Abstract
IntroductionPrior research on neglected disease drug development suggested inadequate funding was responsible for relatively few new approvals. In response, significantly more resources have been allocated towards development of drugs targeting neglected diseases. Our objective was to reassess drug development between1975 and 1999, evaluate progress in neglected disease drug development since 2000, and explain how increased numbers of approvals are a necessary but insufficient condition to improving access.MethodsTo assess numbers of approvals targeting neglected diseases, we employed two distinct methodologies: First, to revisit numbers published in Trouiller et al. (2002) we used their method to count marketed new chemical entities (NCEs) between 1975 and 1999. Second, using the G-Finder report as a benchmark, we identified which diseases are currently considered “neglected” to tally approvals in the 1975–1999 and 2000–2009 periods. Searching PharmaProjects and IMS R&D Focus databases as well as websites from numerous drug regulatory agencies, we identified new drug approvals and indications. Also, we examined the World Health Organization's (WHO) Essential Drug List (EDL) to see which drugs and indications were on the list.FindingsUpon recount, using Trouiller et al. methodology, we found that between 1975 and 1999 more NCEs (n = 32) targeting tropical diseases and tuberculosis were approved than reported in Trouiller et al. (n = 16). Using the G-Finder method of defining neglected diseases, we found 46 new drug approvals between 1975 and 1999. WHO included 85% of these drugs on the EDL. In the period 2000 to May 2009, despite much greater funding, only 26 new drugs and vaccines for neglected diseases were marketed. Of these, WHO placed 50% on the EDL.ConclusionsProduct approvals for neglected diseases have increased, though progress has been uneven, with malaria appearing to benefit most in the short run from increased funding, while less success has been booked in other disease categories. Uneven progress suggests funding could be better targeted, particularly with regard to neglected diseases that have hitherto received scant attention. In addition, policymakers should focus on other aspects related to access. Besides drug development, there are the issues of EDL listing, architecture, availability, affordability, and adoption.
Highlights
Prior research on neglected disease drug development suggested inadequate funding was responsible for relatively few new approvals
In a widely cited 2002 study, Trouiller et al reported that of 1393 new chemical entities (NCEs) marketed between 1975 and 1999, only 16 targeted ‘‘tropical diseases’’ and tuberculosis.[3]
Trouiller et al found that in 1999 less than $70 million was invested in drug research and development for malaria, tuberculosis, leishmaniasis, and African trypanosomias combined.[4]Their study galvanized thought leaders to proclaim the necessity of greater investment in neglected disease drug development
Summary
Prior research on neglected disease drug development suggested inadequate funding was responsible for relatively few new approvals. In a widely cited 2002 study, Trouiller et al reported that of 1393 new chemical entities (NCEs) marketed between 1975 and 1999, only 16 targeted ‘‘tropical diseases’’ and tuberculosis.[3] Trouiller et al found that in 1999 less than $70 million was invested in drug research and development for malaria, tuberculosis, leishmaniasis, and African trypanosomias combined.[4]Their study galvanized thought leaders to proclaim the necessity of greater investment in neglected disease drug development As such it served as a clarion call to action for governments, non-profit foundations, private-public partnerships, and the private industry to earmark more resources to battle this public health problem
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