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[制药巨头附属研究人员对拉丁美洲临床试验伦理与质量的影响]

[The impact of researchers loyal to Big Pharma on the ethics and quality of clinical trials in Latin America].

作者信息

Ugalde Antonio, Homedes Núria

机构信息

Departamento de Sociología, University of Texas at Austin, EE.UU.

Departamento de Salud Internacional, Georgetown University, Washington DC, EE.UU.

出版信息

Salud Colect. 2015 Mar;11(1):67-86. doi: 10.18294/sc.2015.416.

Abstract

This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.

摘要

本文阐述了创新制药公司在以可观股息回报股东方面所面临的困难。这一问题是重磅炸弹药物专利到期以及公司在将新的重磅炸弹药物推向市场时遇到困难的结果。公司找到的解决方案之一是加快临床试验的实施,以加速新药的商业化。这样做会延长它们能够以垄断价格销售药物的时间。因此,我们将讨论创新制药公司如何缩短在拉丁美洲的临床试验实施时间,以及这些行动对所收集数据的质量、实验对象人权的保护以及对国际宣言中批准的伦理原则的遵守情况所产生的影响。

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