Saturday, October 16, 2010

Why hasn’t there been a new TB drug in over 30 years?

Tuberculosis infects one third of the world’s population, kills two million people each year, and costs the global economy $16 billion annually.

1.With the vast majority of TB patients concentrated in the world's poorest countries, there has traditionally been little incentive for the private sector to invest in the major research and development costs necessary for new TB medicines. Until recently, innovative research and development for TB drugs was at a virtual standstill, and had been since the 1960s.

2.Today’s four-drug combination, taken ideally under daily monitoring, is burdensome for patients and care providers alike. Poor adherence and prescribing practices have led to the emergence of multi- and extensively drug resistant strains of TB (MDR-TB and XDR-TB) that increasingly defy current medicines and are spreading throughout many regions of the globe.

3. Each country has its own regulatory agency and process, and therefore its own rules and requirements for approving and registering new treatments. Sponsors clarity on local regulatory requirements (particularly in high-burden settings) as a major impediment to the rapidity of initiating clinical trials. Because there has not been a TB drug registration trial since the 1960s, there is little to no experience in conducting and monitoring these type of studies in the TB field.

4. Breakdown of public health services -- When TB cases started to decrease, public policymakers concluded that TB was no longer a threat to public health. Funding was reduced, research stopped, health-care workers were not trained about TB, and services to make sure people took their medicine stopped.

I'll try to look for more points. :P

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