对被忽视疾病的药物开发:一个缺陷的市场和公共卫生政策的失败
Patrice Trouiller1, Piero Olliaro, Els Torreele
1Centre Hospitalier Universitaire, BP 217, 38043 Grenoble cedex 9, France. PTrouiller@chu-grenoble.fr
Lancet (London, England)
|July 2, 2002
概括
由于利低,制药公司忽视了发展中国家的疾病. 对于被忽视的热带疾病和结核病药物开发,需要新的战略和国际政策.
科学领域:
- 制药研发领域的研发工作.
- 全球健康 全球健康
- 药物发现 药物发现 药物发现
背景情况:
- 传染病不成比例地影响发展中国家贫困人口,导致严重的死亡率和发病率.
- 对于这些被忽视的疾病,在开发有效,安全和负担得起的药品方面存在关键差距.
- 制药行业专注于利丰厚的市场,导致全球南方普遍存在的疾病被忽视.
研究的目的:
- 分析25年来制药研发 (R&D) 的趋势.
- 审查现有的公共和私人倡议,以解决被忽视疾病的研发不平衡问题.
- 确定必要的战略,以实现对影响贫困人口的疾病的可持续药物开发.
主要方法:
- 在Medline和监管数据库 (美国FDA,欧洲EMA) 的搜索.
- 对1975年至1999年期间销售的新化学实体 (NCE) 的分析.
- 审查已发表的关于公共和私人倡议的研究被忽视的疾病.
主要成果:
- 在市场上销售的1393种NCE中 (1975-1999) 只有16种针对热带疾病和结核病.
- 与中枢神经系统或癌症药物相比,治疗被忽视疾病的药物进入市场的可能性要低13倍.
- 工业界将高的研发成本和低的回报列为投资被忽视疾病的障碍.
结论:
- 目前的研发模式不足以应对主要影响贫困人口的疾病.
- 公私伙伴关系和激励措施尚未完全克服市场限制.
- 可持续的解决方案需要对被忽视的疾病制定国际制药政策,探索私营部门的义务,并促进公共非营利性研发.
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