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Testing for tuberculosis in the lab. Photo: PATH/Mike Wang A new study published in PLOS Medicine indicates that multi-drug resistant tuberculosis (TB) is less contagious than drug-susceptible TB. Researchers followed 1,055 “household contacts”—relatives, neighbors, or friends living in close proximity—of 213 patients with multi-drug resistant TB and 2,362 household contacts of 487 patients with drug-susceptible TB for three years in Lima, Peru. Contacts of patients with drug-susceptible TB were nearly 50 percent more likely to become infected, with 4.8 percent developing the disease compared to 3.3 percent for contacts of multi-drug resistant TB patients. According to Dr. Louis Grandjean, the study's lead author, the TB bacteria experiences a "'fitness' cost" in which it becomes less infectious as it mutates to become resistant to antibiotics. The authors note, however, the possibility that future strains of drug-resistant TB could develop to be fitter. The Indian Ministry of Health is proposing major reforms at the Central Drugs Standard Control Organization (CDSCO)—the national regulatory authority of India. The proposal seeks to improve the CDSCO, using the US Food and Drug Administration (FDA) as its model. One of the key reforms would be a major increase in staffing, from 561 employees to 1,800 by 2025, and the Ministry of Health estimates that the overhaul would cost US$272 million. The announcement comes as the FDA ramps up inspections of foreign pharmaceutical manufacturing plants, and after several high-profile crackdowns on Indian manufacturers. The government of the Republic of Equatorial Guinea has committed $36.75 million for phase 2 and 3 clinical trials of an experimental malaria vaccine, in partnership with three oil and gas companies—Marathon Oil Corporation, Noble Energy Inc., and AMPCO—which will be contributing an additional $11.75 million. The vaccine was developed by Sanaria Inc. and initial trials suggest that it is both safe and effective. The funding will cover additional trials with 450 participants in 2016, and 3,000 participants in 2017 to 2018. The government of Equatorial Guinea and Sanaria Inc. have also signed an agreement to explore the possibility of establishing clinical laboratories and vaccine manufacturing centers in Equatorial Guinea. GHTC member Treatment Action Group and Yale University’s Global Health Justice Partnership filed a federal lawsuit against the FDA for withholding clinical trial data for two costly hepatitis C drugs that were approved by the FDA in December 2013 and October 2014. Both drugs were developed by pharmaceutical company Gilead Sciences and are intended to cure, not merely treat hepatitis C, according to the complaint, which also notes that 12-week regimens of the drugs cost $94,500 and $84,000, respectively. The two advocacy organizations requested the release of the clinical trial data from both Gilead Sciences and the FDA; Gilead denied the request, and the FDA responded that it will take 18 to 24 months to even consider releasing the data. Treatment Action Group and the Global Health Justice Partnership are arguing that the FDA’s response violates the US Freedom of Information Act, and that the data is needed so that doctors, patients, and policymakers can evaluate the “safety, efficacy, and cost-effectiveness” of the drugs.

This Independence Day, GHTC is taking a break from our cookouts and parades to celebrate America’s extraordinary contributions to advancing innovation to save lives around the world. The US government has long played a leading role in the development of new technologies to diagnose, treat, and prevent diseases and conditions impacting people living in the world’s poorest places. US leadership in global health research and development (R&D) is a testament to our nation’s character, our ingenuity and entrepreneurial spirit, and our dedication to improving human lives worldwide. Below GHTC takes a look at America’s contributions to global health innovation: The US government is the largest funder of global health R&D in the world. The US government is by far the largest funder of global health R&D—contributing around 45 percent of total investment and 70 percent of all government investment each year. Even when measured as a proportion of gross domestic product (GDP), the US government remains the largest funder of global health R&D. Between 2000-2013, the US government invested over US$18 billion in global health R&D. While this may sound like an extraordinary amount of money, annual US investment in global health R&D represents only a tiny fraction of overall US government spending—less than one-tenth of one percent of our GDP. While US investment in global health R&D nearly doubled between 2000 and 2009, funding has been largely stagnant, or on the decline, since then. A sustained and robust US investment in R&D by the United States is critical to delivering the next generation of health technologies to address both existing and emerging diseases and conditions. The US government contributes more than just funding to advance global health R&D. Five federal agencies that are engaged in global health R&D—the US Agency for International Development, National Institutes of Health, Centers for Disease Control and Prevention, Department of Defense, and the Food and Drug Administration—contribute much more than just funding. The US government has been involved in the development of many breakthrough technologies that are transforming global health. Between 2000 and 2010, the US government was involved in the development of over half (25) of the 45 global health products. The US government has been involved in the development of lifesaving innovations, including: Antiretroviral treatments, which have dramatically extended the lives of those living with HIV and AIDS. A vaccine that protects against meningitis A, costing less than $.50 per dose, which been delivered to more than 251 million people in Africa’s meningitis belt since its launch in 2010. A pediatric antimalarial drug, which has had 300 million treatments delivered to children suffering from malaria in 50 endemic countries since 2009. US investment is fueling a robust pipeline of global health products with the promise to save and improve lives. As of 2012, the US government was involved in the development of 200 of the 365 global health products in the development pipeline. Promising innovations under development receiving support from the US government include: A preventative HIV and AIDS vaccine that could dramatically reduce new infections. New tools to prevent and treat malaria, including medicines that will both protect against the disease and prevent its transmission. Vaccines to prevent tuberculosis (TB), which are in various phases of clinical trials. New cost-effective diagnostics for malaria, TB, and neglected tropical diseases (NTDs). New vaccines for NTDs—such as dengue fever, Chagas disease, and leishmaniasis. US contributions to global health R&D are having a ripple effect beyond saving and improving lives. US contributions to global health innovation not only saves lives, but also produce direct benefits for Americans by creating jobs, strengthening US competitiveness in research and technology, improving US relations abroad, and enhancing our health and national security. US investments also drive economic progress and reduce poverty in low- and middle-income countries (LMICs). Between 2000 and 2011, health improvements accounted for about 11 percent of economic growth in LMICs. The development of new health technologies will ultimately provide LMICs with the solutions they need to tackle their most pressing health challenges and chart a course for self-sustainment. So this Fourth of July, as you enjoy your burger and watch fireworks light up the sky, take a moment to celebrate America’s contributions to global health. While there is much more to be done, Americans should take pride in our nation’s efforts to advance innovation to save lives worldwide.

In this guest post, Kerry Aradhya—a science writer from GHTC member FHI 360—discusses a new website launched by FHI 360 to increase global access to resources that will help advance contraceptive research and development (R&D). Over the past several decades, overall investment in contraceptive R&D has declined dramatically. The result? Renewed commitment and partnerships will be required to ensure that new contraceptive methods advance through the development pipeline and that access to the final products is affordable and equitable. This is especially true in low-resource settings where unmet need for family planning remains high. With funding from the Bill & Melinda Gates Foundation, FHI 360 has developed a new website to increase global access to resources that will help move these ideas into practice. Launched in June 2015, the Contraceptive Technology Innovation (CTI) Exchange includes a resource library focused on contraceptive research, development, registration, and introduction and a blog that offers timely news, events, and commentary on topics that are moving contraceptive innovation forward. Here are four reasons you should visit the CTI Exchange today: 1. Diverse partnerships are critical for advancing contraceptive innovation. A wide range of groups—including donors, academia, nongovernmental organizations, and private industry—will need to work together to find innovative solutions to reduce unmet need for family planning and to bring products to market that better serve women and men around the world. As a platform for collaboration and knowledge sharing, the CTI Exchange facilitates the development of these partnerships. 2. New and existing resources are at your fingertips. Looking for information related to contraceptive R&D, regulatory requirements, quality assurance, or advocacy? The CTI Exchange’s resource library provides easy access to more than 130 resources and is frequently updated to incorporate new releases. Several of GHTC’s resources are included, and the Global Health Regulatory Requirements Database is currently a “featured resource” on the site. 3. A new database highlights contraceptive products in the development pipeline. A new key resource on the CTI Exchange—Calliope, the Contraceptive Pipeline Database—includes information about more than 170 contraceptive products that are in development or are being marketed on a limited basis. The database can be used to explore past and ongoing product development efforts, identify opportunities for future investments, and learn about products that may be available in the near future. 4. Your knowledge and experiences can be shared widely. Through its resource library and blog, the CTI Exchange facilitates the sharing of information among a global consortium of partners. Because your knowledge and experience is needed to grow the site, the CTI Exchange invites you to participate. Contribute resources. Write blog posts. Ask questions. Visit the exchange today!

A woman's hands holding a SILCS diaphragm. (Photo: PATH/Patrick McKern) Last week, GHTC member PATH launched the Caya® contoured diaphragm in the United States, after developing and testing nearly 200 prototypes to ensure the product was safe, effective, and user friendly. PATH collected input from women and health care providers across the globe throughout the research and development (R&D) process, ultimately creating an innovative contraceptive that protects against sexually transmitted infections, has no side effects, and is discreet, comfortable, easy to use, and “one-size fits-most." The Caya® diaphragm, which is now available in 25 countries, is an important addition to existing contraceptive options, as it is the first diaphragm introduced in the United States in 50 years. In 2014, the World Health Organization (WHO) recognized the Chinese Food and Drug Administration as a functioning regulator; China has now developed two vaccines—for Japanese encephalitis and influenza—that have received WHO prequalification, a sign that a product is safe and effective. A representative of the Bill & Melinda Gates Foundation, which has worked with the Chinese government to enhance its vaccine R&D capacity, said that the second prequalification “may be the start of China truly becoming a player in global health.” China recently established a system that regulates manufacturing for pharmaceutical products based on the European Medicines Agency’s (EMA) and US Food and Drug Administration’s (FDA) standards. However, China’s regulatory system still has some barriers to overcome, as the regulatory approval process takes much longer than the EMA’s or FDA’s. Additionally, the Chinese government requires vaccines and drugs to be packaged individually—which is not conducive to international shipping—and there are currently no guidelines on how a manufacturer can obtain a license in China if clinical trials are conducted abroad. A vaccine candidate for the Middle East Respiratory Syndrome (MERS) has been successfully tested in mice and will progress to Phase I clinical trials shortly. The vaccine uses a weakened strand of a poxvirus—known as Modified Vaccinia virus Ankara—that has been altered to display a certain protein unique to the MERS virus. The immune system recognizes the protein as foreign, and develops antibodies and T cells to combat MERS. In the lab, the MERS virus was not able to reproduce in vaccinated mice despite exposure to “high levels” of the virus. The vaccine was developed by the Ludwig Maximilian University of Munich’s Institute for Infectious Diseases and Zoonoses, and the German Center for Infection Research has already committed 1.5 million euros for the Phase I clinical trials. The results of a massive trial for a new pneumonia vaccine were announced last week, demonstrating a major reduction in cases of the disease responsible for fifteen percent of deaths in children under five years of age. The vaccine, known as PCV-10, protects against ten different bacteria that can cause pneumonia. The trial lasted seven years, during which time the vaccine was given to 35,000 children in the Kenyan town of Kilifi. Eighty percent of vaccinated children demonstrated greater resistance to pneumonia. The town saw a 42.7 percent reduction in cases overall, and a 95 to 100 percent reduction in invasive pneumococcal disease—the most deadly form of pneumonia.