Urgent TB Drug Development Called For By Doctors Without Borders

Main Category: Tuberculosis
Also Included In: Infectious Diseases / Bacteria / Viruses;  MRSA / Drug Resistance;  Clinical Trials / Drug Trials
Article Date: 06 Nov 2007 - 7:00 PDT

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A new approach to overcoming the bottlenecks in the search for TB drugs

Early stage drug discovery is a key bottleneck in the pipeline to find novel drugs for tuberculosis, say Martina Casenghi (MSF) and colleagues.

The lack of candidate compounds is "cause for alarm," they say, given the global emergence of strains of TB that are resistant to current TB drugs.

The authors argue that the few drug companies engaged in TB drug development are risk averse, generally embarking on drug development only when given evidence of rigorously validated targets and lead compounds that inhibit them. As a result, it has fallen largely to academia to undertake early stage drug discovery.

Alternative approaches are needed, say Casenghi and colleagues, to stimulate research and development of TB drugs. They lay out one such approach, which they call "open-access drug discovery entities," in which academia and industry collaborate and share their results at the earliest opportunity. "One way to ensure that priority medical needs are met while providing economic incentives," say the authors, "is to register resulting patents under a patent track that rewards products based on the impact they have in reducing the global burden of disease."

Citation: Casenghi M, Cole ST, Nathan CF (2007) New approaches to filling the gap in tuberculosis drug discovery. PLoS Med 4(11): e293.

Link to the published article.

Contact:
Martina Casenghi
Médecins Sans Frontières
Access to medicines
rue de Lausanne 78
Geneva 21, 1211
Switzerland

Massive expansion of clinical trials capacity is urgently needed

An urgent and massive expansion of clinical trials capacity is needed to carry out vital research to accelerate the development and evaluation of new TB drugs, say Unni Karunakara (MSF) and colleagues.

"Trials are urgently needed," they say, "to find regimens that are shorter, less toxic, and effective against multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDRTB)." Trials are also needed, they argue, to find new TB treatment regimens for children, for those with TB and HIV co-infection, and those with TB occurring outside the lungs (extra-pulmonary TB).

Unfortunately, say the authors, only about US $20-30 million was spent in 2005 around the world for TB clinical trials. The authors call for funding of at least US $300-500 million annually for a TB trials agenda.

Direct investment is also needed, they say, in the infrastructure required to conduct trials.

Citation: Schluger N, Karunakara U, Lienhardt C, Nyirenda T, Chaisson R (2007) Building clinical trials capacity for tuberculosis drugs in high-burden countries. PLoS Med 4(11): e302.

Link to the published article.

Contact:
Unni Karunakara
Medecins Sans Frontieres
Plantage Middenlaan 14 108 DD
Amsterdam, 1018 DD
Netherlands

The time is right for trials of multidrug-resistant TB therapy

Drug-resistant TB strains may account for 10% of the 8 million new cases of TB that occur each year, say Carole Mitnick (Harvard Medical School, Boston, USA) and colleagues. Increasing concern about resistance has redoubled interest in strategies to control drug-resistant TB, they say, especially in settings of high HIV prevalence.

Current treatments for MDR-TB last between 18 and 24 months, adverse effects are common, and many patients cannot be cured.

However, the time is now right, say Mitnick and colleagues, to conduct randomized clinical trials of new regimens for treating MDR-TB. For a start, MDR-TB treatment programs have expanded dramatically: 40 programs in resource-limited settings are managing treatment for nearly 30,000 patients. These treatment programs provide the settings in which trials can be implemented. In addition, for the first time in 30 years, several new drug classes hold promise for MDR-TB treatment.

"Four elements are needed," say the authors, "to make MDR-TB treatment trials a reality: money; additional work on the drug pipeline; rigorous, interdisciplinary preclinical work on individual agents and regimens; and an understanding that TB clinical trials need not be a zero-sum endeavor."

Citation: Mitnick CD, Castro KG, Harrington M, Sacks LV, Burman W (2007) Randomized trials to optimize treatment of multidrug-resistant tuberculosis. PLoS Med 4(11): e292.

Link to the published article.

Contact:
Carole Mitnick
Harvard Medical School
Department of Social Medicine
643 Huntington Ave., 4th Floor
Boston, MA 02115
United States of America

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Article adapted by Medical News Today from original press release.
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Source: Josh Eveleth
Public Library of Science