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Justicia en el acceso a la tecnología emergente: la terapia génica desde Latinoamérica

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Abstract

La tecnología en salud avanza rápidamente en la búsqueda por mejorar la condición humana. No obstante, la innovación tecnológica implica cuestiones técnicas, metodológicas, legales, éticas y morales que varían según el contexto sociocultural. Así, reconocemos un problema determinado geográficamente, el acceso justo a la tecnología emergente, que apremia a Latinoamérica. Se toma como ejemplo la terapia génica para reconocer, a partir de una revisión bibliográfica, por qué los investigadores están a favor, en medio o en contra del avance tecnológico en genética y del uso de la terapia génica en seres humanos. Concluimos que la justicia social debe ir más allá de la simple distribución de bienes, materiales y recursos. Por ello, enfatizamos la necesidad de un enfoque transdisciplinario que acompañe el avance tecnológico desde el punto de vista jurídico y filosófico, y proponemos el valor bioético de la solidaridad como pilar para la toma de decisiones futuras.
 49
Justicia en el acceso a la tecnología emergente:
la terapia génica desde Latinoamérica
Fair access to emerging technology: gene therapy in Latin America



Resumen
           


      
     








Abstract

      




 

   



Palabras clave

50
Keywords



Introducción


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 51










 




Tabla 1. Ejemplos de tecnologías emergentes en salud
Área del conocimiento Aplicación en la salud

      


 



   

   






La innovación tecnológica como móvil de la inequidad



   

52
  







 
       







     
         



  
     




   

 








 53
    


Revisión de los estudios









          

























54
Figura 1. Coocurrencias de la revisión





 


 








 55
Tabla 2. Resultado de la revisión
Argumento Autor/es (año)

 
       
      








Punto
medio
      
 

     



  
 
 




     
      







  










56





     

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

  
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
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   
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


 57
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
58









Conclusión


   
    
 



 





        




         







 
 59
      




     













        
         






     
   



 






60
Referencias
         



          



         












             
        
 

           
        


   


        


           

 61
           



 



        

       










          


    












  

62



Ordenamientos legales


... Por ello, las tecnologías emergentes deben analizarse desde un contexto distinto a otros bienes de acceso a la salud. "Las tecnologías emergentes, guiadas por la Solidaridad, podrían (y deberían) transformarse en un bien público con un impacto benéfico para todos" (Díaz Torres, 2022 ...
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A medida que la humanidad avanza, el pensamiento humano evoluciona y se enfrenta a nuevos dilemas. De estas reflexiones surgen movimientos y posturas filosóficas como el transhumanismo; una corriente de pensamiento que busca superar las limitaciones humanas a través de la tecnología. A lo largo de este libro se explorarán las ramificaciones filosóficas, éticas y bioéticas de este fascinante movimiento, el cual cada vez se vuelve más influyente. En este contexto nace este libro, fruto del trabajo colectivo de un grupo de investigadores latinoamericanos dedicados a examinar las implicaciones y consecuencias del transhumanismo. Este esfuerzo conjunto es especialmente significativo, dado que la gran mayoría de las discusiones sobre este asunto, han tenido lugar principalmente en el ambiente anglosajón. Por lo tanto, este libro representa un hito al aportar la perspectiva y las reflexiones de América Latina, una región rica en diversidad cultural, social y filosófica. La primera parte de esta publicación se dedica a una serie de reflexiones filosóficas sobre el transhumanismo. Para esto se explorará el concepto de “Techné” como herramienta de mejora humana, centrándose en cómo la tecnología puede ampliar nuestras capacidades. Este enfoque nos lleva a la discusión sobre “La muerte de la Muerte: vida exponencial y transhumanismo”. En esta sección, consideraremos la posibilidad de la superlongevidad y la cuestión de si realmente queremos, o debemos, aspirar a vivir más de 120 años.
... Como se ha dicho con antelación, a cada época histórica le corresponde una multiplicidad de dispositivos que la hacen funcionar conforme a sus límites de sentido social, político, económico y cultural. Por ello, en la era algorítmica encontramos dispositivos digitales en ámbitos que van desde el periodismo algorítmico (García Orosa et al., 2023), la pandemia y la redimensión del espectáculo (Avaro, 2021), el desempleo por procesos de automatización algorítmica (Prodnik et al, 2022), hasta el genético (Díaz Torres, 2022), el teletrabajo (Roncal, 2021) o la educación digital (Jarquín y Díez, 2022). ...
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Los dispositivos digitales, con el desarrollo del capitalismo algorítmico, han irrumpido en todas las esferas de la vida, trayendo consigo la propagación de un objetivo fundamental: modular la existencia de los sujetos a través de un despliegue algorítmico que tendrá por fin el conocer de forma pormenorizada a los usuarios a partir de los datos que comparten en las plataformas virtuales, hasta unirse íntimamente con estos. En este contexto se instala Chat- GPT, reciente dispositivo digital que se configura como una máquina comunicacional sugestiva que induce, interpela, incide y, en definitiva, produce narrativas que se ajustan a las visiones hegemónicas de una época para que así el usuario las haga suyas y, por ende, las reproduzca.
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Deputy Editor‐in‐Chief, Prof Aris T. Papageorghiou, discusses the latest thinking in women’s health and highlights articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/march-editorial-2020
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With the arrival of new methods of genome editing, especially CRISPR/Cas 9, new perspectives on germline interventions have arisen. Supporters of germ line genome editing (GGE) claim that the procedure could be used as a means of disease prevention. As a possible life-saving therapy, it provides benefits that outweigh its risks. Opponents of GGE claim that the medical and societal risks, especially the use of GGE for genetic enhancement, are too high. In our paper, we analyze the risks and benefits of GGE. We show that the medical risk on an individual level might be reduced by further research in the near future so that they may be outweighed by the benefits. We also show that the societal risks of the procedure, i.e. genetic enhancement, are manageable by establishing a regulative framework before the GGE is implemented. Since the effects of modifying genes for the genepool of a given population are extremely difficult to model, the medical risks on the population level might be too high.
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Since its emergence in 2012, the genome editing technique known as CRISPR-Cas9 and its scientific use have rapidly expanded globally within a very short period of time. The technique consists of using an RNA guide molecule to bind to complementary DNA sequences, which simultaneously recruits the endonuclease Cas9 to introduce double-stranded breaks in the target DNA. The resulting double-stranded break is then repaired, allowing modification or removal of specific DNA bases. The technique has gained momentum in the laboratory because it is cheap, quick, and easy to use. Moreover, it is also being applied in vivo to generate more complex animal model systems. Such use of genome editing has proven to be highly effective and warrants a potential therapy for both genetic and non-genetic diseases. Although genome editing has the potential to be a transformative therapy for patients it is still in its infancy. Consequently, the legal and ethical frameworks are yet to be fully discussed and will be an increasingly important topic as the technology moves towards more contentious issues such as modification of the germline. Here, we review a number of scientific and ethical issues which may potentially influence the development of both the technology and its use in the clinical setting.
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Purpose of review: To review the recent ethical, legal, and social issues surrounding human reproduction involving germline genome editing. Recent findings: Genome editing techniques, such as CRISPR/Cas9, have facilitated genetic modification in human embryos. The most likely purpose of germline genome editing is the prevention of serious genetic disease in offspring. However, complex issues still remain, including irremediable risks to fetuses and future generations, the role of women, the availability of alternatives, long-term follow-up, health insurance coverage, misuse for human enhancement, and the potential effects on adoption. Further discussions, a broad consensus, and appropriate regulations are required before human germline genome editing is introduced into the global society. Summary: Before germline genome editing is used for disease prevention, a broad consensus must be formed by carefully discussing its ethical, legal, and social issues.
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Background: The avalanche of commentaries on CRISPR-Cas9 technology, a bacterial immune system modified to recognize any short DNA sequence, cut it out, and insert a new one, has rekindled hopes for gene therapy and other applications and raised criticisms of engineering genes in future generations. Sources of data: This discussion draws on articles that emphasize ethics, identified partly through PubMed and Google, 2014-2016. Areas of agreement: CRISPR-Cas9 has taken the pace and prospects for genetic discovery and applications to a high level, stoking anticipation for somatic gene engineering to help patients. We support a moratorium on germ line manipulation. Areas of controversy: We place increased emphasis on the principle of solidarity and the public good. The genetic bases of some diseases are not thoroughly addressable with CRISPR-Cas9. We see no new ethical issues, compared with gene therapy and genetic engineering in general, apart from the explosive rate of findings. Other controversies include eugenics, patentability and unrealistic expectations of professionals and the public. Growing points: Biggest issues are the void of research on human germ cell biology, the appropriate routes for oversight and transparency, and the scientific and ethical areas of reproductive medicine. Areas timely for developing research: The principle of genomic solidarity and priority on public good should be a lens for bringing clarity to CRISPR debates. The valid claim of genetic exceptionalism supports restraint on experimentation in human germ cells, given the trans-generational dangers and the knowledge gap in germ cell biology.
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Although germline editing has been the subject of debate ever since the 1980s, it tended to be based rather on speculative assumptions until April 2015, when CRISPR/Cas9 technology was used to modify human embryos for the first time. This article combines knowledge about the technical and scientific state of the art, economic considerations, the legal framework and aspects of clinical reality. A scenario will be elaborated as a means of identifying key ethical implications of CRISPR/Cas9 genome editing in humans and possible ways of dealing with them. Unlike most other discussions of CRISPR/Cas9 germline editing, which are generally based on deontological arguments, the focus in this case will be on a consequentialistic argument against certain applications of germline and somatic editing that takes not only the potential benefits and risks but also socioeconomic issues into consideration. The practical need for an indication catalogue, guidelines for clinical trials, and for funding of basic research will be pointed out. It will be argued that this need for regulatory action and discussion does not stem primarily from the fact that CRISPR/Cas9 germline editing is revolutionary in terms of its ethical implications and potential for human therapy, although this is the prevailing view in the current discussion. Understanding the value and interest dependency of arguments put forward by different stakeholders and learning from past debates related to similar technologies might prove a fruitful method of reaching judgments and decisions that come closer to a consensus upon which society as a whole can agree - which after all should be the true goal of an ethical debate and of bioethics.
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This paper, which is based on an extensive analysis of the literature, gives a brief overview of the main ways in which solidarity has been employed in bioethical writings in the last two decades. As the vagueness of the term has been one of the main targets of critique, we propose a new approach to defining solidarity, identifying it primarily as a practice enacted at the interpersonal, communal, and contractual/legal levels. Our three-tier model of solidarity can also help to explain the way in which crises of solidarity can occur, notably when formal solidaristic arrangements continue to exist despite 'lower tiers' of solidarity practices at inter-personal and communal levels having 'broken away'. We hope that this contribution to the growing debate on the potential for the value of solidarity to help tackle issues in bioethics and beyond, will stimulate further discussion involving both conceptual and empirically informed perspectives.
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Bioethical work on solidarity has yielded an array of divergent conceptions. But what do these accounts add to normative bioethics? What is solidarity’s distinctive social normative role? Prainsack and Buyx suggest that solidarity be understood as the ‘putty’ of justice. I argue here that the putty metaphor is deeply insightful and—when spelled out in detail—successfully explicates solidarity’s social normative function. Unfortunately, Prainsack and Buyx’s own account cannot play this role. I propose instead that the putty metaphor supports a conception of solidarity as equity. This proposal enables us to answer whether and when we should act in solidarity, and with whom, while also capturing the putty metaphor and hence answering a basic question: what is solidarity for?
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Advances in genome editing techniques have generated renewed interest in the ethical implications of genetic modification. In this article, we review the recent literature and discuss in detail ethical issues pertaining to the application of this technology to five areas; human embryo research, organoid research, the prospect of genetically modified babies, mitochondrial replacement therapy and the creation of chimeric organisms. We point to a central issue which cuts through these different areas: the need to clearly frame how using the technology provides benefit that cannot be met by other means. Failure to provide reasonable justification, and address how risks-if any-will be mitigated, is likely to erode public trust and undermine progress in medical research and its clinical translation.