Kim Lufkin

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The recently released annual G-FINDER survey found that total global funding for neglected disease research in 2012 amounted to $3.2 billion, which included an increase of $92.1 million—or 3.2 percent—over 2011 levels. Unfortunately, non-US government funding fell by 12.4 percent in 2012, with 11 governments either cutting or freezing funding. This drop was offset by an increase in US government funding by 6.4 percent from 2011. After returning from the 8th International Summit of Heads of Medicines Regulatory Agencies in Amsterdam, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg wrote in FDA Voice about the increasing need for international regulatory agencies to work together. The FDA has granted GHTC member Medicines for Malaria Venture and pharmaceutical company GlaxoSmithKline Breakthrough Therapy designation for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria. The Bill & Melinda Gates Foundation has named Susan Desmond-Hellmann, chancellor of the University of California, San Francisco, as its new CEO. A new article on SciDev.net examines how science is now more influential within the US Agency for International Development than it has been for the last two decades. Civil society groups are reacting to a set of demonstration projects recently selected by a World Health Organization expert panel to find new ways to fund health research for neglected diseases.

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. The GHTC has launched a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our second post is by Natalie Nelson, a tuberculosis (TB) survivor from Tennessee who believes that if USAID expanded its support for health R&D to include TB vaccine research, the agency could help change the lives of TB patients like her worldwide. Q: Many people think of TB as a disease of the past—or a disease that only impacts people in developing countries. But your experience with TB demonstrates that the disease impacts Americans, too. How did you contract TB, and how has the disease impacted your life in the US? A: I was working as a volunteer physical therapist in a small healthcare facility in South Africa when I contracted TB. I assisted patients infected with TB and HIV. After I came home to the US, I started getting sick. It took an entire year to be correctly diagnosed—and after finding out I had multi-drug resistant TB (MDR-TB), my life drastically changed. TB forced me to quit my job as a physical therapist. I received a 2-year treatment program, a mask, an isolation sentence, and with that, a new stigma. My life and my desire to return to South Africa were both placed on hold as I accepted a new lifestyle: swallowing drugs as I was directly observed by a health care provider each morning and afternoon and a drug infusion for 2 hours, 5 days a week for the first 6 months, then 3 days a week for the next year and a half. Natalie Nelson is a TB survivor from Tennessee who believes that if USAID expanded its support for health R&D to include TB vaccine research, the agency could help change the lives of TB patients like her worldwide. Credit: Aeras. Although the treatment was completely exhausting both physically and mentally, having TB brought an awareness that I never would have experienced otherwise. I feel blessed to have the care that I received, and now I can fight for and speak up for those who do not have the same options. Q: Your story also demonstrates the growing issue of resistance to currently available TB treatment options, which makes the disease much more difficult and expensive to treat. What was that experience like for you, in terms of undergoing TB treatment, its side effects, and its costs? A: Having TB was extremely scary. So many things were uncertain, and the questions were endless. Was the medicine working? Would I eventually need surgery? Would I even survive? No one could tell me definite answers. I just had to keep pressing forward and swallowing the pills, as there was no alternative. There were numerous side effects from the medication—it seemed like a new one would surface each week. First, I was terribly weak and frail. I lost over 20 pounds and my iron levels bottomed out, so I was tired all the time. Then, I developed excruciating kidney stones in both kidneys. Every afternoon around 3:00 my face would flush, my temperature spiked, and I had to lie down. At times, my fingers went numb, and I dropped things constantly. Though all of this was terrible, the worst side effect was short term memory loss from Cycloserine—the drug I was taking to treat my TB. I forgot what I was saying mid-sentence, and constantly repeated myself. I got lost driving and forgot to show up to appointments. I became socially awkward and utterly undependable during this time. This was really difficult and embarrassing. The costs were astronomical. TB cost me my job, my energy, years of my life, special moments with friends and family, my health—and at times—my sanity. I am unsure of the exact dollar amount because there are some losses that can't be calculated, but the cost was easily over half a million dollars. Q: Currently, there is only one vaccine to prevent TB—the Bacille Calmette-Guérin (BCG) vaccine. While BCG is the most widely used vaccine in the world, it has not successfully eliminated the disease due to its limited efficacy. Based on your personal experience with TB, how would new and improved vaccines—as well as treatment options—help in the fight against TB worldwide? A: We can never truly eradicate TB without a vaccine, better diagnostics, and treatment options. I passionately believe that prevention is key and that new vaccines and treatments could mean billions of dollars saved every year. It would mean that TB would not be a plane ride away. It would mean the college student on spring break traveling to Africa for mission work wouldn't have to worry about his safety. Currently, it would mean that the person who dies every 30 seconds of every day of TB would not. Q: As you know, USAID currently does not support research to develop new TB vaccines. How would support from USAID for TB vaccine research help patients like you in the US and around the world? A: Support from USAID to develop new vaccines will mean moments and years and lives saved around the world. A vaccination before my trip to South Africa might have changed everything. The truth is I will never know what could have been. But what IF I had received an improved TB vaccine before traveling? Maybe I would have returned home and never lost my job as a physical therapist. Maybe I would have stood next to my friend Laural as she said her vows, rather than lying in bed on isolation. Maybe I would have been more present in my friends’ and family's lives during those three years. Maybe I would have gone back to South Africa. For countless others around the world, a better TB vaccine would be life-changing. Maybe a mother will not worry about passing the disease to her children. Maybe a doctor will save millions of lives. TB does not discriminate. It does not matter who you are—if you breathe, you are at risk. This is why support for research of new vaccines is absolutely imperative. USAID should absolutely choose to be a part of this global fight. After all, who would willingly choose to NOT be a part of claiming lives were SAVED, lives were LIVED, and dreams were PURSUED? I hope we can all confidently say we were a part of this solution.

The US Agency for International Development (USAID) is the nation’s lead foreign assistance agency. Throughout its 50-year history, USAID has worked with other government agencies, the private sector, and nongovernmental organizations to support the development and introduction of affordable health products appropriate for addressing the diseases and health issues in developing countries. Today, the GHTC is launching a new blog series to highlight the impact of USAID’s commitment to global health research and development (R&D). The series will showcase stories from individuals who have benefited from the agency’s support and investment in R&D—as well as people whose lives would vastly improve if USAID were to expand its support for health R&D into new areas. Our first post is by Ted Prusik, senior vice president of Temptime. Temptime is a New Jersey-based company that has made a huge impact in global health with support from USAID. Ted Prusik is a senior vice president at Temptime, a New Jersey-based company that has made a huge impact in global health with support from USAID. Credit: Temptime. Q: Temptime has a long history of working with USAID to improve global health. How did this partnership begin, and what have been some of the global health research successes you’ve achieved with USAID support? Temptime’s history is a wonderful case study on the effectiveness of US investments in efforts to solve critical global health problems. In the early 1980s Temptime, then called Lifelines, developed a unique technology that gradually changes color when exposed to time and temperature. The original idea was to use this unique chemistry for food spoilage applications. At the same time, the World Health Organization (WHO), USAID and the global health nonprofit PATH identified a pressing need to improve the effectiveness of immunization programs in the developing world. Vaccines are heat sensitive. Exposure to excessive heat can result in the loss of efficacy, leaving children who are vaccinated with heat damaged vaccines vulnerable to disease. But vaccines are stable enough to withstand some exposure to heat. Immunization program managers faced the following issues: How to better protect children from receiving a heat-damaged vaccine that was no longer efficacious? How to prevent the wastage that is common in immunization programs when health care workers presume that the vaccine is heat damaged even when it is not? USAID, WHO, and PATH recognized that the answer was a time-temperature indicator, put on each unit of vaccine, that would clearly signal when the vaccine had been exposed to a pre-determined heat load. The technology that Temptime was working to develop for the food industry was a potential solution for this application: scientifically based, predictable, easy to read, and cost effective. The application of the Temptime technology to the need identified by USAID, WHO, and PATH resulted in the development of the vaccine vial monitor, or VVM, specifically designed for oral polio vaccine. The VVM is a small circular indicator that is applied on each vial of vaccine and clearly indicates whether or not that specific vial has been exposed to excessive heat. Q: Temptime also has a notable track record of working with other partners to improve global public health. How have your partnerships with nonprofit organizations like PATH helped you to maximize investments from government agencies like USAID? The VVM is an illustration of how public-private partnerships are one of the most effective ways to deploy new technologies to support global health and how successful partnerships work. In the case of the VVM, each party brought something unique to the development. PATH, WHO, and USAID were able to clearly define the health need because of their on-the-ground presence in developing countries. From this knowledge, they were able to specify key technology requirements needed to successfully develop and deploy the VVM. Industry as a private partner could then focus its resources and capabilities on what it does best: developing and manufacturing scientifically proven, time-temperature monitoring devices. Often, while a technology exists to address the basic market need, adaptation of that technology is required to truly solve the specific global health problem. Having the knowledge of the product specifications from public sector experts on the ground—as well as the commitment to deploy the technology once it is developed—takes much of the risk away from the private sector investment. Q: Temptime products created with USAID support—like the VVM—have proven tremendously successful at saving lives and improving health worldwide. What have been some of the most notable public health benefits of the VVM? PATH estimates that between 2002 and 2012, VVMs allowed health workers to recognize and replace more than 860 million doses of overexposed vaccine and to deliver 1.45 billion more doses in remote settings—helping to save more than 150,000 lives and reduce illness for countless others. The original intent and benefit of the VVM was to ensure that vaccines overexposed to heat not be administered to children. But the introduction of this technology through the USAID/PATH/WHO/Temptime partnership has had a multiplier effect in public health programs. For example, because the VVM contributes to the effectiveness of vaccination programs, it also plays an important role in improving health outcomes and reducing health care costs. In India, for example, there are 366 million children under age 14. If 5 percent of these children received temperature-damaged vaccines that were no longer efficacious, the ongoing medical costs to treat these children for the contracted disease would exceed $1 billion annually. By contributing to the effectiveness of immunization programs, the VVM improves outcomes and frees up dollars that can be spent on other key health initiatives. Q: New tools developed for global health needs often help improve health right here at home. What have been some of the domestic health benefits of the VVM? In the case of the PATH/USAID/WHO/Temptime partnership, there were also multiple benefits to US public health. The original investment by USAID enabled Temptime to develop a technology platform that could be leveraged for other important applications. The same technology that protects children in immunization programs is used on ready-to-eat meals and rapid skin decontamination lotion for US troops. Temptime over the years has also developed new technologies that are used to support patient protection in the US. These include freeze monitoring technology used on the H1N1 vaccine in 2009, currently used in each shipment of vaccine to participating providers in the US Vaccine for Children program, as well as numerous pharmaceuticals and medical devices. Q: Temptime’s experience also demonstrates that investments in global health research and development not only help save lives around the world—they’re also a smart economic investment. What impact has USAID funding had on Temptime’s ability to create jobs, expand your business and contribute to the domestic economy? Beyond the public health benefits worldwide, new health tools and the partnerships that develop them bring benefits to US industry. In the case of Temptime, we have built a small but growing company that continues to hire and develop people. We also manufacture all of our technologies in the US and export them globally, so in our own humble way we are contributing to the improvement of the US trade deficit.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. President Barack Obama on Wednesday signed legislation into law that averts the majority of the so-called "fiscal cliff.” The law defers decisions on sequestration by two months, meaning that lawmakers will debate sequestration at the same time as they tackle a debate on the overall federal budget plans for 2013 and 2014. The law also “keeps researchers on tenterhooks for at least another two months by delaying mandatory spending cuts that could threaten science funding.” A new article examines the international military sector's role in global health activities, which "has gained visibility in recent years." According to the article, the military provides support for a range of activities, including “medical research and development to peacekeeping operations while providing normative, technical assistance, and coordinating roles.” Devex examines possible policy changes that Sen. John Kerry (D-Mass.) will bring to the State Department if confirmed as the next Secretary of State. Approvals from the US Food and Drug Administration for new drugs hit 16-year high in 2012. The agency approved 39 new drugs in 2012, including a new treatment for multi-drug resistant tuberculosis. Researchers announced that they have developed a therapeutic vaccine that can temporarily halt the growth of HIV in patients. There is an alarming rise in resistance to artemisinin in Thailand, which is currently the front-line drug in the treatment of malaria. Doctors fear it could be the start of the global spread of malaria drug resistance, underscoring the need for research into new treatments for the disease.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. During an event to mark the 25th annual World AIDS Day, President Obama announced that the National Institutes of Health will redirect some AIDS research funds to expand research to find a cure for HIV. The Drugs for Neglected Diseases initiative recently marked its 10-year anniversary with the launch of a report that looks at lessons learned from a decade of research for neglected disease treatments. A new report finds that global health disparities could be eliminated in a generation by increased investments in research for new vaccines, drugs, and other tools to combat diseases such as HIV and AIDS, malaria, and tuberculosis. Pharmaceutical company Pfizer announced that it will broaden access to information from its clinical trials to independent researchers and patients who take part in the studies. African health experts and leaders met recently to discuss the need for improved regulatory systems on the continent to monitor pharmaceutical products. A World Health Organization committee met this week to narrow down a shortlist of 24 research proposals from across the world that aim to tackle diseases that disproportionately affect low-income countries.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The European Parliament has approved Horizon 2020—the European Union's funding program for research and innovation from 2014 through 2020. The first calls for proposals are scheduled for Dec. 11, pending formal agreement from EU member states. US lawmakers are taking steps to free US Food and Drug Administration user fees from sequestration cuts. A recent congressional briefing examined progress in developing new HIV treatment and prevention tools. A new Devex article highlights efforts to ensure that health is included in the post-2015 development framework. The European Commission has invested €8.5 million in a program to reinforce the knowledge infrastructure across neglected diseases and speed the development of new global health tools like vaccines, drugs, and microbicides.