Kim Lufkin

Kim Lufkin, GHTC’s communications officer, writes about the coalition’s upcoming third annual policy report. The report will be launched today at a Capitol Hill briefing. Today, the GHTC will release our third annual policy report. This year’s report will continue the tradition for which we’ve become known in the world of global health research and product development—releasing recommendations for how US policymakers can continue to advance innovation and save lives around the world. The recommendations are backed by the collective voice of our strong membership of nearly 40 nonprofit groups working to advance new vaccines, drugs, diagnostics, and other products that change the course of global public health. GHTC releases policy report to provide recommendations for sustaining progress in global health research When I began the process of writing the report back in December, I initially struggled with how to make this year’s report unique. I soon realized that I didn’t need to worry on this front, as there have been several exciting research breakthroughs—such as new results from the RTS,S malaria vaccine trials and using HIV treatment as prevention—in the past year. The past 12 months have also seen some notable achievements in the realm of US policies for global health innovation. The report celebrates these successes, and urges US policymakers to maintain this recent momentum: "In recent years, the global public health landscape has seen incredible progress. Scientific leadership and a commitment to research have led to the development of game-changing innovations—including new vaccines, drugs, and diagnostic products—that are transforming global public health. Other groundbreaking health tools are closer than ever before, like the first-ever malaria vaccine,new HIV prevention options,desperately needed tuberculosis (TB) therapies,and drugs to treat neglected tropical diseases (NTDs) that affect the poorest of the poor. … US investments in global health research can produce real results, and the nation must persist in our efforts to develop the next generation of lifesaving health products.” On a more somber note, the report recognizes that the United States is facing severe economic constraints. The tight budgetary times have already impacted programs and funding for global health and research: “Today’s budget constraints mean that even the most essential programs are at risk, and over the past year, Congress has reduced funding for foreign affairs and international aid programming. Amidst these drastic cuts to broader international aid efforts, some global health and R&D [research and development] programs have seen slight increases or flat funding levels. However, these increases are not enough to make up for the huge disparity in current funding levels for global health R&D and what is actually needed to fully fund these lifesaving efforts. While support for some global health and R&D programs has modestly increased or remained flat-funded, support for other global health R&D programs—including funding for some key product development partnerships—has been severely cut.” It would be an incredible loss if widespread cuts in global health and research were to take place just as science is on the cusp of remarkable breakthroughs for new products. By following the recommendations in the GHTC’s third annual policy report, US policymakers can help take the next generation of lifesaving global health products over the research finish line. Even in this constrained fiscal environment, US leaders cannot lose sight of the end goal—saving lives worldwide. You can read the online version of the GHTC’s third annual policy report on our website.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member the Sabin Vaccine Institute has launched a new campaign, called END7. The campaign is dedicated to eliminating seven major neglected tropical diseases as a public health threat by the end of 2020. The US Food and Drug Administration (FDA) recently launched a new blog, called FDAVoice. The blog will feature posts from FDA staff on news, announcements, and other information about the work done at the agency. The US Department of Health and Human Services (HHS) has committed $1.8 million to health initiatives in Guatemala, as well as funding to support research that will look into the impact of revising the HHS regulations on human subject research. The National Institutes of Health’s newly created National Center for Advancing Translational Sciences has launched a new website. The US Patent and Trademark Office has published four proposed rulemaking implementation provisions for the America Invents Act.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member Bio Ventures for Global Health has released a new report that analyzes the engagement of different players in global health drug and vaccine development. The world invested $630.4 million in tuberculosis research and development in 2010—less than one-third of the projected $2 billion annual investment needed to eliminate the disease as a public health threat by 2050—according to a new report. While spending rose slightly by two percent since 2009, it is the smallest year-on-year increase documented. Funding from the National Institutes of Health supported more than 432,000 jobs and generated more than $62.1 billion in economic activity last year. FSG and GBCHealth look at how pharmaceutical and medical device companies can create shared value in global health by addressing unmet health needs in low- and middle-income countries.

Some of the most incredible health research is taking place in Kenya right now. Because of this work, we are on the cusp of the most exciting new tools in global public health in recent years—the first ever malaria vaccine, gels women can use to protect themselves from HIV, new drugs for neglected diseases that affect the poorest of the poor. Kenya is also rolling out an array of lifesaving new health products that research has already made available, like HIV and AIDS drugs, vaccines to protect children from pneumonia, and insecticide-treated wallpaper that prevents malaria inside people’s homes. During the GHTC’s recent trip to Kenya, I was fortunate to visit several of these global health research projects, most of them run by our dedicated coalition members like the Drugs for Neglected Diseases initiative (DNDi), PATH, the International Partnership for Microbicides (IPM), Aeras, and the International AIDS Vaccine Initiative (IAVI). We also saw firsthand how the US is making a huge impact in health research in the country, through the work of agencies like the US Agency for International Development (USAID), Centers for Disease Control and Prevention (CDC), and the Department of Defense (DoD). 3935 - Siaya, Kenya - Kayla Laserson is the Director of the KEMRI/CDC Field Research Station . Photo: Evelyn Hockstain/PATH. Although we visited a range of projects, I was left with the lasting impression that much of this research is so close to producing new health tools that can lead to amazing innovations in public health. “We are on the verge of breakthroughs in malaria and in TB and in other diseases,” Kayla Laserson, director of the CDC/KEMRI Field Research Station in Kisian, said. “What we really need is continued support so we can get the job done, we can finish it, we can show the impact, we can save hundreds of thousands of lives here and globally.” We also saw how past commitments to research are already saving lives. For example, research that led to the development of antiretroviral drugs is one of global public health’s biggest success stories. Rister Kageha, a woman living with HIV close to the town of Kakamega, told us how these drugs had not only saved her life, but also prevented her daughter Sylvia from contracting HIV. Because of these drugs, “I expect to live long,” Rister said, adding that she also hopes for a long life for Sylvia due to the drugs that kept her daughter HIV-negative. Rister Kageha says antiretroviral drugs saved her life. Photo: Evelyn Hockstein/PATH. And while past research has led to some health tools already in use, and current research is producing breakthroughs we could see in next five years, other innovations aren’t as far along down the research pipeline. This is why continued US support is critical to sustain the momentum around these new tools, from discovery to delivery. US support for microbicides, for example, has been vital to recent research successes, and must continue while the research continues over the next several years. A microbicide “is one of the tools that gives us the opportunity that we could actually end the epidemic,” Elizabeth Bukusi, deputy director at the Kenya Medical Research Institute (KEMRI) who works with IPM, said. “I think we can move towards a complete AIDS-free generation that will completely stop the epidemic in its track using microbicides as part of the armament.” She added that the “US has been a critical partner in providing catalystic funds and also in funding a large number of the trials that have looked at microbicides. So US funding is absolutely critical to moving this agenda forward.” The same can be said of US support for all global health tools, not just microbicides. Fortunately, if Kenya is any indication, the US has a long history of supporting research for health products like vaccines and drugs.This long history should not end anytime soon. It’s imperative that this historical leadership continues, so the groundbreaking research the GHTC saw in Kenya can produce the next generation of lifesaving health tools.

GHTC’s Kim Lufkin is in Kenya this week, documenting global health research projects and the impact on people in the country. This is her first post from the field. On Tuesday, our team went to visit the US Embassy in Nairobi in order to meet with some fantastic Americans working in Kenya for several US agencies, like the CDC, USAID, State Department and DoD. On the way through security, the guard pulled out the small device I constantly carry in my purse to monitor my blood glucose levels—I’ve been a Type I diabetic since age five. I realized how fortunate I am to have a quick, easy-to-use diagnostic tool that I can carry with me wherever I go. In fact, the range of testing and treatment options made available to me has grown leaps and bounds since I was a child, thanks to research and development for new diabetes products. This realization in the security line at the US Embassy stood in stark contrast to the diagnostic and treatment tools available to children in Kenya suffering from a painful and deadly neglected disease called visceral leishmaniasis, or VL. These children are in desperate need of new diagnostic and treatment tools. I remember when I was first diagnosed with diabetes at five years old, there wasn’t a fast and accurate way to monitor my glucose levels. My mom would prick my finger to withdraw blood, and then apply my blood to a small test strip. After waiting a short amount of time, she’d wipe the blood away, and the strip would change colors. She’d then have to compare the color to photos on the back of the bottle, making her best guess about what range my glucose level fell within. And the level wasn’t even current – it represented what my glucose level was several hours before—making preparing my insulin dose even that much more difficult. My mom would then have the constant battle of giving me my insulin with a syringe injection at least three times a day, which I fought tooth and nail every time. Photo: Glenn Austin/PATH This hardly compares with the process children in Kenya have to suffer through in order to determine if they have VL. On Monday, we met with Simon Bolo—an inspiring man who works with the Drugs for Neglected Diseases initiative (DNDi) in Nairobi. He told us how the only 100% accurate ways of diagnosing VL, even for children, involves incredibly painful punctures to their spleen or bone marrow. Both are conducted with giant needles required to pierce the skin and bone marrow. Children suffering from VL deserve the same commitment to research that I’ve benefited from as a diabetic in the US. Over the past 20 years, the methods available to me to test my glucose levels throughout the day have vastly improved—I now have a small machine that requires little blood and gives me accurate results in five seconds. My treatment options have also advanced, from the types of insulin available to me and the fact that I now use an insulin pump, doing away with the need for multiple injections every day. Because of these improvements, my overall health as a diabetic has improved tremendously. A matched commitment to research for neglected diseases such as VL could have the same results for children in Kenya and around the world. These children should not have to go through such painful diagnostic procedures to confirm whether they have VL—imagine if they had access to a simple, effective, and rapid blood test that they could easily access in their community’s clinic. VL affects the “poorest of the poor,” Simon told us on Monday. “Our governments need to wake up and take responsibility” for supporting research that can lead to lifesaving new tools. Children in Kenya deserve the same access to modern and effective diagnostics and treatment that I’ve has as a diabetic in the US. Increased support for neglected disease research can provide them with that.