Statement from Research!America president and CEO Mary Woolley about AHRQ Director Carolyn Clancy’s Departure
January 31, 2013
Dr. Carolyn Clancy has been a stalwart champion of medical and health services research during her decade-long leadership at the Agency for Healthcare Research and Quality (AHRQ), stressing the importance of evidence in formulating policies to address gaps in care and improve health care delivery. She spearheaded innovative evidence-based programs to tackle some of our most challenging and complex healthcare issues. Under her leadership, AHRQ has conducted and funded research to ensure that patient care is as safe and efficient as possible, and launched the first annual report to Congress on health care disparities and health care quality. Clancy recognizes the importance of empowering patients with information to understand their health care needs and make informed decisions, and empowering health care leaders with the evidence needed to bring the right care to the right patient at the right time. She generously lent her time and expertise as a speaker at Research!America’s National Health Research Forums, joining leaders of other federal health agencies for panel discussions, and contributed to other initiatives. Hers is an important and lasting legacy.
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In November 2012, the Hudson Institute and the Global Network for Neglected Tropical Diseases released a Social and Economic Impact Review on Neglected Tropical Diseases. The report, which was the culmination of a comprehensive research and policy analysis study, outlined the economic and social impact of seven of the most common NTDs including lymphatic filariasis, onchocerciasis, trachoma, schistosomiasis, hookworm, ascariasis and trichuriasis. These diseases impose a huge economic burden by causing roughly 46-57 million years of healthy life lost due to premature death or years lived with a disability. The report also quantified the economic burden in terms of lost productivity caused by NTDs and highlighted the success of current treatment efforts. For example, trachoma, the world’s leading cause of preventable blindness, causes up to $5.3 billion in lost economic productivity each year while treatment efforts for lymphatic filariasis have saved over $24 billion in lost economic productivity.
The report argues that one of the most promising ways to treat many of these NTDs is mass drug administration (MDA), which involves treating entire populations with drugs for the seven most common NTDs. These MDA programs are also successful examples of critical public private partnerships. The combination of federal government investments in basic R&D and private sector investment in later stage R&D has produced crucial drugs that private sector companies are now donating in order to support mass drug administration programs. These public private sector collaborations, combined with investments in research and development for new tools to control NTDs, remain one of the core recommendations from the report. Research!America will continue to advocate for federal government support for R&D for NTDs and will be working with the private sector to limit the economic devastation and healthy life years lost to these diseases.
-Chris Bennet, Senior Manager of Global Health R&D Advocacy
On January 17, the Hudson Institute and the Global Network for Neglected Tropical Diseases held a briefing event to discuss their recently released report, Social and Economic Impact Review on Neglected Tropical Diseases. In addition to negative health outcomes, the report highlights the social and economic costs of these deadly diseases and argues that NTD control and elimination programs are a cost effective public health measure. For example, Michael Kremer, Gates professor of Developing Societies at Harvard University, discussed de-worming as an extremely cost effective development intervention. Several studies around the world, including in the southern United States, have shown that de-worming is worth our money and attention as it can lead to increased labor outputs, higher wages and better test scores among students.
Panelists at the event also paid tribute to many organizations that have altered the landscape of NTDs: the Rockefeller Foundation, whose campaign against hookworm has had a long standing effect in the American South and pharmaceutical company Merck & Co., who made an unprecedented commitment in 1987 to donate the drug Mectizan for as long as necessary for the control of onchocerciasis (river blindness). Other pharmaceutical companies have followed suit and drug donation programs are now being administered around the world. Of course, these programs would not be possible without collaborative partnerships between a host of public and private sector entities, from multilateral and government agencies to local on-the-ground operations. In addition to transforming the NTD landscape, lessons learned from these public private partnerships and other NTD control efforts have helped to inform other global health programs around the world.
Finally, Ellen Nagler, CEO of the END Fund, discussed the Fund’s private philanthropy model that allows the private sector to invest in NTD interventions for maximum impact. The END Fund provides capital resources and capacity to collaborate with governments and existing organizations to scale up treatments for individuals most at risk. Fifty cents per person to treat the seven diseases affecting 90% of the world’s poorest is a powerful return on investment. Nagler concluded that in order to raise the money necessary to reach our goals and eliminate these diseases, a lot more people will need to be educated about NTDs and their impact throughout the world. Please read Research!America’s summary of the report in tomorrow’s post.
-Jennifer Chow, Director of Global Health R&D Advocacy
On January 16, Uniting to Combat NTDs released “From Promises to Progress,” the first annual report on the London Declaration on NTDs. The report details the progress made by global partners that signed onto the London Declaration one year ago. Notable successes include leading pharmaceutical companies donating treatments for 100% of drug requests in endemic countries and the development of new NTD control plans in over forty countries. The past year has also seen regulatory approval for two new NTD diagnostics: a new test for lymphatic filariasis and the first rapid test for sleeping sickness developed by the Foundation for Innovative New Diagnostics.
Alongside this report, WHO also launched its second NTD report, “Sustaining the Drive to Overcome the Global Impact of Neglected Tropical Diseases.” The report targets two diseases for global eradication: guinea worm disease by 2015 and yaws by 2020. WHO also reports successes in preventive treatment, noting that 711 million people received treatment for at least one NTD in 2010 and projecting that these treatments will continue to reach more individuals in the future. However, there is still significant work to be done. Diseases like African sleeping sickness and leishmaniasis remain extremely difficult and costly to treat. There has been a 30-fold increase in dengue in the past 50 years and there is the potential for a global dengue epidemic, but we lack the appropriate tools to control and treat the virus. Whether it is scientific research to develop new drugs or operational research to develop the most effective control plans, additional investment in NTD research is crucial. Despite these challenges, Dr. Chan, Director-General of WHO, says that “the prospects for success have never been so strong.” The more we can raise awareness about these diseases that primarily affect the 1.4 billion people under poverty, the more we can do to mobilize resources for the global fight to combat NTDs. We want to make sure we continue turning prospects into actual success.
-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
This week, Boston Mayor Thomas M. Menino declared a public health emergency in the city due to a flu outbreak. City officials have confirmed 700 cases of the flu, nearly ten times the confirmed cases last year; four people have died so far. Outbreaks have been reported in other areas of the country, affecting individuals of all ages and backgrounds.
The Centers for Disease Control and Prevention recommends that the best way to prevent the flu is by getting vaccinated each year. It’s hard to imagine the dire health consequences Americans would endure without the flu vaccine, which is due in part to federal investments in research. The CDC and the Food and Drug Administration have made efforts to improve production capacity, including improving guidance about the approval process, working with manufacturers to ensure adequate supplies of vaccines are available for the general population, and researching different strains of the virus that surface each flu season.
The Influenza Genome Sequencing Project, funded by the National Institute of Allergy and Infectious Diseases, is helping researchers understand how flu viruses evolve, spread and cause disease. As of January 3, entire genetic blueprints of more than 10,000 human and avian influenza viruses taken from samples around the world have been completed. The project is helping scientists understand how influenza viruses evolve and spread, thereby keeping Americans healthy.
The best way to stay healthy this flu season is to heed to the recommendation of public health officials: Get vaccinated!
Research!America President and CEO Mary Woolley Applauds Supreme Court’s Dismissal of Embryonic Stem Cell Case
January 9, 2013
The U.S. Supreme Court’s dismissal of Sherley v. Sebelius, a case intended to block federal funding for scientists conducting embryonic stem cell research, is a victory for patients and the research community. This key decision will allow the continuation of federal funding from the National Institutes of Health, providing essential support for scientists to conduct lifesaving research. Embryonic stem cells, which can repair or replace damaged tissue and organs, have advanced research aimed at finding cures and therapies to treat a wide variety of diseases and disorders including vision impairment, spinal cord injuries, and multiple sclerosis. Clinical trials have also shown promising therapeutic applications to help fight cancer, Parkinson’s disease, diabetes and other disabling illnesses. We applaud the ruling and will continue to support such innovative research that could save millions of lives.
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The U.S. Supreme Court announced Monday that it would not hear a case that challenged the legality of federally funded human embryonic stem cell research.
The case, Sherley v. Sebelius, was brought by two researchers of induced pluripotent stem cells, James Sherley, MD, PhD, and Theresa Deisher, PhD in 2009. They argued that guidelines concerning government funding of hESC, adopted by the Obama administration, were in violation of the 1996 Dickey-Wicker Amendment. The amendment forbids the Department of Health and Human Services — including the National Institutes of Health — from using appropriated funds to either create embryos for research purposes or conduct research in which embryos are destroyed.
After an initial ruling in 2010 in favor of the plaintiffs, an injunction was issued that allowed research to continue. Eventually, both the U.S. District Court for the District of Columbia and the U.S. Court of Appeals for the D.C. Circuit found in favor of the government. The plaintiffs appealed the case to the Supreme Court, which declined to hear the case and offered no further comment in Monday’s order.
Stem cell research advocates were pleased with the ruling.
“This is a major victory for scientifically and ethically responsible innovative research,” Bernard Siegel, spokesperson for the Stem Cell Action Coalition and executive director of the Genetics Policy Institute, said in a statement. “With the cloud of this case lifted, researchers can now rest assured that the challenge to the NIH’s 2009 guidelines for funding for embryonic stem cell research is over. Patients and their advocates can now rejoice that this potentially life-saving research can proceed at the federal level.”
The ruling is “a victory for scientists, patients and the entire biomedical research community. Science can now continue to move forward, knowing the threat to promising research and funding has been eliminated,” said Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, according to ScienceInsider.
In a statement, NIH Director Francis Collins, MD, PhD, reaffirmed the agency’s dedication to ESCR.
“I am very pleased with today’s decision by the U.S. Supreme Court to decline to review the Sherley v. Sebelius U.S. Court of Appeals ruling. This decision allows the ruling to stand, and enables NIH to continue conducting and funding stem cell research, following the strict ethical guidelines put in place in 2009. Patients and their families who look forward to new therapies to replace cells lost by disease or injury, or who may benefit from new drugs identified by screening using stem cells, should be reassured that NIH will continue supporting this promising research.”
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