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First new tuberculosis drug in fifty years risks being squandered

Without a new approach to developing and pricing new tuberculosis medicines, the global tuberculousis (TB) response will be unable to deliver the new treatment combinations needed to close the deadly treatment gap for drug-resistant tuberculosis (DR-TB), warned the international medical humanitarian group Médecins Sans Frontières/Doctors Without Borders (MSF) at the Union World Conference on Lung Health in Paris.

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South Africa.

No room for complacency 
Swaziland 2013 © Sven Torfinn

In December 2012, a 50 year drought in TB drug research and development (R&D) came to an end with the approval in the U.S. of bedaquiline, a novel TB medicine marketed by Janssen, a subsidiary of Johnson & Johnson (J&J)

“This is a significant milestone for clinicians and patients, but there is no room for complacency or celebration yet.

The new drug is obviously a boon, but what we really need are entire new combinations of drugs to treat DR-TB”, said Dr. Cathy Hewison, TB advisor for Médecins Sans Frontières.

If we are unable to offer patients an entirely new, tolerable and more effective regimen in the coming years, the opportunity to radically improve DR-TB treatment will be squandered.”

Bringing TB drugs to market

The U.S. Food and Drug Administration fast-tracked the approval of bedaquiline, the World Health Organization (WHO) issued rapid guidelines for its use, and J&J has pushed for registration fairly widely; these are positive signals that the TB context is ready to respond quickly to new drugs.

>But achieving the goal of entirely new regimens requires a more fundamental change in the way TB drugs are researched and brought to market.

“We need much more collaborative research early on, instead of companies operating in silos, and this will require a massive commitment from the global research community, as well as a significant injection of funds at a time when the global investment for TB R&D is actually declining”,said Sharonann Lynch, policy advisor for the Médecins Sans Frontières Access Campaign.

WHO estimates that fewer than 20% of the world’s drug-resistant TB cases are diagnosed and treated.  Because treatment is long, arduous, expensive and poorly effective, with global cure rates stagnating around 50%, scale-up of DR-TB diagnosis and treatment is extremely difficult.

Affected countries should scale up efforts to diagnose and treat DR-TB today, so that robust programmes are in place to ensure responsible and effective use of new treatment combinations once they are available. 

Affordable treatment

Tajikistan 2013 © Wendy Marijnissen

To achieve this, countries will need support, so a fully financed Global Fund to Fight AIDS, Tuberculosis and Malaria will be critical.

“We also need to be preparing the ground so that new treatments are affordable. J&J’s pricing structure for bedaquiline leaves middle-income countries, some of which are among the hardest hit by DR-TB, paying US$3,000 for a six-month course”, said Sharonann Lynch.

“That’s for just one drug - bear in mind several drugs are needed for effective treatment. If the new treatment combinations of the future cost in excess of several thousand dollars even in the poorest countries, as they do today, how on earth will countries be able to increase access and expand coverage?”

Médecins Sans Frontières is one of the largest non-governmental organisations providing DR-TB care. In 2012, Médecins Sans Frontières treated 29,000 patients for TB in 30 countries, and 1,780 patients for DR-TB in 18 countries. Médecins Sans Frontières and the International Union Against Tuberculosis and Lung Disease today released DR-TB Drugs Under the Microscope, a report on the prices, sources, access environment and R&D landscape for DR-TB medicines. The report is available here.