A recently published, unexpected discovery coming from researchers at Albert Einstein College of Medicine at Yeshiva University suggests that vitamin C may be a useful component to treating drug-resistant tuberculosis. This finding may sound more like something out of a television medical drama than real life, but the research—funded by the National Institute for Allergy and Infectious Disease at the National Institutes of Health—suggests that ascorbic acid may help kill the bacteria that cause TB.
These preliminary findings have laid a foundation for clinical trials using vitamin C in tandem with other drugs. Researchers observed that vitamin C treatment of the cultured bacteria led to generation of harmful “free radicals” in both drug-sensitive and drug-resistant TB strains. It remains to be seen if vitamin C can have the same effect on the bacteria that have infected a human. Multi- and extreme-drug resistant forms of TB (MDR- and XDR-TB) are significant health threats and developing effective therapy requires the research community using every tool available. Continue reading →
On March 24, World Tuberculosis Day, the Lancet published a series of papers on the need to combat drug-resistant tuberculosis. Cases of drug-resistant TB are on the rise, posing a growing threat to the health of populations in all parts of the world.
The series consists of six papers written by international experts in the tuberculosis field, including Professor Alimuddin Zumla, Director of the Centre for Infectious Diseases at the University College London Medical School and Dr. Marco Schito at the National Institute of Allergy and Infectious Diseases. Some papers focus on TB diagnostics, highlighting advances such as the Xpert MTB/RIF test as well as the dire need for new affordable and effective diagnostics that can detect drug-resistant strains of the disease. One paper focuses on the more technical aspects of the disease and identifies the need for additional funding to research biomarkers for drug-resistant TB. Yet another paper discusses the importance of integrated health service and control efforts, as countries are facing a high burden of TB as well as non-communicable diseases such as diabetes and cancer. Finally, the last two papers discuss the importance of community engagement in research and the need for visionary political leadership to advance global efforts to control TB.
Taken together, this series not only warns of the danger of the TB, but of the danger of inaction. If we are to make progress in the global fight against TB, we must take some of the recommendations for research and control efforts laid out in these papers. It will take concerted action from political leaders, health policy makers, funders and researchers to stem the growing threat of drug resistant TB.
-Morgan McCloskey, global health intern
On February 26, the Global Health Technologies Coalition held a Capitol Hill briefing, “Renewing US leadership: Policies to advance global health research.” The briefing included displays from global health nonprofits, the launch of GHTC’s fourth annual policy report as well as a panel discussion. Panelists included Dr. Lee Hall, Chief of Parasitology and International Programs at NIAID, Dr. Alan Magill, Director of Malaria at the Gates Foundation and Dr. Caroline Ryan, Deputy Coordinator for Technical Leadership at PEPFAR. Each highlighted key U.S. contributions to global health including the development of a rapid TB diagnostic, advances in HIV/AIDS treatment and delivery through PEPFAR and a new treatment for leishmaniasis developed in part by researchers at the Department of Defense. Speakers pointed out that many of these medical breakthroughs were accomplished through leveraging U.S. government funding and working in public-private partnerships. All speakers expressed concern that cutting federal funding for global health research could jeopardize progress for these lifesaving tools.
In particular, Alan Magill warned of “breaking something that will be very difficult to put back together.” Speaker and moderator Lisa Cohen, Executive Director of the Washington Global Health Alliance, wrapped up the session citing Research!America poll data and reminding us that there is incredible support for this work – we just need to connect the dots for decision makers and funders. “78% of Americans think it is important to support global health research – we don’t think about this but when Americans are asked, it is clear that people care about these issues.”
–Morgan McCloskey, global health intern
On February 4, Aeras released the results of a clinical trial of one of their TB vaccine candidates. The trial was conducted in South Africa with nearly 3,000 infants and while the vaccine was safe and well-tolerated, ultimately it was not found to provide protection against TB. Although the results were not what researchers had hoped, the trial was the first of its kind and proved that a large-scale clinical trial to test a TB vaccine in infants can be successfully run in a country with a high TB burden like South Africa. Researchers also pointed out that there are twelve other TB vaccines in clinical development and the infrastructure built through this trial can be used to test these candidates in the future.
Instead of being disappointed with the results, the global health community must move forward in the fight against TB with renewed urgency. TB kills 1.4 million each year and over 12 million suffer from TB infection. Cases of drug-resistant TB are on the rise and the existing treatments are extremely complex and expensive, meaning that only 3% of drug-resistant patients receive proper treatment. The economic cost of TB is also enormous – in South Africa alone, TB control costs nearly $300 million each year. New drugs, diagnostics and vaccines are urgently needed to saves lives and money.
-Morgan McCloskey, global health intern
An article in the most recent issue of The Scientist highlighted the importance of affordable diagnostics for global health. Although scientific advances have improved treatment options for many global diseases, a lack of effective, low-cost diagnostics hinders the health of many in the developing world. For example, medicines to treat HIV and tuberculosis have been life-saving for many individuals, but they can cause liver damage and patients on these medications must be monitored. However, the primary test for liver damage requires expensive equipment that is simply not available in low-income countries. To solve this problem, a Massachusetts biotech company, Diagnostics For All, developed a 10 cent paper-based test that can diagnose liver damage with a single drop of blood.
Other U.S.-based companies are working on similar low-cost diagnostics. In Texas, Global BioDiagnostics Corp is developing a more effective test for tuberculosis that will cost just $5. Both of these projects are excellent models for incorporating the idea of access into the research process and designing products that can actually be utilized in low-resource settings. However, there is often not enough money for companies to develop these kinds of products. In fact, a principal investigator at PATH says that “the problem [with low-cost diagnostics] is almost always funding.” Therefore, it is crucial to increase funding for affordable diagnostics. Not only would increased investment support these U.S.-based companies, but the end products could truly transform health care in the developing world.
Update: Another article, published in The Scientist on January 10, also addresses the urgent need for better diagnostics in resource-limited countries. In addition to making diagnostics more affordable, truly successful new diagnostics must also be “sensitive, specific, user-friendly, rapid, equipment-free and deliverable” and these considerations must be built into the R&D process. Overcoming these research challenges hinges not only on additional funding, but collaboration between research companies, the healthcare industry and local governments. Several Product Development Partnerships (PDPs) are leading the charge in these kinds of innovative collaborations. For example, the Foundation for Innovative New Diagnostics (FIND), a PDP based in Geneva, Switzerland, is working with manufacturers, health organizations and ministries of health and developing diagnostics from the initial design to the operational research phase to determine the diagnostic’s efficacy in a low resource setting. The importance of these kinds of new tests, which will result in more appropriate treatment plans that can save lives and money, cannot be overlooked.
-Morgan McCloskey, global health intern
As we ring in the New Year, 2013 promises to be an exciting time to be involved in the fight to raise support and awareness for neglected tropical diseases. As the world becomes more interconnected and global warming changes disease patterns, NTDs are increasingly spreading across borders – including right here at home. For example, Slate recently published an article addressing the return of dengue in the United States. In the past few years, dengue has sickened hundreds in Florida and other southern states. Experts warn that the combination of the virus, a lack of immunity to dengue and widespread mosquitoes provide the perfect storm of conditions for larger dengue outbreaks in the U.S.
As the spread of NTDs adds urgency to the fight, scientists continue to work every day to develop innovative ideas to combat NTDs. In a trial experiment in Africa, researchers are testing the ability of prawns to combat schistosomiasis. A parasitic disease that can be fatal, schistosomiasis is spread through water snails. Prawns are the primary consumers of snails, so researchers hope that re-introducing prawns to rivers at the African test site will help decrease transmission of the disease. In addition to innovative experiments, every week there are reports of new scientific breakthroughs that will help save lives. Just last week, the FDA approved a drug to fight drug resistant tuberculosis, the first new drug for the disease in over four decades. Developed by Johnson & Johnson, the drug cures patients in less time than older treatment options. It is these kinds of innovations and breakthroughs that demonstrate the power of research investments and the importance of research for global efforts to eliminate neglected diseases. Be sure to check back soon for new NTD highlights!
–Morgan McCloskey, global health intern
On December 13 and 14, the global health community gathered at the Mount Sinai School of Medicine in New York for a conference called “Lives in the Balance: Delivering Medical Innovations for Neglected Patients and Populations.” Hosted by Mount Sinai Global Health, Doctors Without Borders (MSF), and Drugs for Neglected Diseases initiative (DNDi), the conference aimed to spur innovation for new tools to combat neglected diseases.
Several key themes emerged from the conference. First, there is a ‘fatal imbalance’ between the burden of neglected disease and medical innovations to combat these illnesses. Neglected diseases affect more than 1.4 billion people worldwide and account for nearly 11% of the global disease burden. In contrast, MSF’s Jean-Herve Bradol, MD, pointed out that of 850 new therapeutic products approved in the past decade, only 4.4% were for neglected diseases. Furthermore, only 1.4% of 148,445 clinical trials were for neglected diseases. To solve this problem, many presenters agreed that there must be a new global framework for global health R&D. A new framework would place an emphasis on public financing and some called for all countries to pledge 0.01% GDP to government-funded R&D.
In addition to reforming the global R&D system, several panelists mentioned the importance of improving access. This means not only improving access to medicines among neglected patients but improving information sharing and access to essential compounds among researchers. The idea of access must also be built into the beginning of the research process. For example, considering storage temperatures or dosage early on in the R&D process will help to ensure that the new tools being developed can be easily utilized in the field.
The conference has put a spotlight on the need for more research to combat neglected diseases. Diseases that once only existed in the developing world are becoming an increasingly large threat in Europe and in the U.S. Cases of multi-drug resistant TB are on the rise, and we need much better treatment options to cure patients. Only two drugs are currently available to treat Chagas disease; both were developed more than 35 years ago, have toxic side effects and are not effective in all patients. It is more important than ever before that governments, philanthropic groups and the private sector come together to help reform the global R&D system, improve access and find new tools to help neglected patients and populations around the world. Many have called this time, these partnerships and current innovations in modern science an unprecedented opportunity for neglected disease R&D. Others are frustrated by the seeming regression in global health due to non transformative “stopgap” efforts, citing drug resistant TB as an example. Both may be right. With unified advocacy to raise awareness and engage political and civic will for NTDs, we can successfully channel both the frustration and the opportunity ahead of us.
On Friday, September 7, at the National Institutes of Health campus, the Trans-NIH Global Health Working Group hosted a lecture titled, “Rapid, automated diagnostics for tuberculosis: a potential new benchmark.” Mark Perkins, MD, who has worked at the Global Tuberculosis Programme of the World Health Organization and is currently the chief scientific officer at the Foundation for New Innovative Diagnostics (FIND), discussed the development of a new testing method for tuberculosis.
Identified as the cause of death for 1.4 million individuals in 2010, including people in the United States, TB is a significant global health concern. However, it is consistently underdiagnosed due to inadequate and outdated testing methods. As Perkins explained, “The primary test for TB in 2004 was practically the same as the primary test for TB in 1882.”
These outdated methods could take weeks to deliver results and could not detect drug resistant strains of TB, leaving patients completely untreated or treated with the wrong drugs. With recent reports from WHO estimating that 9% of TB cases worldwide are extremely drug resistant, new methods to recognize these strains were desperately needed.
Funded in part by the National Institute for Allergy and Infectious Diseases, collaboration between FIND (a Geneva -based product development partnership involved in research for global health), California-based biotech Cepheid and the University for Medicine and Dentistry of New Jersey led to the development of a new diagnostic for tuberculosis in 2010. The test, called Xpert MTB/RIF, allows health care workers to diagnose TB and detect drug resistance in less than 2 hours. The speed and accuracy of this test allows individuals to receive appropriate treatment the very day they are diagnosed, which is critical in those parts of the world where many patients live far away from medical centers. The Xpert machine has already been implemented in several countries with remarkable success; in clinical trials, more than 95% of TB infections have been accurately identified.
In light of this success, several audience members raised questions regarding the broader applications of this diagnostic. Perkins noted that Xpert could be used as a basic model for new diagnostics to identify other strains of drug-resistant TB and possibly other diseases as well. Other audience members had questions about the feasibility of implementing this diagnostic in low-income settings. In response to an inquiry about the costliness of the test, Perkins noted that “because TB has such a high mortality rate, any successful diagnostic tool is cost effective.”
He pointed out that the U.S. government and other partners have agreed to help finance the manufacturing of this test, reducing the market price from $16.68 to $9.98 per test. Perkins emphasized that this kind of support for new diagnostics is crucial, particularly because TB tests are not the only outdated diagnostic. Although new diagnostic tools could dramatically improve treatment for several diseases, only a few private companies and PDPs are working to develop them. Continued U.S. government support for this project and R&D for new diagnostics is essential for future efforts to combat critical global health issues.
Last week, we noted the Centers for Disease Control and Prevention report about a spike in dengue cases in Puerto Rico. It’s just more evidence of what we’ve been saying all along: global health R&D matters for Americans, both in terms of health and economics.
And, this weekend, a story in the Palm Beach (FL) Post helped fortify that and another argument we make: Cutting research is not a deficit-reduction strategy.
According to reporter Stacey Singer, a CDC official warned the Florida Department of Health that Jacksonville was facing the worst tuberculosis outbreak the official had seen in two decades. But policy makers never got the message. They were too busy focusing on a restructuring – i.e., shrinking – of the Department of Health that Gov. Rick Scott (R) had signed into law only days earlier. Among that restructuring was the closing of A.G. Holley State Hospital in Lantana, located between West Palm Beach and Boynton Beach on Florida’s Atlantic coast. Holley had experience treating TB cases for more than 60 years.
Apparently unaware of the CDC report, the Department of Health mandated that Holley be closed six months ahead of schedule.
Now, as many as 3,000 people may have been in close contact with contagious people, yet only 253 have been tracked down. And TB has begun popping up in other parts of the state, including Miami.
The story notes State Rep. Matt Hudson (R-Naples) – the “champion of the health agency consolidation,” according to the story – said he too was unaware of the CDC report but promised that funding would be made available to treat those who were infected.
And it’s also left the local health department in a bind. Robert Harmon, MD, MPH, director of the Duval County Health Department, noted that in 2008, his agency had 946 employees and a $61 million budget. Today, there are 700 employees and a $46 million budget. If he can find $300,000, Harmon plans to hire experts to track down the thousands of others who may be unknowingly affected.
The story notes that a person with uncomplicated TB needs a months-long course of drugs to defeat the disease, which costs around $500. Not sticking to the course can and often does result in drug resistance.
“However,” Singer writes, “the itinerant homeless, drug-addicted, mentally ill people at the core of the Jacksonville TB cluster are almost impossible to keep on their medications.”
The cost of treating drug-resistant TB? $275,000.
Research!America’s report on sequestration detailed the devastating impact that the sequester, or across-the-board cuts that are scheduled to take place in 2013, will have on federally funded research to improve health. Now, a recent report by amfAR trains the focus of sequestration on global health.
Just as we found, amfAR reaches the same conclusion: Sequestration isn’t worth the cost.
The cuts would save $689 million — or 0.63% of the required deficit reduction for FY13. And at what cost?
- HIV/AIDS treatment for 273,000 fewer people, potentially leading to 62,000 more deaths
- Malaria treatment for 3.7 million fewer people, potentially leading to nearly 6,000 more deaths
- TB treatment for 65,000 fewer people, potentially leading to 8,000 more deaths
- Reduced funding for the GAVI Alliance, potentially resulting in 13,000 more deaths from diptheria, tetanus, pertussis, hib and hepatitis B
That’s hardly all. Besides an increase in the death rate, critical interventions will never get a chance to prevent disease: antiretroviral drugs that prevent transmission of HIV from a pregnant mother to her child and insecticide-treated nets to prevent bites from malaria-infected mosquitoes.
And that has consequences further down the line, the report notes.
“The savings achieved in across-the-board cuts in global health funding will have a negligible impact on deficit reduction,” the report states, “but will adversely affect the lives of millions of men, women and children worldwide, resulting in substantial human suffering and squandering of opportunities to build on successes in U.S. global health programming.”
Your voice can make a difference, however. Click here to contact your representatives, and tell them that sequestration is an unacceptable outcome.
amfAR is a Research!America member.