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[热带病防治的研发现状:伪善、冷漠还是缺乏协调]

[Status of research and development for control of tropical diseases: hypocrisy, indifference or lack of coordination].

作者信息

Millet P

机构信息

Université Victor Segalen Bordeaux 2, Bordeaux Cedex, France.

出版信息

Med Trop (Mars). 2006 Dec;66(6):542-8.

Abstract

Tropical diseases neglected by the pharmaceutical industry usually involve developing countries. Neglected diseases can now be divided into two groups. The first includes the big three infections i.e., malaria, HIV/AIDS, and tuberculosis, that present strategic and political overtones. The second group includes a host of other fatal infections including worms, trypanosomiasis, and leishmaniasis. Fundamental research on neglected diseases has been highly productive, but there has been little success in transferring research findings to a pharmaceutical industry unwilling to take the risks associated with developing new drugs on its own. However several public-private initiatives have revived hopes of developing new products with growing involvement of industries in developing countries (India and Brazil) despite the high risks associated with fluctuating demand for medicines or funding shortages. To meet the need for testing new drugs, more clinical facilities and better patient recruitment will be needed in endemic countries. Although these new efforts to control neglected diseases are encouraging, there is now a need for coordination. Clinical research in developing countries must be organized in compliance with international principles of ethics. Testing must be aimed at validating fundamental data from industrialized countries. Appropriate incentives must be given to ensure that pharmaceutical companies use research findings for new product development. In this context, the time seems ripe for the establishment of an independent laboratory for technological innovation in neglected diseases. Such a facility could not only validate scientific data but also supervise the development of clinical applications from research data.

摘要

制药行业忽视的热带疾病通常涉及发展中国家。被忽视的疾病现在可分为两类。第一类包括三大感染疾病,即疟疾、艾滋病毒/艾滋病和结核病,这些疾病具有战略和政治色彩。第二类包括许多其他致命感染疾病,如蠕虫病、锥虫病和利什曼病。对被忽视疾病的基础研究成果丰硕,但在将研究结果转化为制药行业方面却鲜有成功,因为制药行业不愿自行承担开发新药的风险。然而,一些公私合作倡议重新燃起了开发新产品的希望,尽管存在药品需求波动或资金短缺等高风险,但发展中国家(印度和巴西)的行业参与度不断提高。为满足新药测试的需求,流行国家将需要更多的临床设施和更好的患者招募。尽管这些控制被忽视疾病的新努力令人鼓舞,但现在需要进行协调。发展中国家的临床研究必须按照国际伦理原则进行组织。测试必须旨在验证来自工业化国家的基础数据。必须给予适当的激励措施,以确保制药公司将研究结果用于新产品开发。在这种背景下,建立一个独立的被忽视疾病技术创新实验室的时机似乎已经成熟。这样一个设施不仅可以验证科学数据,还可以监督从研究数据到临床应用的开发过程。

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