Projan S J, Shlaes D M
Wyeth Research, Cambridge, MA 02140, USA.
Clin Microbiol Infect. 2004 Nov;10 Suppl 4:18-22. doi: 10.1111/j.1465-0691.2004.1006.x.
There has been a marked decline in the industrial research aimed at discovering novel antibacterial agents, including new drugs that target resistant organisms. While this decline may reflect past cyclical changes that often affect resource allocation at pharmaceutical companies, this decline is occurring at a time of increasing levels of antibacterial drug resistance and meagre pipelines of new agents that are active against them. There are multiple reasons for this decline, although few are unique to antibacterial drug discovery research. These include: lack of industry productivity, increasing size of clinical trials, increased generic competition and other pressures on drug pricing, a crowded and confused marketplace and industry consolidation. And while many (if not most) large companies and biotechs have exited the field or severely curtailed their research, others have made it a point to continue their efforts, citing both the unmet medical need and a large and apparently growing market. Despite the fact that some companies have remained engaged, the view here is that the current level of industrial effort is insufficient to sustain a healthy flow of new and better agents that are needed to counter the imminent threat of bacterial drug resistance. Therefore, a clear and urgent need for finding ways to improve the level and quality of industrial research in this area is apparent.
旨在发现新型抗菌剂(包括针对耐药菌的新药)的工业研究显著减少。虽然这种减少可能反映了过去常常影响制药公司资源分配的周期性变化,但这种减少发生在抗菌药物耐药性不断增加且对抗耐药菌的新型药物研发渠道匮乏之际。这种减少有多种原因,不过很少有原因是抗菌药物研发研究独有的。这些原因包括:行业生产力低下、临床试验规模扩大、仿制药竞争加剧以及其他药品定价压力、市场拥挤且混乱以及行业整合。尽管许多(如果不是大多数)大型公司和生物技术公司已退出该领域或大幅削减其研究,但其他公司则坚持继续努力,理由是存在未满足的医疗需求以及市场庞大且明显在增长。尽管一些公司仍在参与,但这里的观点是,当前的行业研发力度不足以维持对抗细菌耐药性迫在眉睫的威胁所需的新的、更好的药物的健康供应。因此,显然迫切需要找到提高该领域工业研究水平和质量的方法。