Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials.
J Med Ethics
; 44(11): 761-767, 2018 11.
Article
em En
| MEDLINE
| ID: mdl-29982174
ABSTRACT
Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or 'preapproval', access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients' best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.
Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Drogas em Investigação
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Indústria Farmacêutica
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Ensaios de Uso Compassivo
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Tomada de Decisão Clínica
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Relações Interprofissionais
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
J Med Ethics
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Estados Unidos