Journal of Internal Medicine – IS MEDICAL ETHICS REALLY IN THE BEST INTEREST OF THE PATIENT?

ETHICS SYMPOSIUM: IS MEDICAL ETHICS REALLY IN THE BEST INTEREST OF THE PATIENT?

vía Journal of Internal Medicine – Volume 269, Issue 4 – April 2011 – Wiley Online Library.

1. Introduction

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   Is medical ethics doing its job? (pages 366–369)M. G. Hansson and R. Chadwick

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02348.x

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2. Part l: Should ideology be allowed to trump patient well-being?

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   Viewpoint: Interests, rights and standards of care in the context of globalized medicine (pages 370–374)H. Haker

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02349_1.x

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   Viewpoint: How to avoid a dichotomy between autonomy and beneficence: from liberalism to communitarianism and beyond (pages 375–379)M. Sutrop

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02349_2.x

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   Commentary: Autonomy revisited – a response to H. Haker (pages 380–382)Alastair V. Campbell

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02349_3.x

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5. Part ll: The (mis)use of informed consent in medical research

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   Viewpoint: Why our conceptions of research and practice may not serve the best interest of patients and subjects (pages 383–387)T. L. Beauchamp

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02350_1.x

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   Commentary: The distinction between research and practice – a response to T. Beauchamp (pages 388–391)M. F. Verweij

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02350_2.x

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7. Part lll: Ethical review boards: Important ethical safeguards or over-burdensome and unnecessary bureaucracy?

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   Viewpoint: Are the research ethics committees working in the best interests of participants in an increasingly globalized research environment? (pages 392–395)D. Chalmers

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02351_1.x

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   Viewpoint: A method to estimate the cost in lives of ethics board review of biomedical research (pages 396–402)S. N. Whitney and C. E. Schneider

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02351_2.x

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   Commentary: Systems, rules and the costs of being ethical – a response to D. Chalmers and to S. Whitney and C. Schneider (pages 403–406)S. Holm

   Article first published online: 15 MAR 2011 | DOI: 10.1111/j.1365-2796.2011.02351_3.x

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IX CONGRESSO BRASILEIRO DE BIOÉTICA

IX CBB & I CBBC. http://www.congressobioetica2011.com.br

Brasília, 7 a 10 de Setembro de 2011

IX  CONGRESSO BRASILEIRO DE BIOÉTICA. O tema oficial escolhido para o evento foi UMA DÉCADA DEPOIS: BIOÉTICA(S), PODER(ES) E INJUSTIÇA(S), relacionado  com  as  transformações  verificadas  na  epistemologia  da bioética  após  o  transcurso  de  quase  10  anos  do  Sexto  Congresso Mundial realizado em Brasília, que teve como tema “Bioética, Poder e Injustiça” e politizou definitivamente a agenda bioética internacional.

Science as a public enterprise: the case for open data

Science as a public enterprise: the case for open data

vía Science as a public enterprise: the case for open data : The Lancet.

Uno de los requisitos de la ciencia es la publicidad. Toda la comunidad científica debe tener acceso a los datos experimentales sobre los que se edifica nuevo conocimiento público, que puede ser refutado, o no ser reproducible en ámbitos experimentales similares o diferentes.

Pero actualmente parecería que el objetivo de la ciencia, o al menos de gran parte de la investigación biomédica, no es la producción de conocimiento sino de patentes. Esto lleva al aborrecible concepto de propiedad exclusiva de los datos de investigación, o “data exclusivity”, lo cual imposibilita la reproducción de los ensayos clínicos por otros investigadores, obligando a quienes quieran verificar sus conclusiones a reproducir el ensayo en nuevos seres humanos. Esto está totalmente reñido con la ética de la investigación con seres humanos, al aumentar el  riesgo para un nuevo grupo de personas.

Pero el objetivo primario de la industria farmacéutica NO es la producción de conocimiento sino de beneficios económicos para sus accionistas. Este objetivo está en abierta contradicción con el de producir conocimiento público generalizable, y con el de beneficiar a la salud pública o a la humanidad.

Parece interesante, entonces, que se haya generado un debate al respecto. El trabajo “Science as a public enterprise: the case for open data”, de Geoffrey Boulton, Michael Rawlins, Patrick Vallance y Mark Walport, publicado hoy en The Lancet, Volume 377, Issue 9778, Pages 1633 – 1635, propone una nueva reflexión sobre el tema.

(se recomienda leerlo teniendo en cuenta que MR is the Chairman of the National Institute for Health and Clinical Excellence. PV is a Senior Vice President at GlaxoSmithKline. MW is the Director of the Wellcome Trust. GB has received travel support from the Royal Society. PV holds stock or stock options in GlaxoSmithKline, is a board member (no remuneration) of Tempero Pharmaceuticals, A*Star Board Singapore and NY Stem Cell Foundation. PV and MW are both board members of Genome Research Limited and Oschr. MR declares that he has no conflicts of interest). Los demás sí lo tienen.

Al final del paper consignan que “the UK’s Royal Society has established a Working Group to explore them in depth and to make recommendations about how they might be addressed. The Working Group now seeks evidence from scientists and from the public.“

Si uno se fija en la página web del Working Group encuentra que sostienen que “A case for open access to research data is most obvious where the research has been done at public expense, or where the research has involved experimentation on human beings who have consented to be subjected to risks for the benefit of the public (as in the case of medical research).” lo cual constituye un buen punto de partida.

La página del Proyecto “Science as a public enterprise” es http://royalsociety.org/policy/sape/, y va a ser muy interesante ver como evolucionan sus posiciones…

La compra de opiniones

KOL es un acrónimo que significa Key Opinion Leader. O sea lider de opinión clave, y se refiere a personas de prestigio, profesional, académico, etc, que son cooptadas por la industria farmacéutica para que opinen públicamente a favor de sus productos, líneas de investigación, etc. Según explican en esta página web “KOL is shorthand for Key Opinion Leader, a term used to define the expert physicians, health care providers, and educators who lead the medical community in advancing better public health through research, publishing, and clinical practice.”

Thought Leader Select is a specialty firm dedicated to facilitating better collaborations among companies in the biopharmaceutical and healthcare industries and the medical community, all of whom work diligently to promote better public health.

Promover las ventas de la industria farmacéutica es promover la mejor salud pública?

vía KOL Services | Thought Leader Select.

Según ellos:

Our assessments of the medical community have featured the following groups of health care professionals (HCPs):

• Physicians
• Nurses
• Nurse Practitioners
• Physician Assistants
• Medical Educators
• Dentists
• Veterinarians

Thought Leader Select offers the following services to its clients, who number over two dozen of the world’s largest biopharmaceutical and health care companies:

• Key Opinion Leader (KOL) Identification
• Key Opinion Leader (KOL) Profiling
• Key Opinion Leader (KOL) Engagement Planning
• Key Opinion Leader (KOL)  Mapping
• Key Opinion Leader (KOL) Interviews and Surveys
• Medical Centers of Excellence (COE) Identification
• Medical Centers of Excellence (COE) Profiling
• Research and Technology Support

Es una ejemplo muy ilustrativo del grado de entretejido entre la industria farmacéutica y los profesionales del sector salud. Por cierto, esto se hace a plena luz del día, y se considera legal…

Pero cuando algunos legisladores se alarman, y quieren limitarlo legalmente a través de medidas que arrojen más luz (Sunshine Act) sobre estas relaciones, aparecen reacciones de molestia entre esta pobre gente.

The Sunshine Act: Who Pays for It Anyway?

Se preguntan, preocupadísimos por la salud pública: “All of this capturing and reporting millions and millions of transactions between manufacturers and physicians at the expense of spending healthcare dollars on delivering better health to the nation smacks of squandering limited resources at a time when the economy is squeezing access to healthcare for most people.”

¡Hay que cuidar el healthcare dollar cuando no va a parar a sus bolsillos!

Report | Office of Evaluation and Inspection | Office of Inspector General

We determined using medical record review that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with the condition specified in the FDA boxed warning.

vía Report | Office of Evaluation and Inspection | Office of Inspector General.

Sin comentarios.

Metaanálisis? Si, pero hay que fijarse quien los hace!

Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs

vía Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review — — bmj.com.

What is already known on this topic

Bias commonly occurs in trials of healthcare interventions and often favours the sponsor’s product

Anecdotal reports have suggested that industry supported meta-analyses may also be more flawed than other meta-analyses

What this study adds

Industry supported reviews were of lesser quality than Cochrane reviews of the same drugs and always recommended the experimental drug without reservations, which none of the Cochrane reviews did

Industry supported meta-analyses of drugs were less transparent and had few reservations about methodological limitations of included trials

Reviews with undeclared support and those with not for profit support or no support had similarly cautious conclusions to matched Cochrane reviews

The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review — Sun et al. 342 — bmj.com

Research

The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review

vía The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review — Sun et al. 342 — bmj.com.

Conclusion

Randomised controlled trials published in high impact journals, with larger sample size, studying non-surgical topics, and with industry funding—if the primary outcome is not statistically significant—are associated with more frequent reporting of subgroup analyses. The proportion of trials prespecifying subgroup hypotheses and carrying out interaction tests for subgroup analyses is low in both industry funded and non-industry funded trials. Industry funded trials, regardless of the statistical significance of primary outcomes, less often prespecify subgroup hypotheses and less often use the interaction test for analyses of subgroup effects compared with trials that are not funded by industry. Our findings suggest that clinicians, reviewers, and journal editors should view all subgroup analyses with caution. Particular attention is warranted in industry funded trials with negative results for the primary outcome.

PLoS Medicine: Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature

PLoS Medicine: Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature.

De como toda la propaganda sobre este medicamento estaba basada en 1 (un) estudio, que además era técnicamente limitado…