Breakthroughs Blog: Tuberculosis

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.  

The world of HIV and AIDS research and development (R&D) is changing dramatically, and sessions this week at the XIX International AIDS Conference have examine how R&D advocates need to adapt and adjust their strategies in this new environment. The global financial crisis is at the forefront of many people’s minds, along with issues like increasing demands on already strapped country-level budgets and the possible shift from the Millennium Development Goals to the Sustainable Development Goals. At a session on Tuesday to discuss persuading policymakers to invest in tuberculosis (TB) R&D, Richard Horton from the Lancet said that TB advocates have recently recognized the need for a different approach that involves going directly to policymakers, as well as bringing TB scientists and researchers together with national decision-makers in order to create a collective will to address the leading killer of HIV-positive people worldwide. Two members of parliament from the United Kingdom—Cathy Jamieson and Pamela Nash—stressed that in addition to making their evidence and arguments simple and understandable, advocates need to connect their issues to a politician’s constituents, as constituents are always a policymaker’s top priority. “My job as a politician is to listen to the evidence and expertise that you bring, and then make sure funding is available to address those priorities,” Jamieson said. (from left to right): GHTC Director Kaitlin Christenson, IAVI's Prince Bahati, Henriette Laursen of AIDS-Fondet, Christine Lubinski from the Infectious Diseases Society of America, and Chamunorwa Jefrey Mashoko from AVAC. Photo credit: PATH Later that afternoon, the GHTC and several coalition members—Aeras, AVAC, the International AIDS Vaccine Initiative (IAVI), and the International Partnership for Microbicides—hosted a session to discuss how advocates can adapt their advocacy to meet today’s challenges. Four main themes emerged—the first focused on taking a community approach to R&D advocacy that includes a range of diseases and products. “Policymakers are tired of vertical advocacy,” Prince Bahati of IAVI said, adding, “We as advocates have the opportunity to create a platform of integrated advocacy, comprised of advocates, and scientists. We need to adapt to the transition that is happening and create one voice.” Chamunorwa Jefrey Mashoko, an AVAC advocacy fellow, added that a key part of this effort will involve scientific collaboration between African and American researchers. Panelists also discussed the need to engage new voices in their advocacy, including researchers working on new HIV and TB tools, as well as the people and communities who will ultimately benefit from these new products. Christine Lubinski from the Infectious Diseases Society of America said that some of the most successful project she’s worked on involved taking members of Congress to African countries in order to see first-hand TB and HIV research projects and clinical trials, and to meet African scientists. She added that it’s vital to show policymakers that there is a domestic constituency who believes in global health R&D, comprised of academic institutions, scientists, and researchers. “We have game-changing tools in the pipeline,” Lubinski said, adding, “We have a real opportunity with some of these new products, and I believe that’s our biggest weapon as advocates.” Additionally, the panelists talked about how there is a great need to recognize investments that have been made in global health R&D from donors, as well as how to engage new donors from countries such as Brazil, Russia, India, and China. Finally, the panelists stressed the importance of advocating for new tools as well as increased access to existing and proven tools. “There really isn’t a division between advocating for R&D and advocating for existing tools,” Henriette Laursen of AIDS-Fondet said. She added, “We can look at the historical successes of R&D and recognize that they are both part of the package.” Kim Lufkin is the GHTC’s communications officer.