Research Roundup: What we’re reading this week

In this guest post, Dr. Mel Spigelman—president and CEO of the TB Alliance—writes about advancing the first-ever drug regimen designed to treat both drug-sensitive and some forms of multi-drug resistant tuberculosis (TB) to a global Phase III clinical trial. Receiving treatment for multi-drug resistant TB (MDR-TB), which afflicts nearly half a million people around the world, is one of the harshest experiences modern medicine has to offer. Treatment lasts up to two years, with more than 14,000 pills and daily injections for the first six month of treatment. Side effects range from nausea to permanent hearing loss and worse. Compounding matters is that this treatment only works about half the time, and is even more challenging to administer in patients also receiving therapy for HIV and AIDS. While this sounds extremely bleak, those who experience this care are fortunate. The above situation represents the best MDR-TB care available. Many TB and MDR-TB patients are unable to receive an accurate diagnosis. These patients have an even harder time with drug-resistant TB, and many ultimately die. Based on positive results from earlier clinical studies, TB Alliance is advancing the first-ever drug regimen designed to treat both drug-sensitive and some forms of multi-drug resistant tuberculosis (TB) to a global Phase III clinical trial. Photo: PATH/Gabe Bienczycki Today, however, there is hope. Better yet, those infected with drug-sensitive (or “normal”) TB—eight million people around the world—can also enjoy this hope. By the end of 2014, a new global clinical trial will begin testing the first ever drug regimen designed to treat both versions of TB in 50 sites on four continents. The trial, known as STAND (Shortening Treatments by Advancing Novel Drugs), will test a novel drug combination, or regimen. Traditionally, individual drugs were developed, then added or substituted into the existing treatment, enabling incremental progress. But the STAND trial, which tests a regimen called PaMZ, represents an opportunity to transform treatment. PaMZ promises to shrink the length of time patients are treated by more than a year for some forms of MDR-TB. As a completely oral regimen, it would eliminate injections and reduce the extraordinary demands that a TB diagnosis places on both patients and healthcare providers. Additionally, this regimen was developed for compatibility with commonly used antiretroviral drugs, which would improve patient care for the millions infected with both TB and HIV. With such a vastly reduced amount of medicine, PaMZ is expected to reduce the cost of MDR-TB treatment by over 90 percent in some countries. In the case of drug-sensitive TB, the regimen projects to be competitive with current treatment. Such cheaper, faster, simpler cures would provide amazing benefits not just to patients but for communities and national health care systems overly stressed from such an intractable disease. This regimen has been advanced to date thanks to the commitment of a series of partners including the Bill & Melinda Gates Foundation, the UK Department for International Development the Australian Department for Foreign Affairs and Trade, the US Agency for International Development, Irish Aid, and the Directorate-General for International Cooperation in the Netherlands. Now, as preparations for the STAND trial begin, we call for continuing as well as new support to bring this promising treatment through its final hurdle before it can be made available to the millions in need. TB has afflicted mankind since the time of the Pharaohs. The current first-line treatment for TB was assembled almost half a century ago; while the disease has continued to evolve, new medicines have been few and far between. TB is second only to HIV as the leading infectious killer of adults worldwide, and is also the leading infectious cause of death among people with HIV and AIDS. Hope has been a scarce commodity for TB patients today, especially those who have MDR-TB. We owe it to the millions of these patients—and the millions more to come—to move the STAND trial to the finish line. In this day and age, taking medicine and getting cured should be an easy sprint, not a gruesome marathon. To learn more about the STAND trial, click here.

In this guest post, Heather Ignatius—senior policy and advocacy officer at PATH—writes about the new Global Development Lab at the US Agency for International Development (USAID). The Lab was formally launched at an event in New York City earlier this month by former Secretary of State Hillary Clinton and USAID Administrator Rajiv Shah. Last week I had the opportunity to attend a briefing on the new USAID Global Development Lab. The Lab—as it’s now referred to—aims to invent, test, and apply dramatically more cost efficient and impactful solutions to men, women, and children so they can lift themselves out of extreme poverty. It will collaborate with many stakeholders—including entrepreneurs, the private sector, nongovernmental organizations (NGOs), universities, and science and research institutions—to incorporate science, technology, innovation, and partnerships as a means to solve development challenges and improve the lives of millions of people in a short time span. The launch of the Lab brings the tremendous science, technology, and innovation credentials America has to offer to the practice of development. This effort will embed the principles of partnership and innovation into USAID’s DNA, allowing the agency to become a cutting-edge leader in development. The Lab aims to invent, test, and apply dramatically more cost efficient and impactful solutions to men, women, and children so they can lift themselves out of extreme poverty. Photo: PATH/Gabe Bienczycki The Lab will bring together a diverse set of partners to “discover, incubate, and scale breakthrough development innovations” in many of the sectors USAID works in, including health. There are eight stated areas of focus for the Lab: Food Security and Nutrition; Modernizing Food Assistance; Ending Preventable Child and Maternal Deaths; Energy Access; Water Solutions; Child Literacy; Financial Inclusion; Rights, Participation and Accountability; and Humanitarian Response. Some of the agency’s key research programs, including the PEER Health Program and the Development Innovation Ventures initiative, will be housed within the Lab. It is encouraging to hear that health will be one of the issues areas the Lab takes up, and many of the innovations highlighted by the Lab are in the health arena—including products developed through USAID’s successful Saving Lives at Birth grand challenge. However, it should be noted that the majority of USAID’s investments in global health research and development (R&D) currently sit outside the Lab’s structure. As it moves from concept into operations, it will be important for USAID to ensure that the Lab is synergistic with the agency’s other global health R&D efforts. It will also be important to maintain investment for innovations that sit outside the Lab. As the bedrock of many global health successes, R&D is critical to developing the next generation of health tools that can prevent, treat, and one day halt existing and emerging global health threats. For more than 25 years, PATH has worked with USAID to identify global health needs and adapt, design, develop, and advance appropriate and affordable health technology solutions. By serving as the bridging agent between the public and private sectors, PATH has helped advance more than 80 technologies tailored to low-resources settings with more than 100 private-sector collaborators that have matched federal dollars two to one. At the Lab’s launch, USAID’s leaders issued an open invitation to partners to help shape the Lab’s formation. We look forward to working with USAID to realize the full potential of the Lab to accelerate innovation for health. It will not be possible to meet tomorrow’s development challenges without innovation. New and effective health solutions must be part of that equation.