Powered by OpenAIRE graph
Found an issue? Give us feedback
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/ Cuadernos de Bioétic...arrow_drop_down
image/svg+xml art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos Open Access logo, converted into svg, designed by PLoS. This version with transparent background. http://commons.wikimedia.org/wiki/File:Open_Access_logo_PLoS_white.svg art designer at PLoS, modified by Wikipedia users Nina, Beao, JakobVoss, and AnonMoos http://www.plos.org/
versions View all 1 versions
addClaim

[Use of ataluren in Spain: administrative incoherences and ethical implications].

Authors: Pilar, Pacheco López; María Antonia, Meroño Saura; Ana, Aranda García;

[Use of ataluren in Spain: administrative incoherences and ethical implications].

Abstract

Duchenne muscular dystrophy is a rare genetic disease with only ataluren like pharmaceutical treatment available. This drug received a conditional authorization by the European Medicines Agency (EMA) in 2014, meaning that it was commercially available while waiting for more solid results that demonstrate the efficacy and safety. Currently, the authorization still maintains the ″conditional″ modality, and the actual health benefits of the drug still remain unclear. In Spain, ataluren is not financed by the National Health System. The decision of non-financing has generated a heated debate, especially because in those patients who se treatment were started prior to the non-financing decision the drug has continued being funded. This controversial situation encompasses complex aspects of pharmaceutical and health management related to scientific evidence, the motivations of regulatory agencies and the pharmaceutical industry in the processes of drug investigation and authorization. Furthermore, as the center of the debate, some pillars of bioethics such as justice and equity, as well as certain legal principles, such as the protection of minors, are involved.

Keywords

Muscular Dystrophy, Duchenne, Oxadiazoles, Social Justice, Spain, Humans

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
gold