Treatments for tuberculosis
The US Food and Drug Administration plays an important role in facilitating the development of new vaccines and drugs to protect
against global infectious diseases. Its role may expand under Commissioner Margaret Hamburg, who built a strong record in
public health and TB-control efforts as head of New York City's public-health department in the 1990s. That experience will
help FDA encourage research on new TB treatments and counter a resurgence in multidrug-resistant and extensively drug-resistant
In Washington this month
The good news is that new TB-drug development and international collaborations are taking place. The trend demands clearer
FDA guidelines on TB-drug testing. Current therapies are decades old, involve lengthy treatment courses, result in poor compliance,
and generate resistant TB strains.
An FDA advisory-committee meeting in June supported establishing a research pathway with early endpoints for drugs to treat
multidrug-resistant TB. The panel agreed that reduced bacterial count in sputum culture, followed by confirmatory trials to
document low relapse rates, could accelerate the research and development (R&D) process, an approach that could be useful
for the new compound being developed by Johnson & Johnson's (New Brunswick, NJ) Tibotec subsidiary with support from the Global
Alliance for TB Drug Development (TB Alliance).
FDA followed up with a two-day workshop in July that delved into clinical-trial design challenges for drug-susceptible TB.
The panel evaluated noninferiority study designs, combination-therapy regimens, problems of missing data, and early study
endpoints. TB Alliance President Melvin Spigelman emphasized the importance of testing new combination-drug regimens that
combat resistance and lead to individualized therapy. Gail Cassell, vice-president of Eli Lilly (Indianapolis), advocated
"boldness in clinical-trial design," along with better postapproval adverse-event monitoring.