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In this guest post, Dara Erck, vice president of external affairs at Aeras, discusses the new White House National Action Plan for Combating Multidrug-Resistant Tuberculosis and how it could accelerate research and development (R&D) of new technologies to combat multidrug-resistant TB (MDR-TB). When the World Health Organization (WHO) unveiled its Global Tuberculosis Report 2015 last October, the most striking revelation was that tuberculosis (TB) is now the world’s leading single infectious disease killer, accounting for 9.6 million illnesses and 1.5 million deaths in 2014. And the report’s findings about MDR-TB were also alarming, noting 480,000 cases of MDR-TB globally in 2014, with nearly 10 percent of these being extensively drug resistant (XDR-TB). Considering this high human toll in context of the estimated annual US$1.3 billion funding gap for TB R&D, it is clear we must achieve a sea change in the global approach to TB R&D funding. This is why there was much hopeful anticipation for the release of the White House’s recent plan to address MDR-TB, as a follow up to its 2014 National Action Plan for Combating Antibiotic Resistant Bacteria. Released in late December 2015, the National Action Plan for Combating Multidrug-Resistant Tuberculosis is a product of countless hours of collaboration between the Obama Administration and its partners in government, including the White House Office of Science and Technology Policy which convened an interagency working group including the US Agency for International Development, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the State Department, and others. During the course of the plan’s development, TB advocates vigorously urged the Administration to broaden the goals related to MDR-TB. And the White House listened. The goals of the action plan are to strengthen domestic capacity, improve international capacity and collaboration, and accelerate basic and applied research to combat MDR-TB. I am especially pleased to see this acknowledgment of the critical role of TB R&D. Accelerating basic and applied research to combat MDR-TB is absolutely necessary if we are to conquer the TB epidemic. The plan recognizes that “ultimately, an effective vaccine to prevent all forms of TB will be required to eliminate TB globally.” This acknowledgment is an important step, indeed. But we must not ignore that funding this critical work is a necessary next step. We simply cannot discover and develop the new tools required to end this deadly epidemic without urgently needed additional resources. I urge President Obama to include robust funding for implementing agencies in his fiscal year 2017 budget. TB vaccine research. Photo: Aeras The plan outlines a significant focus on R&D. In the coming year, NIH is directed to expand its TB dialogue among basic scientists, funders, and vaccine developers to identify novel strategies for vaccine development, encourage research related to vaccine design, and educate partners about resources available to contribute to vaccine development, as well as continue to support studies to map the diversity of immune responses required for vaccine efficacy. Within three to five years, NIH is tasked with continuing its support for TB research, preclinical studies, and clinical trials and studies for the evaluation of new vaccines, adjuvants, and preventive drugs. NIH and CDC will also intensify collaborations with domestic and international vaccine developers to leverage preclinical and clinical resources for vaccine development. These directives are an important move in the right direction—but without significant new strategies and resources, the scientific community will struggle to advance new vaccine candidates that can prove effective in providing protection against TB. I am particularly encouraged to see the call for collaboration with private-sector organizations including nonprofit product developers. At Aeras, we partner with a wide range of academic and pharmaceutical organizations dedicated to TB vaccine research. And we aren’t alone—other nonprofit product developers such as TB Alliance and FIND lead their fields in new drug and diagnostic development, respectively. The release of this plan was an exciting moment for all TB advocates and researchers, as it attracts new and much needed attention to the threat of MDR-TB. It provides the opportunity to create renewed accountability for ending this deadly epidemic. It also validates and supports other initiatives, including the WHO’s aim to end the TB epidemic by 2035, and the United Nations’ new Sustainable Development Goals which target ending the TB epidemic by 2030. But for the plan to be successful, Congress will need to dedicate the resources necessary to achieve its ambitious treatment, diagnostic, and vaccine development targets. The US government is a key partner in this critical work. I deeply appreciate the Administration’s efforts to create this plan and hope that the US Congress will provide the funding that is so urgently needed to realize a TB-free world.    

President Obama 2016 State of the Union address. Photo: White HouseGHTC has long championed US leadership in global health and innovation, and we were encouraged to see President Barack Obama highlight these themes in his State of the Union address.On combating the 2014 Ebola epidemic in West Africa, the president highlighted a coordinated domestic and international effort to leverage expertise, resources, and value-add of all partners—a strategy we support for advancing global health R&D. He stated: Fortunately, there’s a smarter approach, a patient and disciplined strategy that uses every element of our national power. It says America will always act, alone if necessary, to protect our people and our allies; but on issues of global concern, we will mobilize the world to work with us, and make sure other countries pull their own weight… That’s how we stopped the spread of Ebola in West Africa. Our military, our doctors, and our development workers set up the platform that allowed other countries to join us in stamping out that epidemic. The president also discussed US investments in global health and development as a core piece of American foreign policy and national security, nodding to the Global Health Security Agenda, which coordinates domestic and international efforts to prevent, detect, and respond to global disease epidemics. In addition, his message called for renewed commitment and funding for US efforts to end the epidemics of HIV and AIDS and malaria: Leadership means a wise application of military power, and rallying the world behind causes that are right. It means seeing our foreign assistance as part of our national security, not charity. When we help African countries feed their people and care for the sick, that prevents the next pandemic from reaching our shores. Right now, we are on track to end the scourge of HIV and AIDS, and we have the capacity to accomplish the same thing with malaria — something I’ll be pushing this Congress to fund this year. President Obama also highlighted the transformative power of medical research to end endemic and emerging health threats: For the loved ones we’ve all lost, for the family we can still save, let’s make America the country that cures cancer once and for all. Medical research is critical. GHTC is pleased to see President Obama echo themes we have long advocated: partnerships and innovation are key to advancing health at home, and around the world.To curb the spread of emerging disease epidemics, we will need domestic and international commitment to work together and develop new tools and technologies to monitor, track, diagnose, and treat infectious disease. To finally end the scourge of malaria and achieve an AIDS-free generation, we will need renewed commitment to develop innovative vaccines and treatments that move us beyond current interventions. To cure noncommunicable diseases and other health challenges that plague developed and lower-income countries, we need continued investment in research and development for health technologies.GHTC looks forward to working with the president and his administration to drive these issues forward in 2016.

A recent clinical trial found that convalescent plasma therapy, a treatment in which the blood plasma is taken from survivors of a disease and used to treat current patients, did not prove to be effective against Ebola. The blood plasma of survivors includes antibodies against the pathogen, in this case the Ebola virus, which can boost a patient’s immune response. Convalescent plasma therapy has been used for more than 100 years, and was first used against Ebola in 1976. In the trial, plasma therapy was used to treat 84 patients, and an additional 418 patients that had been treated at the same facility served as the control group. The treatment reduced death rates by a mere 2.6 percent, and the result was not statistically significant. However, the trial did demonstrate that the collection and transfusion of blood plasma from survivors to patients was safe and feasible in low-resource settings. During the trial, the therapy did appear to be particularly effective in pregnant women and infants, however, the sample size was too small to confirm. Plasma samples from the trial will now be sent to a facility in France where researchers will assess the concentration of antibodies in the samples to determine if the quantity of antibodies affected survival rates. A recent study suggests that the antimalarial artesunate/amodiaquine (ASAQ) could be more effective against Ebola than artemether/lumefantrine (AL), an antimalarial previously used to treat Ebola, due to the diseases’ overlapping symptoms. During the outbreak, a Médecins Sans Frontières treatment center in Liberia initially used AL to treat patients, however, after running out of AL, they began to use ASAQ. The death rate for patients receiving ASAQ was 50.7 percent, compared to 64.4 percent of patients on AL. While ASAQ appears to be a promising treatment, additional trials are needed to investigate ASAQ’s efficacy in reducing Ebola mortality. Strains of the bacteria responsible for the sexually transmitted infection gonorrhea are becoming increasingly resistant to antibiotics. In the United States, one-third of gonorrhea cases are resistant to at least one antibiotic. Public officials, both in the United States and Britain, are urging doctors to follow prescription recommendations to prevent the spread of drug-resistant strains. In Britain, many doctors continue to prescribe ciprofloxacin, which has not been recommended for gonorrhea in 10 years. In the United States, doctors have historically prescribed ceftriaxone, however, between 2011 and 2013—after new guidelines led doctors to prescribe ceftriaxone in combination with azithromycin—ceftriaxone-resistant strains decreased by two-thirds from 1.4 percent to .4 percent of cases. Cow standing in a grassy field. (Photo: PATH/Eric Becker) The bacteria Mycobacterium bovis, which causes bovine tuberculosis (TB), is a rising cause of human TB, and while it’s responsible for just 1.4 percent of cases globally (and 1.5 percent of cases in America), up to 44 percent of TB-infected Latino Americans have the bovine version. Bovine TB is found in two dozen mammal species and is usually transmitted to humans through unpasteurized dairy products. In Mexico, 40 percent of dairy products are unpasteurized, and consequently the proportion of bovine TB cases among Americans are highest along the US-Mexico border. Two-thirds of bovine cases in the United States are extra-pulmonary—outside of the lungs—and are consequently undetectable by standard diagnostic techniques. The remaining third, confined to the lungs, could presumably be spread between humans through coughing or sneezing.