Kat Kelley

On Thursday, March 26, 2015, the Global Health Technologies Coalition (GHTC) launched its sixth annual policy report titled Meeting the challenge, seizing the opportunity: US leadership can advance global health R&D with a luncheon and panel discussion on Capitol Hill. The recent Ebola crisis was a common theme as panelists discussed what lessons could be learned about the need for further global health research and development (R&D) to enhance America’s preparedness to address future health threats. Dr. Joanne Carter—executive director of GHTC member RESULTS and moderator of the event—opened the discussion by reflecting on recent successes in global health R&D, while also emphasizing the need for increased investments in tools to tackle existing and emerging public health challenges. Carter noted how years of budget stagnation and sequester cuts have stymied the development of promising technologies and eroded US preparedness to tackle global health threats like Ebola. She expressed that “as we have achieved hard fought gains, challenging fiscal circumstances have put funding for global health product development at risk. Global health crises like Ebola and emerging obstacles like antibiotic drug resistance have demonstrated that existing tools are not enough. If we are going to successfully combat these challenges and reach our goal of a healthier world, we must continue to innovate.” Panelist Daniel Bausch, MD, MP&TM—senior consultant for the Clinical Team in the Department of Pandemic and Epidemic Diseases at the World Health Organization—echoed the need for forward-looking investments in R&D and preparedness, noting that the world has spent much more money fighting Ebola than it would cost to prevent the epidemic. Bausch maintained that while the US and global response to the Ebola crisis was unprecedented, we must learn from our failures to combat future epidemics. He underscored that R&D should be treated as a preventative measure, rather than a response to a crisis, reminding the audience that the clinical trial process can take years, even decades. Bausch called for increased long-term US government investments in global health R&D and strengthening health systems and R&D infrastructure in developing nations, noting that in an increasingly interconnected world “US health is global health.” Panelist Ann Mei Chang—executive director of the US Global Development Lab at the US Agency for International Development (USAID)—echoed Bausch’s remarks admitting that the US government is “much better at responding to crises than investing long term.” Bausch further cited the challenges that budget cuts pose for global health researchers, explaining that “if you’re a researcher in a university setting, you probably spend at least 50 percent of your time looking for funding.” He further remarked that research is often stalled because researchers lack the funding to continue their work in an already long and difficult process. Panelist Captain Michael Schmoyer—director of the Office of Pandemics and Emerging Threats at the US Department of Health and Human Services (HHS)—remarked that there were bright spots in the US response to Ebola, including the ability of US agencies to collaborate and work together. He asserted that during the outbreak, coordination between HHS, the Centers for Disease Control and Prevention (CDC), USAID, the Department of Defense (DoD), and the Food and Drug Administration was unprecedented. Captain Schmoyer confessed that agency leaders surprised themselves with their ability to work effectively together and that the response to the Ebola crisis could serve as a model for US agency coordination moving forward. He cited the example of how HHS worked with other agencies including the DOD, CDC, and USAID to set up the first medical unit to care for those healthcare workings responding to Ebola. The other panelists agreed that partnership and collaboration, both across the US government and with other sectors, is essential to advancing global health R&D during times of crises and under normal circumstances. Chang discussed how the US Global Development Lab at USAID advances R&D by leveraging existing funding through diverse partnership from different sectors including the private sectors, nongovernmental organizations, universities, and local government. She emphasized the value of open innovation, through calls for proposals and ideas, to elevate previously untapped voices. Chang cited an example of the value of this collaborative model during the Ebola outbreak. USAID partnered with the White House Office of Science and Technology, CDC, and DoD to launch the Fighting Ebola Grand Challenge for Development, focused on improving the personal protective equipment used by healthcare workers on the front line. Chang said the competition received ideas from engineers, architects, and even wedding dress designers, and now USAID is working with a manufacturer to develop the winning design and introduce it into the field. Captain Schmoyer further endorsed the value of partnership noting that some of the simplest, but most invaluable, ideas generated in the Ebola response resulted from consulting new partners. All three panelists agreed that there were lessons the US could learn from the Ebola crisis to enhance our nation’s preparedness to respond to future health threats. Carter closed the event by noting that “As the world creates a new agenda for global development and seeks to confront existing and emerging health challenges, the time is right for US policymakers to strengthen the nation’s investments in research and product development and reaffirm our resolve to harness American ingenuity to save lives, improve health, and enhance economic prosperity and security around the world.” She called on US policymakers to “meet the challenge and seize the opportunity.” For more information, find the full report here and an accompanying piece on the site Medium.

The National Institute of Allergy and Infectious Diseases (NIAID) announced last week that two experimental Ebola vaccines appear to be safe for widespread use, based on early results of clinical trials in Liberia. NIAID will now expand its trials to include as many as 1,500 volunteers, testing the vaccine candidates for efficacy. Volunteers will receive either the vaccine candidate developed by GlaxoSmithKline, another developed by NewLink Genetics Corp, or a placebo. Researchers will examine the immune response to the vaccines to see if participants develop antibodies against Ebola. None of the participants will be intentionally exposed to the Ebola virus. Scientists at NIAID have identified several genetic conditions that affect one’s risk for malaria, and which primarily manifest as red blood cell abnormalities. The researchers followed 1,543 children in Mali for three years, during which time they recorded 4,091 cases of malaria. Genetic disorders that either decreased the production of hemoglobin—the protein that transports oxygen in the blood—or led to the creation of hemoglobin C, an abnormal form of the protein, were associated with increased risk for malaria. Two genetic traits—HbAS and homozygous X-linked G6PD deficiency—appear to protect against malaria. The HbAS gene was not only associated with lower risk for malaria, but with less severe cases of malaria in children who contracted it. Researchers at Cornell University have mapped the genome of Ancylostoma ceylanicum, one of two species of hookworm that infect humans. The study identified 31,000 different genes, including those that are active in hookworms during infection. Scientists believe that as many as 70 of those genes could be promising targets for new drugs or vaccines, and plan to start testing experimental vaccines in hamsters this year.

A team of scientists at Heinrich-Heine Universität Düsseldorf have identified a potential new player in the fight against tuberculosis (TB). Researchers have isolated several compounds with the ability to combat Mycobacterium tuberculosis, the bacteria that causes TB, from a collection of marine sponges indigenous to Indonesia. Initial experiments suggest that resistance to the compounds is possible, but develops slowly. Moving forward, the team will examine how the compounds target and combat TB and how resistance can be averted. A study published in Immunity journal last week answers critical questions in the search for a malaria vaccine. Antibodies alone have proven ineffective in fighting malaria; new research, however, indicates that malaria antibodies enlist proteins in the blood to aid in the immune response. These proteins, known as complements, help coat the malaria organism, which blocks it from infecting red blood cells. Researchers at the Burnet Institute in Melbourne, Australia, hope to work with pharmaceutical companies to develop a vaccine that triggers the necessary response from complement proteins. In an op-ed for the New York Times, Bill Gates, co-chair of the Bill & Melinda Gates Foundation, contended that the world is not prepared to fight a global pandemic. Gates cited the recent Ebola epidemic in West Africa, calling for increased investments in health systems strengthening, disease surveillance, and research and development (R&D) for drugs, vaccines, and diagnostics. Gates also emphasized the need for regulatory policies that expedite R&D in emergency situations.

Scientists at Karolinska Institutet in Sweden have identified the protein that explains why people with blood type O are protected from coma and death resulting from severe cases of malaria. Plasmodium falciparum, the parasite responsible for nearly all fatal cases of malaria, releases the RIFIN protein, which causes red blood cells to stick to one another and restrict blood flow, resulting in tissue damage and death. The study, published last week, establishes that the RIFIN protein insufficiently attaches to type O blood cells, despite its strong adherence to type A blood cells. This results in different health outcomes for those with type O blood, as they avoid the severe effects of the parasite. An article in Al Jazeera explored the history of Ebola vaccine research and development (R&D) and the barriers to conducting clinical trials in Sierra Leone today. While Ebola vaccine research began more than ten years ago, multiple promising vaccine candidates have remained in limbo due to a paucity of funding. Last fall, the US government partnered with pharmaceutical companies to expedite the R&D of experimental Ebola vaccines in light of the epidemic in West Africa. The US Centers for Disease Control and Prevention (CDC) and pharmaceutical company Merck & Co. are preparing for clinical trials in Sierra Leone involving 6,000-8,000 health workers. Health workers have expressed concern regarding the safety of the vaccine, and outreach to health workers and potential participants—which the CDC plans to conduct a few weeks prior to the start of the trial—may present a greater challenge than originally anticipated. A new diagnostic device, called the Microlife Vital Signs Alert, could save up to 70,000 mothers each year by alerting health care workers when a woman is at risk of going into shock due to blood loss during childbirth, or if her blood pressure is dangerously high. The device, which only costs US $20, is easy to use and interpret, enabling health care workers—regardless of education and training—to identify when a woman needs to be taken to a hospital with a simple red light.

The US Agency for International Development (USAID) announced last week that Ariel Pabos-Mendez, the assistant administrator for Global Health, will serve as the coordinator for Child and Maternal Survival. USAID stated that his "dual role" will ensure that maternal and child health remains a “central priority” of the Bureau of Global Health. Katie Taylor, who served as the interim coordinator, was named deputy coordinator, and will continue to serve as deputy assistant administrator for Global Health. Researchers at Johns Hopkins University made a groundbreaking discovery about the pathogen that causes tuberculosis, which could ultimately lead to the development of more effective drugs and vaccines. The bacteria generates pieces of DNA that—to the immune cells—resemble and behave like a virus, and thus the immune system responds to the bacteria as though it were a virus. That virus-like piece of DNA, known as c-di-AMP, elicits the production of INF-beta proteins as part of the immune response. The scientists infected mice with tuberculosis bacterium that was manipulated to release elevated numbers of c-di-AMP molecules, and the mice survived twice as long as those infected with normal tuberculosis bacterium. Last week, the US Food and Drug Administration approved LILETTA™, a hormonal intrauterine device developed by Medicines360, a nonprofit biotech company focused on women’s health. Medicines360 is partnering with Actavis to market and lead sales for the device. While the article notes the paucity of nonprofit pharmaceutical companies, it highlights OneWorld Health, which recently merged with PATH and whose founder also founded Medicines360. The organization, which relied on donors throughout the research and development (R&D) of LILETTA™, intends to sustain itself on sales moving forward. The Council on Foreign Relations took an in-depth look at the history of artemisinin, the leading agent used to treat malaria, from discovery through R&D for effective drugs. The search began when the Plasmodium falciparum parasite, which is responsible for the vast majority of malaria cases, developed resistance to existing treatments. In 1967, the Chinese government established a team of nearly 500 scientists, who identified and researched an extensive list of herbs and traditional medicines, ultimately confirming the efficacy of artemisinin in treating malaria. The article is part of a series, the next of which will focus on the market landscape and dynamics for artemisinin-based products.

A new compound has successfully protected monkeys from HIV, according to a study published in Nature last week. The compound stimulates the production of claw-shaped proteins that are able to simultaneously block the two different parts of white blood cells—the CD4 and CCR5 binding sites—to which the HIV virus normally attaches. After scientists at the Scripps Research Institute “vaccinated” monkeys with the compound, they repeatedly tried and failed to infect the monkeys with large doses of varied HIV strains over the course of a year. The team will next test if they are able to slow the replication of virus and the progress of the diseases in monkeys infected with HIV, before starting human trials. Last week, the World Health Organization approved the ReEBOV Antigen Rapid Test for Ebola, which requires only a test tube and a piece of paper and can provide results in approximately 15 minutes. The test is simple to administer and interpret, with the lead developer explaining “a drop of blood is placed on the paper, and if two lines appear, then it’s positive for Ebola.” The use of blood, however, requires a ‘biosafety cabinet’ in the form of either a box or a tent that can protect health workers from the virus. The test also has specificity and sensitivity issues, only detecting 92% of cases and with approximately 15% of uninfected people testing positive for Ebola. CBS correspondent Bob Simon investigated ZMapp, an experimental drug for Ebola, as part of his final story for 60 minutes before his death last month. Prior to the current Ebola epidemic, ZMapp had only been tested on monkeys; however, last summer, it was used to treat seven patients, five of whom survived. The US National Institute of Allergy and Infectious Diseases commenced clinical trials for ZMapp in Liberia on Friday. ZMapp is created using tobacco plants, which are saturated with a gene that stimulates the production of Ebola-fighting antibodies. As the plant grows, increasing rates of antibodies are produced—a process Simon likened to “a Xerox machine for antibodies.” Secretary of State John Kerry testified before the House Foreign Affairs Committee last Wednesday on the US Department of State’s 2016 budget proposal. The Committee’s Ranking Member Eliot Engel (D-NY) emphasized the importance of global health “research, infrastructure, and personnel,” in preventing future epidemics such as the Ebola crisis in West Africa and expressed his dismay at “proposed cuts to global health programs dealing with tuberculosis [and] neglected tropical diseases.”