Breakthroughs Blog: Tuberculosis

In this guest post, Mandy Slutsker, senior project associate with the ACTION Partnership, writes about a new report that calls for increased efforts to fight tuberculosis among children worldwide. When Sipho* was just 18 months old, he began coughing and his feet began to swell. His mother Masia was sent home from a clinic near their home in Swaziland with medicine for a common cold, but his condition only worsened. Eventually, Sipho was diagnosed with a drug-resistant strain of tuberculosis (TB)—and so began an exhausting daily odyssey for him and Masia. Every day for six months, the pair traveled six kilometers so Sipho could receive a grueling treatment regimen of injections and crushed pills. Despite recent progress toward addressing childhood TB at the global level, children like Sipho are still misdiagnosed and subject to harsh treatment regimens meant for adults. Increased investments in research and development are needed to develop new child-friendly TB diagnostics, drugs, and vaccines. Photo credit: PATH As an advocate, I am thrilled to see childhood TB receive this attention—the issue gained recognition at international conferences, served as the theme of this year’s World TB Day, and is the subject of new guidelines from the World Health Organization. But I can’t forget TB takes the lives of 1.4 million people every year—and children remain largely unreached and uncounted. If we want to end TB as a killer of children, we need to do more than just talk. It’s time for action. Unfortunately, many barriers stand in our way—a lack of political will, inadequate funding for TB programs, and failure to invest in research and development (R&D) for child-friendly diagnostics, drugs, and vaccines. The standard microscope method available in many high-burden countries to diagnose TB largely isn’t effective in children, few child-friendly TB drugs exist, and the current TB vaccine fails to protect both children and adults against the most common form of the disease. How do we overcome these challenges? In my opinion, it all comes down to advocacy. It’s time for civil society, healthcare workers, governments, and the private sector to come together and ensure no child dies from this preventable and treatable disease. Civil society must mobilize to ensure governments and donors quickly invest additional resources in R&D to create new child-friendly diagnostics, drugs, and vaccines. In addition to R&D investments, we have to ensure new treatments—and better formulations of existing treatments—can reach children as quickly as possible. So donors, the private sector, and regulatory authorities must all work together to clarify the development pathway for childhood TB drugs. For too long we’ve worked in silos, not communicating with one another. We each have a role to play. We’ve built the momentum, now it’s time to act. Read the full brief, Children and Tuberculosis: From Neglect to Action, at Action.org and join the #kidsTB #putkids1st conversation on Twitter. *Names have been changed to ensure confidentiality

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Cipla and the Drugs for Neglected Diseases initiative recently announced that their malaria drug has been prequalified by the World Health Organization, an important step toward its roll-out across Asia. A new report from the Kaiser Family Foundation provides a comprehensive look at the Department of Defense's role in global health, including the department’s research and product development efforts. The US Food and Drug Administration has awarded GHTC member Aeras a grant worth $299,525 to spur the development of new vaccines against tuberculosis. A new study finds that the way medical research is funded in the United States has been vastly altered over the last 20 years by advocates asking that research be focused on particular diseases. A widespread vaccination campaign to protect 50 million people against meningitis with a new vaccine has been launched in seven African countries, health officials said Thursday.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. Christopher Austin has been named the new director of the National Center for Advancing Translational Sciences at the National Institutes of Health. A new analysis compares the innovation and science policies of presidential candidates Barack Obama (D) and Mitt Romney (R). A bill signed into law earlier this year that provided the US Food and Drug Administration (FDA) with funding is at risk due to federal budget negotiations. An opinion piece calls on US policymakers to “get serious” about funding scientific and research efforts. A breakthrough tool to combat tuberculosis has been launchedby the Critical Path Institute and the Clinical Data Interchange Standards Consortium (CDISC). The project was the result of collaboration between the Critical Path Institute, CDISC, the FDA, and others through the Critical Path to TB Drug Regimens. Researchers met this week in Boston for the AIDS Vaccine 2012 conference to discuss the latest in efforts to develop a vaccine against the disease.

  In this guest post, Joanna Breitstein, director of communications at the TB Alliance, highlights the response to a new study that indicates a novel tuberculosis (TB) combination drug may be on the horizon. Global press coverage this week cites a Lancet study suggesting that scientists have made significant progress toward developing an effective and affordable treatment for TB, a disease that every year kills more than 1.4 million people and is the primary cause of death among people with AIDS. Released on Monday during a presentation at the International AIDS Conference (IAC), the results of the Phase II trial in South Africa offer hope for a treatment breakthrough amid the growing and dangerous epidemic of drug-resistant forms of TB that, in some cases, are becoming untreatable. Image courtesy of the TB Alliance. In a story by the Associated Press, science writer Lauran Neergaard reports, “Scientists are hot on the trail of a new tuberculosis treatment that a small study suggests might one day offer an alternative to battle this deadly lung disease, even if it’s resistant to today’s two main drugs.” Asked to comment on the new study, IAC Co-Chair Dr. Diane Havlir of the University of California,San Francisco told the Associated Press, “We are cautiously optimistic that we are at the dawn of a new era for TB drugs." In The Guardian, Sarah Boseley quotes TB Alliance CEO Dr. Mel Spigelman, who calls the implications of the findings “huge.” "People with drug-susceptible and [some forms of] drug-resistant TB could be cured in as little as four months or even shorter,” Spigelman tells Boseley. “In the case of multi-drug-resistant TB, we could be reducing their treatment by one to two years or more. The regimen also promises to be in the order of 90 percent cheaper than the current [multi-drug resistant] treatment regimen. There is potential for a dramatically shorter, simpler, cheaper, and more effective regimen all at the same time.’” Also quoted in The Guardian, principal investigator Dr. Andreas Diacon of Stellenbosch University in South Africa says he speaks as a clinician and researcher. "Treating drug-sensitive and drug-resistant TB with the same regimen can simplify the delivery of TB treatment worldwide. The results of this study give healthcare providers on the front lines of the TB epidemic hopes for better, faster tools needed to stop this disease." Spigelman notes in Amy Maxmen’s article in Nature that the Lancet study also validates a new model for speeding development of such treatments. “After a new drug reaches the market, the traditional route is to work from the standard of care and substitute one drug for another. But if you do it in an incremental way, that will give you incrementally better results,” Spigelman says. “Our goal is to shorten the path to getting a new, cohesive regimen out there in one fell swoop.” Mario Raviglione, director of the Stop TB Department at the World Health Organization, says testing multiple new TB drug candidates simultaneously has already proven to be a major advance. "Because of testing drugs in combination, we have already saved several years in the research process to find new, effective regimens to treat TB," according to Raviglione. "The results look strongly promising from this early trial. If further testing holds up these results and the regimen is affordable in poor countries, it is huge progress. We could shorten drug regimens substantially for everyone, regardless of whether the form of TB is sensitive or multi-drug resistant. That would be a dramatic step forward." “If full clinical trials confirm its promise, the therapy could prove a boon for HIV-infected people,” writes Maxmen in Nature. “TB, which is common in its latent form in many parts of the developing world, often becomes active in those who are HIV-positive because of their weakened immune systems.” Unlike some existing therapies, Maxmen continues, the “new combination does not seem to interact adversely with drugs for HIV.” To illustrate the situation on the ground, where both diseases wreak havoc, Maxmen quotes John Farley, deputy director of the antimicrobial product division at the US Food and Drug Administration who once worked with HIV patients in West Africa: “…there were times when our HIV patients would die of drug-resistant TB before we could even get them their antiretroviral therapy,” says Farley in Maxmen’s story.