22 December 2015 — Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes the U.S. government's "Action Plan" to scale-up drug-resistant tuberculosis (DR-TB) treatment in top-burden countries and accelerate research and development for better therapies and diagnostics.
The World Health Organization (WHO) estimates that barely one quarter of people with multidrug-resistant tuberculosis (MDR-TB) were put on treatment in 2014, and only about half of these patients successfully complete treatment. Among people with an even more severe form of the disease, extensively drug-resistant TB (XDR–TB), the treatment success rate is just one in four.
Sharonann Lynch, HIV & Tuberculosis policy adviser for MSF's Access Campaign, gave the following response to the U.S. government's announcement:"The success of the U.S. government’s plan on DR-TB should be measured by whether it manages to increase access to bedaquiline and delamanid, the first new drugs to treat TB in half a century. Today, only 2 percent of people who could benefit from these two new medicines have access to them.
"Furthermore, more funding and a fundamental change to research and development systems are needed to develop new regime therapies that are easier for patients to take, affordable and that can improve today’s abysmal low cure rates (50% for MDR-TB and 26% for XDR-TB). Current treatment for DR-TB can involve people having to take almost 15,000 pills for two years, plus a daily painful injection for eight months. Side effects caused by the drugs are horrendous, ranging from persistent nausea to deafness and psychosis.
"This plan can help reverse the historic neglect of research and development (R&D) for TB. New and more appropriate incentive mechanisms are needed to both accelerate R&D and ensure collaboration and affordability. These include reforming current U.S. incentives mechanisms like the FDA Priority Review Voucher as well as the creation of new innovation frameworks as MSF and partners are proposing in the 3P TB proposal with ‘push’ funding through grants, ‘pull’ funding through prizes, and ‘pooling’ of data and intellectual property to ensure open collaborative research and to ensure competitive and affordable production of the final products.
"Finally, this plan will need to be fully funded if it is to have any impact and meet any of its targets. More money needs to be spent on TB – we can’t see a continuation of flat funding TB year after year.”
More information: Access to bedaquiline (marketed by Janssen) and delamanid (marketed by Otsuka) is severely limited. Less than 3,000 people globally have received bedaquiline as of November 2015. Only about 100 people globally have received delamanid through compassionate use programs.
See also:
The 3P Project: A new approach to developing better treatments for TB Open Letter to the U.S. Senate HELP
Committee Leadership: Suggestions to Fix the FDA PRV for Neglected Diseases
MSF has been providing TB care to patients across the world for over three decades, often working alongside national health authorities to treat patients in a wide variety of settings, including conflict zones, urban slums, prisons, refugee camps, and rural areas. MSF's first programs to treat DR-TB opened in 1999, and the organization is now one of the largest non-governmental providers of DR-TB care in the world. In 2014, MSF provided TB treatment in more than two dozen countries to 21,500 patients, including 1,800 patients treated for DR-TB.