Drug development for neglected diseases: a deficient market and a public-health policy failure
Drug development for neglected diseases: a deficient market and a public-health policy failure
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DOI：
10.1016/s0140-6736(02)09096-7
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发表时间：
2002-06-22
期刊：
影响因子：
168.9
通讯作者：
Ford, N
中科院分区：
文献类型：
--
作者：
Trouiller, P;Olliaro, P;Ford, N
缺乏有效、安全和负担得起的药物来控制导致发展中国家贫困人口死亡率和发病率较高的传染病。我们分析了过去 25 年的药物研发成果，并回顾了当前旨在纠正研发不平衡的公共和私人举措，这种不平衡导致主要发生在发展中国家的疾病在很大程度上得不到解决。我们通过检索 Medline 以及美国食品药品监督管理局和欧洲药品评估机构的数据库来汇编数据，并通过对最近发表的研究进行分析来回顾当前的公共和私人举措。我们发现，1975 年至 1999 年间上市的 1393 种新化学实体中，只有 16 种用于治疗热带疾病和结核病。治疗中枢神经系统疾病或癌症的药物上市的可能性比治疗被忽视疾病的药物高 13 倍。制药行业认为，投资于低回报的被忽视疾病的研发成本太高、风险太大，公共和私人举措试图通过激励计划和公私合作伙伴关系来克服这一市场限制。缺乏针对“无利可图”传染病的药物研发将需要新的策略。如果不针对所有被忽视的疾病制定国际医药政策，就不可能为主要影响南方贫困人口的疾病带来可持续的解决方案。应探讨私营部门的研究义务，并促进公共部门的非营利性研究和开发能力。
There is a lack of effective, safe, and affordable pharmaceuticals to control Infectious diseases that cause high mortality and morbidity among poor people in the developing world. We analysed outcomes of pharmaceutical research and development over the past 25 years, and reviewed current public and private Initiatives aimed at correcting the Imbalance in research and development that leaves diseases that occur predominantly In the developing world largely unaddressed. We compiled data by searches of Medline and databases of the US Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products, and reviewed current public and private Initiatives through an analysis of recently published studies. We found that, of 1393 new chemical entities marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis. There Is a 13-fold greater chance of a drug being brought to market for central-nervous-system disorders or cancer than for a neglected disease. The pharmaceutical Industry argues that research and development is too costly and risky to invest in low-return neglected diseases, and public and private initiatives have tried to overcome this market limitation through incentive packages and public-private partnerships. The lack of drug research and development for "non-profitable" infectious diseases will require new strategies. No sustainable solution will result for diseases that predominantly affect poor people in the South without the establishment of an International pharmaceutical policy for all neglected diseases. Private-sector research obligations should be explored, and a public-sector not-for-profit research and development capacity promoted.