Tuberculosis Experts Outline Proposals To Speed Up Drug Development

Proposals to accelerate the development of tuberculosis (TB) drugs were outlined today at the conclusion of a two-day symposium titled "No Time to Wait," convened in New York this week by the international medical humanitarian organization Doctors Without Borders/MГ(c)decins Sans Frontires (MSF) with the support of Howard P. Milstein and Weill Cornell Medical College's Abby and Howard P. Milstein Program in Chemical Biology. The symposium brought together more than 100 TB specialists, drug developers and regulators, policy makers, donors and activists to outline practical proposals to fill the gaps in TB drug research and development (R&D).

"We are failing people with TB," said Dr. Tido von Schoen-Angerer, Director of MSF's Campaign for Access to Essential Medicines. "Diagnosing and treating TB is one of the greatest challenges facing health care providers around the world. Things are going from bad to worse with multi-drug resistant TB and even extensively drug resistant (XDR) TB, particularly in settings with high HIV prevalence. The urgency for new tools could not be greater - there is no time to wait."

TB kills nearly two million people per year, primarily because of inadequate diagnostic and treatment tools. While roughly one drug for HIV has been developed each year since the start of the epidemic 25 years ago, the latest novel TB drug in today's standard therapy was developed in the 1960s. Basic science is not being translated into new TB drugs needed to improve treatment, according to an MSF analysis of the TB drug pipeline. There are not enough promising drugs in the pipeline and serious funding gaps prevent the development of candidate drug compounds through to clinical trials.

Resistance to TB drugs is growing at a rapid pace, with 450,000 new cases of drug-resistant TB detected each year. The recent detection of hundreds of cases of XDR-TB, which is extremely difficult and sometimes impossible to treat, adds further urgency to the situation. TB remains the main killer of people with HIV, in large part because existing TB drugs and tests are poorly adapted for use in people with HIV/AIDS.

"In TB research, there needs to be a convergence of innovation, incentive, and access," said Dr. Carl Nathan, Rees Pritchett Professor of Microbiology and Chairman of Microbiology and Immunology at Weill Cornell Medical College. "We need to see openness, leadership and collaboration among all TB actors."

Experts attending the symposium emphasized several actions that urgently need to be taken to improve the situation:

1. Drastically increase funding of TB R&D
2. Accelerate drug discovery
3. Expand clinical trial capacity and speed up clinical development
4. Commit to global TB R&D leadership
5. Support new approaches to R&D, such as a global R&D framework

"We need increased clinical trial capacity, fast-tracked clinical trials, and criteria for compassionate use of important candidate drugs," said Dr. von Schoen-Angerer. "To make any real difference, we need to see a dramatic increase in funding and political will."

The symposium emphasized a need to build a global TB R&D movement, as was critical to the advancements in HIV drug development. Strong political leadership is required to improve collaboration between scientists, drug developers, care providers, and affected individuals. Symposium participants agreed on the need for a massive increase in funding by governments for TB R&D, as current TB drug discovery initiatives are insufficient. Participants voiced support for an effort launched by governments at the World Health Assembly in May 2006 to examine alternative ways to prioritize and finance health-needs-driven R&D.

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