melhor que aqueles que n&#227;o entram em tais pesquisas, mesmo quando alocados ao grupo controle ou placebo. Lembremos, portanto, que a maneira mais segura de tratar um paciente quando n&#227;o temos a resposta &#233; inclu&#237;-lo em um ensaio cl&#237;nico, pois somente assim haver&#225; o melhor tratamento poss&#237;vel, sob supervis&#227;o direta, enquanto ajuda o avan&#231;o da ci&#234;ncia. A hist&#243;ria da medicina &#233; farta de exemplos de tratamentos considerados &#8220;absolutamente efetivos&#8221; que mostraram-se f&#250;teis ou at&#233; mal&#233;ficos ap&#243;s a realiza&#231;&#227;o dos ensaios cl&#237;nicos randomizados, considerado o padr&#227;o-ouro para se definir efic&#225;cia e seguran&#231;a de qualquer interven&#231;&#227;o em medicina.</p>
    <p>Na cardiologia, casos de futilidade e malef&#237;cios s&#227;o in&#250;meros e gritantes. O uso de f&#225;rmacos antiarr&#237;tmicos para preven&#231;&#227;o de morte s&#250;bita em pacientes com extrass&#237;stoles ventriculares ap&#243;s infarto agudo do mioc&#225;rdio (IAM), de magn&#233;sio para redu&#231;&#227;o da &#225;rea infartada e de betabloqueador na s&#237;ncope vasovagal consiste em alguns exemplos da enorme diferen&#231;a entre a expectativa (ou o senso comum) e o real efeito de interven&#231;&#245;es terap&#234;uticas. Sem esses estudos, milhares de pacientes teriam sido submetidos a procedimentos ineficazes, dos quais, em vez de benef&#237;cios, derivariam apenas complica&#231;&#245;es.</p>
    <p>Na situa&#231;&#227;o atual de enfrentamento da COVID-19, vale a pena mencionar que todas as alternativas supostamente milagrosas (desde o uso de doses maci&#231;as de vitamina C, D e zinco at&#233; o uso de macrol&#237;dios, cloroquina e derivados, corticosteroides, antivirais e outras medica&#231;&#245;es) j&#225; foram testadas em outras viroses e epidemias, tais como HIV, Ebola e H1N1. Infelizmente, apesar da expectativa inicial, n&#227;o se mostraram seguras ou eficazes nesses ensaios anteriores.</p>
    <p>Naturalmente, o efeito de algumas dessas interven&#231;&#245;es pode ser diferente na pandemia atual. Tal hip&#243;tese, no entanto, precisa ser avaliada e provada com todo o rigor cient&#237;fico que a urg&#234;ncia e a gravidade da situa&#231;&#227;o imp&#245;em. Infelizmente, a maioria dos trabalhos iniciais utilizados para basear a indica&#231;&#227;o de diversas interven&#231;&#245;es no combate &#224; COVID-19 &#233; um exemplo de pseudoevid&#234;ncia. S&#227;o cientificamente ris&#237;veis.</p>
    <p>Tomemos como exemplo o estudo que popularizou a hidroxicloroquina<sup><xref ref-type="bibr" rid="B1">1</xref></sup> (aquele citado por Donald Trump como tendo &#8220;probabilidade de ser uma das maiores descobertas da hist&#243;ria da medicina&#8221;). Os autores do trabalho investigavam se pacientes com COVID-19 teriam melhor desfecho com a hidroxicloroquina. Para tanto, teria sido mandat&#243;rio que, de dois grupos semelhantes de pacientes, apenas um tivesse recebido o f&#225;rmaco. Parece elementar, mas n&#227;o foi isso que aconteceu: al&#233;m do rem&#233;dio diferente, os grupos eram de hospitais distintos, tinham idades diversas, apresentavam condi&#231;&#245;es cl&#237;nicas e tratamentos variados, al&#233;m de cargas virais diferentes. Assim, como isolar o efeito do rem&#233;dio? Al&#233;m disso, os quatro pacientes que morreram ou foram &#224; unidade de terapia intensiva (UTI) &#8211; ali&#225;s, todos tomando hidroxicloroquina &#8211; foram eliminados dos resultados, o que sugere que, para alguns, um &#243;bito possa ser menos relevante do que a detec&#231;&#227;o de v&#237;rus na nasofaringe. Al&#233;m disso, o tamanho da amostra, queixa comum de v&#225;rios revisores, foi muito pequeno, n&#227;o permitindo definir qualquer poss&#237;vel efeito de tratamento.</p>
    <p>&#201; decepcionante quando um estudo n&#227;o consegue responder &#224; pergunta proposta. &#201; pior quando isso gera uma convuls&#227;o social. O mais dram&#225;tico, no entanto, &#233; saber que tal artigo passou por uma revis&#227;o de pares e por um editor que, se tivesse agido de forma respons&#225;vel, abrindo m&#227;o do frenesi do aumento do n&#250;mero de acessos ao <italic>website</italic> da revista e da notoriedade imediata, poderia ter evitado essas consequ&#234;ncias em bola de neve. Uma pandemia n&#227;o justifica o esquecimento da ci&#234;ncia e os erros que criam falsas esperan&#231;as que potencialmente coloquem vidas em risco.</p>
    <p>A atitude de m&#233;dicos e cientistas no mundo varia com rela&#231;&#227;o &#224; interpreta&#231;&#227;o desses dados. Muitos acham que aquela evid&#234;ncia sobre o uso da cloroquina justifica a prescri&#231;&#227;o do medicamento, mas essa posi&#231;&#227;o est&#225; longe de ser un&#226;nime. V&#225;rios colegas m&#233;dicos que contra&#237;ram a COVID-19 aceitaram participar de estudos cl&#237;nicos randomizados, contribuindo para que uma resposta metodologicamente adequada fosse alcan&#231;ada, com potencial benef&#237;cio a milhares de pessoas. Nesse sentido, para esta e outras eventuais pandemias, vale lembrar que somente estudos cl&#237;nicos rigorosos realizados com a colabora&#231;&#227;o de profissionais, hospitais e sociedades m&#233;dicas do mundo todo, e liderados por especialistas em pesquisa cl&#237;nica, podem oferecer as respostas corretas, nos livrando da mazela do curandeiro, que capitaliza o sucesso da eventual melhora e, no caso de um desfecho inadequado, sugere que o paciente n&#227;o foi merecedor da d&#225;diva por ele oferecida.</p>
    <p>M&#233;dicos, outros profissionais da sa&#250;de, cientistas e as sociedades que os representam t&#234;m o dever de nos livrar do retrocesso que o n&#227;o entendimento do m&#233;todo cient&#237;fico acarreta, al&#233;m da obriga&#231;&#227;o de nos lembrar de que o senso comum erra e que nosso estado de humor coletivo n&#227;o pode justificar deslizes metodol&#243;gicos que possam impactar milhares de vidas. Espera-se que os m&#233;dicos fa&#231;am o que sabem fazer de melhor: agir &#224; luz da &#233;tica, de forma pragm&#225;tica, com base no melhor que a ci&#234;ncia pode oferecer. Sejamos realmente especialistas quando os dados de alta qualidade cient&#237;fica estiverem dispon&#237;veis. Afinal, a verdade sempre prevalece, e a ci&#234;ncia &#233; a ferramenta que mais rapidamente nos aproxima dela. Como m&#233;dicos e cientistas, nosso papel &#233; encurtar o caminho entre a hip&#243;tese e a conclus&#227;o fundamentada, tanto para benef&#237;cio dos pacientes sob nossa responsabilidade quanto para a popula&#231;&#227;o que anseia por uma resposta segura da ci&#234;ncia m&#233;dica.</p>
  </body>
  <back>
    <ack>
      <title>Agradecimentos</title>
      <p>Os autores gostariam de agradecer o Dr. Andre Zimerman e ao sr. Julio Tude d&#8217;Avila pelas sugest&#245;es e revis&#227;o critica desse manuscrito.</p>
    </ack>
    <ref-list>
      <title>Refer&#234;ncias</title>
      <ref id="B1">
        <label>1</label>
        <mixed-citation>1. Gautret P, Lagier JC, Parola P, Hoang VT, Medded L, Mailhe M, et al. Hydroxychloroquine and Azithromycin as a Treatment of COVID-19: Results of an Open-Label Non-Randomized Clinical Trial. Int J Antimicrob Agents. 2020 March ; In Press DOI: 10.1016/j.ijantimcag.2020.105949</mixed-citation>
        <element-citation publication-type="journal">
          <person-group person-group-type="author">
            <name>
              <surname>Gautret</surname>
              <given-names>P</given-names>
            </name>
            <name>
              <surname>Lagier</surname>
              <given-names>JC</given-names>
            </name>
            <name>
              <surname>Parola</surname>
              <given-names>P</given-names>
            </name>
            <name>
              <surname>Hoang</surname>
              <given-names>VT</given-names>
            </name>
            <name>
              <surname>Medded</surname>
              <given-names>L</given-names>
            </name>
            <name>
              <surname>Mailhe</surname>
              <given-names>M</given-names>
            </name>
            <etal>et al</etal>
          </person-group>
          <article-title>Hydroxychloroquine and Azithromycin as a Treatment of COVID-19: Results of an Open-Label Non-Randomized Clinical Trial</article-title>
          <source>Int J Antimicrob Agents</source>
          <year>2020</year>
          <month>03</month>
          <comment>In Press</comment>
          <issue-id pub-id-type="doi">10.1016/j.ijantimcag.2020.105949</issue-id>
        </element-citation>
      </ref>
    </ref-list>
  </back>
  <sub-article article-type="translation" id="TRen" xml:lang="en">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Editorial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Pandemonium During the Pandemic: What is the Role of Health and Science Professionals?</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0001-8769-1411</contrib-id>
          <name>
            <surname>d&#8217;Avila</surname>
            <given-names>Andr&#233;</given-names>
          </name>
          <xref ref-type="aff" rid="aff1001">
            <sup>1</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Melo</surname>
            <given-names>Marco F. Vidal</given-names>
          </name>
          <xref ref-type="aff" rid="aff2001">
            <sup>2</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Lopes</surname>
            <given-names>Renato D.</given-names>
          </name>
          <xref ref-type="aff" rid="aff3001">
            <sup>3</sup>
          </xref>
        </contrib>
      </contrib-group>
      <aff id="aff1001">
        <label>1</label>
        <country country="BR">Brazil</country>
        <institution content-type="original">Servi&#231;o de Arritmia Card&#237;aca, Hospital SOS Cardio, Florian&#243;polis, SC &#8211; Brazil</institution>
      </aff>
      <aff id="aff2001">
        <label>2</label>
        <country country="US">USA</country>
        <institution content-type="original">Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA &#8211; USA</institution>
      </aff>
      <aff id="aff3001">
        <label>3</label>
        <country country="US">USA</country>
        <institution content-type="original">Division of Cardiology, Duke Clinical Research Institute, Duke University School of Medicine,Durham, NC &#8211; USA</institution>
      </aff>
      <author-notes>
        <corresp id="c01001"> Mailing Address: Andre d&#8217;Avila &#8226; Hospital SOS Cardio - Servi&#231;o de Arritmia Card&#237;aca - SC 401.121. Postal Code 88030-000, Florian&#243;polis, SC &#8211; Brazil E-mail: andredavila@mac.com </corresp>
      </author-notes>
      <kwd-group xml:lang="en">
        <kwd>Coronavirus</kwd>
        <kwd>COVID-19</kwd>
        <kwd>Pandemics</kwd>
        <kwd>Hydroxychloroquine/effects medication</kwd>
        <kwd>Azythromicine/adverse effects</kwd>
        <kwd>Drug Approval</kwd>
        <kwd>Ethics Committees, Research</kwd>
        <kwd>Social Media</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <p>The behavior of Brazilian sports commentators during the recent COVID-19 pandemic is noteworthy. Day after day, despite social distancing, they continued their television broadcasts to help ease their viewers&#8217; discomfort. For hours, they discussed past games, current problems and the future of the sport. At no time, however, did they make comments on topics outside of their area of expertise. Although they most certainly had an opinion on the seriousness of COVID-19, the merits of social distancing or use of medications popularized by many without scientific evidence, they restricted their commentary to their areas of expertise &#8211; sports!</p>
      <p>What has been hard to understand is the insistence of some physicians to provide opinions on unsubstantiated interventions for the treatment of COVID-19. Some simply choose medical proselytism. Others may not appreciate the need for proper scientific investigation. Many prefer to omit themselves from any debate. However, the most perplexing type of attitude is simply a reactionary behavior related to the fear of the unknown that is, the combination of desperation and need to provide care for patients, and bombardment of information from social media may bias many doctors to embrace any potential redemptive treatment. Unfortunately, the only disease treated with this approach is the anxiety shared by doctors and their patients.</p>
      <p>In this bleak scenario full of uncertainties, mismatched information, lack of leadership, and a raging torrent of assertions in social media can transform claims into truth (or at least into expectations), however absurd they may be. Unfortunately, disregarding strict scientific methods, using an alibi of trying to help, creates an atmosphere of confusion and increases the risk of those who implement such statements.</p>
      <p>The scientific and ethical rigor of research as a whole, and particularly in the medical field, has benefited thousands of patients around the world through careful research carried out under the guidance of the Declaration of Helsinki from 1964. The basic principle of the Declaration is respect for the individuals (who must consent to participate in the research protocol), as the individual&#8217;s interests precede that of science and society. However, if the patient&#8217;s interest is imposed then one logically will ask how is it possible to justify randomization given the fears patients or physicians may have with the possibility of having &#8220;bad luck&#8221; and being allocated to a control group, perhaps a placebo, when the alternative is perceived to be a hope for cure?</p>
      <p>The answer to this question requires understanding and acceptance of the scientific method. Although several ideas appear effective during preliminary stages, only objective demonstration of efficacy beyond mere chance merits acceptance. In that regard, a control group is indispensable to achieve this as it allows determination of the benefit/risk ratio (&#8220;equipoise&#8221;) of the intervention. While participation in a control group may be met with disappointment from some patients and physicians, it must be remembered that individuals who participate in clinical trials in general do better than those who do not participate in such studies, even when allocated to control or placebo groups. Thus a logical and safe way to treat a patient when an answer to a clinical question is not available is to include them in a clinical trial as these patients will be offered the best possible treatment, under direct supervision, while advancing science.</p>
      <p>The history of medicine is full of examples of treatments considered by experts as &#8220;absolutely effective&#8221; that clinical trials proved to be futile and even harmful. In cardiology, cases of futility and harm are numerous and even striking. The use of antiarrhythmic drugs to prevent sudden death in patients with ventricular extrasystoles after acute myocardial infarction (AMI), magnesium to reduce the infarcted area and beta-blockers in vasovagal syncope are examples of the huge difference between expectation (perceived &#8220;common sense&#8221;) and the actual effect resulting in a therapeutic upheaval.</p>
      <p>In the current situation of COVID-19, supposedly miraculous therapies (including supratherapeutic doses of vitamins [C, D, and zinc], macrolides, chloroquine and its derivatives, corticosteroids, antivirals and other medications) have been tested in clinical trials for other viruses including HIV, Ebola and H1N1 and, despite the expectations of efficacy in these conditions, none were shown to be safe or effective. While it may be assumed that the effect of some of these interventions might work differently in the current Covid pandemic, these beliefs will need to be evaluated with scientific rigor that the urgency and gravity of the situation entails.</p>
      <p>Unfortunately, most recommendations of interventions to fight COVID-19 are based in pseudo-evidence. The study that popularized hydroxychloroquine<xref ref-type="bibr" rid="B1"><sup>1</sup></xref> (<italic>the one cited by Donald Trump as having &#8220;a real chance to be one of the biggest game changers in the history of medicine&#8221;</italic>) is scientifically ludicrous. The authors of the study investigated whether patients with COVID-19 would have a better outcome with hydroxychloroquine. To that end, it would have been mandatory that two similar groups of patients would exist with only one receiving the drug. As simple as this seems, that is not what happened. In addition to the different drugs administered, the groups were from different hospitals, were of different ages, had different clinical conditions and received different additional treatments. Most notably, these patients had different viral loads. How is one to isolate the effect hydroxychloroquine when such marked differences are present? On top of that, four patients who died or went to the intensive care unit (ICU) who received hydroxychloroquine were eliminated from the results suggesting that for some investigators death may be less relevant than the detection of a virus in the nasopharynx. Finally, the sample size was very small not allowing any possible effect from the treatment to be defined.</p>
      <p>While it is disappointing when a study fails to answer the proposed question, it is worse when it creates social upheaval. This article was peer-reviewed by colleagues and by an editor who could have avoided consequences of this publication had they acted responsibly. A pandemic does not justify forgetting science as mistakes create false hopes that may potentially put lives at risk.</p>
      <p>There has been variable interpretation of these data by the medical community throughout the world. Whereas many believe that the use of chloroquine is justifiable, that stance is far from unanimous. Many health care workers diagnosed with COVID-19 agreed to participate in randomized clinical trials to help create high-quality data that may potentially benefit thousands of people. It is remarkable that the medical community would band together as subjects in a clinical trial to generate data for a disease they are helping the public fight! This is the correct decision. Only properly designed and executed clinical studies conducted by professionals, hospitals and medical societies globally, and led by experts in clinical research, can offer accurate answers. The medical fraternity has a duty to free us from the setbacks created by the failure to understand scientific methods. &#8220;Common sense&#8221; and our collective mood cannot justify methodological errors which in turn may adversely impact thousands of lives. Physicians are expected to do what they best do - act in the light of ethics, pragmatically, based on the best that science can offer. Let us be genuine specialists when high-quality scientific data is available. After all, truth always prevails, and science is the tool that most rapidly draws us closer to it. As doctors and scientists, our role is to abate the gap between assumptions and reasoned conclusions as this will benefit patients and the population that yearns for answers provided by medical science.</p>
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        <title>Acknowledgment</title>
        <p>The authors would like to thank Dr. Andre Zimerman, Dr. Sheldon Singh (English version) and Mr. Julio Tude d&#8217;Avila for their critical suggestions and review of the manuscript</p>
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