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05 mayo, 2013

Maternal folic acid supplements associated with reduced autism risk in the child

Evid Based Med doi:10.1136/eb-2013-101311
  • Aetiology
  • Cohort study

Maternal folic acid supplements associated with reduced autism risk in the child

  1. Rebecca J Schmidt
+ Author Affiliations
  1. Public Health Sciences, University of California Davis, Davis, California, USA
  1. Correspondence to: Dr Rebecca J Schmidt
    Public Health Sciences, University of California Davis, One Shields Ave, Davis, CA 95616, USA; rjschmidt@ucdavis.edu
Commentary on: Surén P, Roth C, Bresnahan M, et al. Association between maternal use of folic acid supplements and risk of autism spectrum disorders in children. JAMA 2013;309:570–7.

Context

Autism spectrum disorder (ASD) prevalence is increasing. Maternal periconceptional folic acid intake was associated with reduced ASD risk in a large, population-based case–control study.1 Surén and colleagues examined whether maternal folic acid supplements were associated with reduced risk for ASD.

Methods

The Norwegian Mother and Child Cohort Study (MoBa) included 85 176 children at least 3 years old born between 1999 and 2009. Questionnaire information on maternal supplement use was obtained around 18-week gestation.

Findings

The 270 MoBa children diagnosed with ASD included 114 with autistic disorder, 56 with Asperger syndrome and 100 with pervasive developmental disorder, not otherwise specified (PDD-NOS). Of the 61 042 children whose mothers took folic acid from 6 weeks before to 6 weeks after conception, 64 (0.10%) had autistic disorder, …
[Full text of this article]

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31 enero, 2012

Autores de articulos legalmente responsables en caso de lesiones del paciente


Proponen que los autores firmantes de un artículo sean legalmente responsables en caso de que el paciente sufra lesiones

JANO.es · 30 Enero 2012 1
Un triunvirato de expertos plantea que los médicos que avalen trabajos realizados según las directrices de laboratorios farmacéuticos sean legalmente responsables ante la posibilidad de que un paciente sufra lesiones.



Proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones.
El investigador español Xavier Bosch, del Hospital Clínic, ha planteado en un artículo publicado en PLoS Medicineque se adopten medidas legales para luchar contra el llamado ‘medical ghostwriting’, práctica consistente en conferir autoridad a un texto pseudopublicitario por el procedimiento de contratar la firma de un ‘autor invitado'.
Bosch y los coautores del artículo, Bijan Esfandiari, abogado en un bufete de Los Ángeles especializado en malas prácticas médicas, y Leemon McHenry, investigador del Departamento de Filosofía de la Universidad Estatal de California, recogen tres modelos teóricos de responsabilidad penal que afectarían principalmente a estos ‘guest authors’.
Así, los expertos proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones por causa de una práctica que aquéllos han avalado, y plantean que esas mismas responsabilidades se extiendan a las empresas patrocinadoras. Ambos planteamientos se basan en que los artículos pueden influir en el juicio clínico, aumentar las ventas de productos y los costes de atención sanitaria del gobierno, y poner a los pacientes en riesgo.
Los autores también consideran una forma de ghostwriting “las conferencias y los congresos médicos sobre enfermedades en los que se habla de los beneficios de un producto, si el discurso ha sido preparado a partir de las directrices de una compañía”.
►Ver artículo en PLoS MEDICINE
  • Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
  • In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
  • For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
  • In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
  • Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
  • Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.




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