癌症研究用药物的人道供应困境

Dilemmas in the compassionate supply of investigational cancer drugs.

作者信息

Lewis J R R, Lipworth W, Kerridge I, Doran E

机构信息

Centre for Values, Ethics and Law in Medicine, School of Public Health, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.

出版信息

Intern Med J. 2014 Sep;44(9):841-5. doi: 10.1111/imj.12530.

DOI:10.1111/imj.12530

PMID:25201421

Abstract

In Australia, patients who want to access medicines that are not yet approved have only two options: to enroll in a clinical trial if they are eligible, or obtain their medicine through 'compassionate supply', which is provided at the discretion of the manufacturer. In this article, we explore ethical issues associated with the provision of oncology medicines that are still in development, either prior to regulatory approval or government reimbursement.

摘要

在澳大利亚，想要获取尚未获批药物的患者只有两种选择：如果符合条件，可参加临床试验；或者通过“同情用药供应”获得药物，这由制造商自行决定。在本文中，我们探讨了在监管批准或政府报销之前，提供仍在研发中的肿瘤药物所涉及的伦理问题。