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. The Department of Health and Human Services releases its first-ever global health strategy, which includes a focus on catalyzing medical research worldwide. Science journal named an HIV prevention trial the breakthrough of 2011. The National Institutes of Health begins restructuring in an effort to make way for the new National Center for Advancing Translational Sciences. Scientists created a vaccine used to protect monkeys from HIV infection that could help researchers develop a vaccine for humans. A hepatitis C vaccine clinical trial shows promising results.

As people across the globe celebrate World TB Day this week, several groups are highlighting the fact that the current tools to prevent, test, and treat tuberculosis (TB) are greatly outdated. The world has been “beyond antiquated in our approach” to developing new TB tools. That is how Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, described a not-so-bygone era in the history of TB research and development (R&D). Fauci was speaking at a briefing organized by the Critical Path to TB Drug Regimensin partnership with the Global Alliance for TB Drug Development (TB Alliance), US Agency for International Development (USAID), NIAID, and the US Food and Drug Administration (FDA). During the event, representatives from key US government agencies made the case for the urgent need for new technologies in the TB toolkit. “It can’t take 40 years for us to get our next TB drug,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research stated, highlighting one of the lesser known facts about TB—that the newest drug was approved over 40 years ago. “We need to capitalize on the momentum we have,” she added. Many current TB drugs are toxic and have serious interactions with other medicines, and most regimens take over six months to complete. The disease kills 1.4 million people and infects 8.8 million each year. As people across the globe celebrate World TB Day this week, several groups are highlighting the fact that the current tools to prevent, test, and treat TB are greatly outdated. Photo credit: PATH Joining Fauci and Woodcock were Robert Clay, deputy assistant administrator for Global Health at USAID; Mel Spigelman, CEO of the TB Alliance; and Christine Lubinski, vice-president for Global Health at the Infectious Diseases Society of America (IDSA). All speakers stressed the urgent need to conduct R&D for new and improved TB prevention and treatment options. They also lauded the use of partnerships between non-profit organizations, private pharmaceutical companies, and US Government agencies in the development of new drugs and other technologies. Fortunately, the TB Alliance, a GHTC member and product development partnership (PDP), announced the launch of a new combination drug trial that could pave the way for the next generation in TB treatment approaches. The group has launched stage II trials for NC-002—a novel drug regimen combining a well-known generic TB drug with two new drug candidates. The trials will take place in South Africa, Tanzania, and Brazil, and results will be known in roughly a year. This trial is also the very first of its kind. It will test both patients with ‘drug sensitive’ TB, who do respond to current treatments, along with patients with multi-drug resistant TB (MDR-TB), who do not respond well to currently available treatment, to determine differences in the groups’ response to the new drug regimen. As Spigelman outlined, the potential impact of this trial is immense—it could reduce the costs of treating MDR-TB by 90 percent, as well as decrease treatment time by over 80 percent. This exciting news in TB drug development follows closely on the heels of new funding for new prevention tools. Last week, GHTC member Aeras announced that it received a grantfrom the Bill & Melinda Gates Foundation of up to $220 million over five years to conduct R&D for new TB vaccines. Aeras stressed that it is developing new TB vaccines against the backdrop of a significant increase in drug-resistant strains of the disease worldwide. Additionally, today Aeras—along with the TuBerculosis Vaccine Initiative and the STOP TB Partnership—also announced a new blueprint for TB vaccine development. "To develop a new TB vaccine that will be fully effective, researchers, donors, and other partners will need to collaborate and coordinate their efforts as they address tough research questions," said Dr. Lucica Ditiu, executive secretary of the Stop TB Partnership. "We cannot allow ourselves to be overwhelmed by either the costs or the obstacles. It is time to be bold and dare to do more in TB, especially in supporting the development of a new vaccine." As we recognize World TB Day, the need for new and better prevention, diagnostic, and treatment options for the disease is clearer than ever before. And it’s encouraging that GHTC members like Aeras and the TB Alliance—along with many other partners—are at the forefront of R&D efforts to create these desperately needed health tools.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. As the international community marks World TB Day, GHTC members Aeras and the Global Alliance for TB Drug Development announced research projects for new tuberculosis (TB) prevention and treatment tools. National Institutes of Health (NIH) Director Francis Collins testified at a Congressional hearing on the agency’s budget. Collins emphasized NIH’s commitment to fund basic biomedical research as the agency’s highest priority. Rajiv Shah, head of the US Agency for International Development, was also on Capitol Hill this week to discuss the agency’s budget with members of Congress. "While foreign assistance represents less than one percent of our budget, we are committed to improving our efficiency and maximizing the value of every dollar," Shah said at the hearing. Alberto Gutierrez—director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health—writes about how the FDA is helping to improve access to TB diagnostic tools.

Research!America, a member of the GHTC, recently conducted analyses in target states to measure the health and economic impact of global health research and development (R&D), highlighting its benefits for states across the nation and strengthening the evidence base for Congress’ support of federal investments in global health R&D. This is the sixth and last post in a series. "If you want to live longer and healthier than the average American, then come to New York City,” Mayor Mike Bloomberg announced in December 2011. The city’s life expectancy for a 40-year old in 2009 was 82, compared with 80.1 for the rest of the United States. Babies born in New York City in 2009 will see an increase of nearly three years on their life spans, versus 1.5 years nationwide. With the leadership of the mayor, who has an outstanding track record on public health leadership, and the dedication of its health commissioners, New York City has significantly brought down its rates of tuberculosis (TB) and stabilized the growth of new HIV infections over the last two decades. This leadership in public health also translates into a strong commitment to R&D. New York City has the world’s largest concentration of major academic research centers and the largest bioscience workforce of any city in the United States. The state is home to seven of the top 50 American research universities and attracts increased investment in the sciences with a 9 percent corporate tax break for R&D facilities. Combined with the commitment of its elected officials—and economic drivers like the new applied sciences campus, NYCTech, on Roosevelt Island—New York institutions are creating partnerships that transform how we do the business of health research. It is projected that NYCTech could in turn provide up to $150 million in seed money for up to 600 new local start-ups, which could generate an estimated 30,000 new jobs. Partnerships for health R&D contribute to the health and economy of New York, and the effects of these partnerships are felt around the world. After the National Institutes of Health, New York’s International AIDS Vaccine Initiative (IAVI) has the largest AIDS vaccine development program and partners with more than 50 other institutions to conduct research and clinical trials. The Global Alliance for TB Drug Development (TB Alliance), also headquartered in the Big Apple, manages the largest, most comprehensive portfolio of TB drug candidates ever. With the first cases of totally drug resistant TB identified in India earlier this year, identifying improved strategies to control TB has never been more critical. New York City has the world’s largest concentration of major academic research centers and the largest bioscience workforce of any city in the United States. Photo credit: PATH Public-private partnerships like IAVI and the TB Alliance rely in part on support from the federal government. Unfortunately, President Obama’s proposed fiscal year 2013 budget raises concerns for health R&D. “Public funding is evaporating at a time of tremendous opportunity. We’re on the brink of delivering potentially revolutionary new treatments for tuberculosis, with similar great promise in other areas of global health,” said Mel Spiegelman, president of TB Alliance. Former New York City Health Commissioner and current Centers for Disease Control and Prevention Director Tom Frieden agrees with the need for sustained federal investment to protect the health and safety of Americans at home and abroad. “There are still far too many people who die from conditions that are easily preventable. Continued investments will help millions more live healthy and productive lives while helping to protect our own country from health threats,” he said.