Posts Tagged ‘infectious diseases’
Science Policy Around the Web May 6, 2021
By Patience Kiyuka, PhD
Covid-19 vaccines: Should we allow human challenge studies to infect healthy volunteers with SARS-CoV-2?
Human challenge trials are experiments in which healthy individuals are deliberately infected with a pathogen under controlled conditions. Researchers use this model to closely study the progression of a disease or potential treatment in a level of detail not available in traditional field studies. Such studies have been instrumental in defining “correlates of protection” or biological indicators of who is protected from infection and how this protection is mediated. This is because of the precise timing of infection and the ability to measure immune response at pre-determined time points in the course of an infection. Much of what is known today about respiratory syncytial virus, influenza and malaria comes from such human challenge trials. In Feb 2021, the UK government became the first to approve the COVID-19 human challenge trial, stirring controversy on whether these studies are promising. A UK study announced in April 2021 will be a human challenge trial on COVID-19 reinfection. A BMJ article published recently argues on the pros and cons of such studies.
Such studies are needed
As of Dec 2020, there were over 300 candidate vaccines at different stages of testing. Typically, vaccines are first tested in mice before systematically moving to humans. Human challenge studies could be used to determine which of these numerous candidates should be prioritized. Even though we have vaccines against COVID-19 in the market, some argue that human challenge trials are still useful in guiding the development of second or third-generation vaccines.
There are also risks involved
Those against COVID-19 challenge studies argue that the risks are too uncertain and too great to be allowed. Unlike clinical trials where patients are treated, sometimes in human challenge studies, healthy individuals are infected solely for scientific ends. With remaining unknowns about COVID-19, is it worth the risks? Several people have already enrolled in the UK trial, and the scientific community is waiting to see what the study will reveal. The ethical clearance by the UK government for the challenge trial is likely to be a precedent for other countries, and such studies may be here to stay.
(Seán O’Neill McPartlin, Josh Morrison, Abie Rohrig, Charles Weijer, BJM)
Science Policy Around the Web January 15, 2021
By Maria Disotuar, MPH, PhD
A New Coalition Forms to Make Digital Vaccine ID Cards A Reality
The COVID-19 pandemic forced the shutdown of major global economies, and since the beginning of this crisis, leaders and experts have debated over the best approaches to reopen the shattered global economy. Now that vaccination efforts are underway, several health and tech companies have formed a coalition to develop vaccination ID’s or vaccination passports called SMART health cards. The coalition is called the Vaccination Credential Initiative (VCI) and is made up of tech and health giants like Microsoft, Oracle, Salesforce and the Mayo Clinic.
The health cards will allow individuals to maintain a digital encrypted copy of their immunization records in a digital wallet such as the Apple Wallet. The health cards will be used to confirm that an individual has been vaccinated against the virus and allow entry to public events and/or spaces. Long-term it will serve the same role as the vaccination booklets that help individuals keep track of their travel vaccines. Paul Mayer, the CEO of the non-profit The Commons Project which is also a VCI partner, noted that the goal is to not only re-open the economy but provide individuals with the opportunity to “safely return to travel, work, school, and life while also protecting their data privacy.” Individuals without phones will be able to maintain the record on a paper QR code.
Although a concrete timeline for the rollout has not been determined, individuals are voicing ethical concerns. The primary being whether states can impose restrictions on individuals who refuse to be vaccinated and what exceptions will need to be made by private employers who will make vaccinations a requirement. R. Alta Charo, a bioethicist at the University of Wisconsin at Madison notes that there will have to be exceptions for individuals with disabilities or those that cannot be vaccinated due to health or religious reasons. Despite these concerns, Mayer notes that VCI is already working with major airlines and hotels, and is hoping to roll out the program within the next few months. The US is not the only country working to implement this type of vaccination registry. Governments across the globe are working to implement systems that will rapidly determine if an individual has been vaccinated. The hope is for the world to return to normal even though the word “normal” will have to be redefined.
(Leah Rosenbaum, Forbes)
Science Policy Around the Web – July 3rd, 2019
By Neetu Gulati, Ph.D.
The US opioid epidemic is driving a spike in infectious diseases
Opioid use has skyrocketed in the US in the past 20 years, and addiction kills tens of thousands of people each year. Now, opioid use has been linked to an increase in infectious diseases as well, which may pile on to an already extreme public health concern.
One cause for concern is that opioids themselves may be making people more susceptible to infection, though the reason for this is unclear. One study found that people treated at veterans’ health facilities who took medium or high doses of prescribed opioids for pain management were more susceptible to pneumonia, for example. Another cause for concern is that unsafe injection practices may mean that users of illicit opioids could lead to an increase of infections. Bacterial infections, such as those caused by Staphyloccocus aureus, can enter the bloodstream of opioid users through non-sterile needle usage or unclean sites of injection. If these bacteria reach the heart, it can lead to damage and possibly the need for a transplant. For example, a study done in North Carolina found a tenfold increase in heart infections among drug users in the state over a 10-year period.
As if the increase in infections was not bad enough, another major challenge is that the pattern of outbreaks associated with drug use may not be the same as that of non-drug-affiliated outbreaks, meaning it is difficult to predict where and when infections might occur. Furthermore, as Georgiy Bobashev, a data scientist at RTI International, pointed out, drug users “don’t have good practices and they don’t have good connections with people who have been injecting drugs for a long time.” In tackling the problem, it will be important to consider the social component of predicting outbreak patterns among drug users. It will also be important to treat opioid use as a disease without stigmatizing drug users, commented Carlos Del Rio, a global-health researcher at Emory University.
(Sara Reardon, Nature)
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Science Policy Around the Web – March 18, 2017
By: Joel Adu-Brimpong, BS
By James Tourtellotte, CBP Today [Public domain], via Wikimedia Commons
Public Health Policy
Missing the Brush Strokes while Gazing at the Bigger Picture
Last Wednesday, the House Committee on Education and the Workforce approved a little-advertised bill called HR 1313, or the genetic testing bill, with partisan-line voting (all 22 republicans in favor and all 17 democrats opposed). Overshadowed by the highly publicized, contentious debate over the Affordable Care Act repeal-and-replace efforts, this bill has remained largely undetected by the media as it traverses congress. This genetic testing bill would not only enable employers to require their employees to undergo genetic testing but also allow employers access to the genetic information, according to an article by STAT news. Employees refusing such requests could be at risk for thousands of dollars in penalties.
Current legislation, including the Americans with Disabilities Act (ADA) and the 2008 Genetic Information Nondiscrimination Act (GINA), prohibit such authority by employers, preventing requests by employers for “underwriting purposes”, which include “basing insurance deductibles, rebates, rewards, or other financial incentives on completing a health risk assessment or health screenings.” Additionally, genetic information provided to employers must be de-identified and aggregated to protect individual identities.
The HR 1313 bill would circumvent current legislation by nullifying these protections as long as the genetic test requests are part of “workplace wellness programs.” Employers purport that the ADA and GINA are “not consistent with the well-established and employee protective wellness program regulatory framework under HIPAA.” They argue that the House bill will aid in aligning the ADA and GINA with laws about workplace wellness programs. Conversely, experts including Jennifer Mathis, director of policy and legal advocacy at the Bazelon Center for Mental Health Law, and Nancy Cox, president of the American Society of Human Genetics, have come out against the bill. In an opposition letter to chairwoman Representative Virginia Foxx (R-N.C.), and ranking member, Robert Scott, of the U.S. House Committee on Education and the Workforce, critics of the bill state that “Workplace wellness programs are fully able to encourage healthy behaviors within the current legal framework: they need not collect and retain private genetic and medical information to be effective. Individuals ought not to be subject to steep financial pressures by their health plans or employers to disclose their own or their families’ genetic and medical information.” Nonetheless, with the possibility of such infringement, we remain lost in the bigger debate surrounding Affordable Care Act repeal-and-replace efforts with little regard for subtle components like HR 1313. (Sharon Begley, STAT news)
Infectious Diseases
Here We Go Again? The Re-emergence of Yet Again, Another Arbovirus
The recent resurgence of arboviruses, or ARthropod-BOrne viruses, in the Americas is concerning. While the 1990’s saw the reemergence of Dengue and the West Nile, Chikungunya resurfaced in 2013 and, recently, Zika in 2015. With South and Central America and the Caribbean still reeling from the reemergence of these viruses, another arbovirus appears to be making a comeback. Over the past weeks, a fifth arbovirus has been detected. Per a perspective piece co-authored by Dr. Anthony Fauci, infectious disease expert and director of the National Institute of Allergy and Infectious Diseases, there are on-going outbreaks of yellow fever in Brazil.
As of February 2017, there have been 234 reported cases and 80 confirmed deaths, with many other infections pending investigation. In context, the number of reported cases currently exceeds previously observed rates of infection for this time of the year. Regionally, the reported cases appear localized to rural areas in southeastern Brazil, chiefly Sao Paulo, Espirito Santo and Minas Gerais. According to the article, current cases appear to be “sylvatic” or jungle cases, with transmission occurring primarily between forest mosquitoes and non-human primates. Thus far, there is no evidence to suggest human-to-human transmission via the infamous Aedes aeqypti mosquito. Humans currently serve as “incidental hosts.” However, the propinquity of the affected areas to major urban centers in Brazil, where routine coverage of yellow fever vaccination is low, is alarming.
Experts posit that the likelihood of spread to the continental United States is low. However, they caution, “In an era of frequent international travel, any marked increase in domestic cases in Brazil raises the possibility of travel-related cases [anywhere].” A particularly poignant example in the article is the December 2015 large urban yellow fever outbreak in Angola and subsequent spread to the Congo. This led to an exhaustion of the world’s emergency supply of vaccines for epidemic response, “prompting health authorities to immunize inhabitants in some areas using one fifth of the standard does in order to extend vaccine supply.” Amidst these critical times of global health crises, threatened cuts to U.S. global health support will likely be catastrophic for developing nations. (Madison Park, CNN)
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Containing Emerging and Re-emerging Infections Through Vaccination Strategies
By: Arielle Glatman Zaretsky, PhD
Source: CDC [Public Domain], via Wikimedia Commons
Throughout history, humans have sought to understand the human body and remedy ailments. Since the realization that disease can be caused by infection and the establishment of Koch’s postulates, designed to demonstrate that a specific microbe causes a disease, humans have sought to identify and “cure” diseases. However, while we have been successful as a species at developing treatments for numerous microbes, viruses, and even parasites, pure cures that prevent future reinfection have remained elusive. Indeed, the only human disease that has been eradicated in the modern era (smallpox) was eliminated through the successful development and application of preventative vaccines, not the implementation of any treatment strategy. Furthermore, the two next most likely candidates for eradication, dracunculiasis (guinea worm disease) and poliomyelitis (polio), are approaching this status through the use of preventative measures, via water filtration and vaccination, respectively. In fact, despite the recent pushback from a scientifically unfounded anti-vaxxers movement, the use of a standardized vaccination regimen has led to clear reductions in disease incidence of numerous childhood ailments in the Americas, including measles, mumps, rubella, and many others. Thus, although the development of antibiotics and other medical interventions have dramatically improved human health, vaccines remain the gold standard of preventative treatment for the potential of disease elimination. By Centers for Disease Control and Prevention [Public domain], via Wikimedia Commons
Recently, there have been numerous outbreaks of emerging or reemerging infectious diseases. From SARS to Ebola to Zika virus, these epidemics have led to significant morbidity and mortality, and have incited global panic. In the modern era of air travel and a global economy, disease can spread quickly across continents, making containment difficult. Additionally, the low incidence of these diseases means that few efforts are exerted to the development of treatments and interventions for them, and when these are attempted, the low incidence further complicates the implementation of clinical trials. For example, though Ebola has been a public health concern since the first outbreak in 1976, no successful Ebola treatment or vaccine existed until the most recent outbreak of 2014-2016. This outbreak resulted in the deaths of more than 11,000 people, spread across more than 4 countries, and motivated the development of several treatments and 2 vaccine candidates, which have now reached human trials. However, these treatments currently remain unlicensed and are still undergoing testing, and were not available at the start or even the height of the outbreak when they were most needed. Instead, diseases that occur primarily in low income populations in developing countries are understudied, for lack of financial incentive. Thus, these pathogens can persist at low levels in populations, particularly in developing countries, creating a high likelihood of eventual outbreak and potential for future epidemics.
This stream of newly emerging diseases and the re-emergence of previously untreatable diseases brings the question of how to address these outbreaks and prevent global pandemics to the forefront for public health policy makers and agencies tasked with controlling infectious disease spread. Indeed, many regulatory bodies have integrated accelerated approval policies that can be implemented in an outbreak to hasten the bench to bedside process. Although the tools to identify new pathogens rapidly during an outbreak have advanced tremendously, the pathway from identification to treatment or prevention remains complicated. Regulatory and bureaucratic delays compound the slow and complicated research processes, and the ability to conduct clinical trials can be hindered by rare exposures to these pathogens. Thus, the World Health Organization (WHO) has compiled a blueprint for the prevention of future epidemics, meant to inspire partnerships in the development of tools, techniques, medications and approaches to reduce the frequency and severity of these disease outbreaks. Through the documentation and public declaration of disease priorities and approaches to promote research and development in these disease areas, WHO has set up a new phase of epidemic prevention through proactive research and strategy.
Recently, this inspired the establishment of the Coalition for Epidemic Preparedness Innovations (CEPI) by a mixed group of public and private funding organizations, including the Bill and Melinda Gates Foundation, inspired by the suggestion that an Ebola vaccine could have prevented the recent outbreak if not for the lack of funding slowing research and development, to begin to create a pipeline for developing solutions to control and contain outbreaks, thereby preventing epidemics. Instead of focusing on developing treatments to ongoing outbreaks, the mission at CEPI is to identify likely candidates for future outbreaks based on known epidemic threats and to lower the barriers for effective vaccine development through assisting with initial dose and safety trials, and providing support through both the research and clinical trials, and the regulatory and industry aspects. If successful, this approach could lead to a stockpile of ready-made vaccines, which could easily be deployed to sites of an outbreak and administered to aid workers to reduce their morality and improve containment. What makes this coalition both unique and exciting is the commitment to orphan vaccines, so called for their lack of financial appeal to the pharmaceutical industry that normally determines the research and development priorities, and the prioritization of vaccine development over treatment or other prophylactic approaches. The advantage of a vaccination strategy is that it prevents disease through one simple treatment, with numerous precedents for adaptation of the vaccine to a form that is permissive of the potential temperature fluctuations and shipping difficulties likely to arise in developing regions. Furthermore, it aids in containment, by preventing infection, and can be quickly administered to large at risk populations.
Thus, while the recent outbreaks have incited fear, there is reason for hope. Indeed, the realization of these vaccination approaches and improved fast tracking of planning and regulatory processes could have long reaching advantages for endemic countries, as well as global health and epidemic prevention.
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Biosurveillance: Can We Predict And Prevent Infectious Disease Outbreaks?
By: Teegan A. Dellibovi-Ragheb, PhD
The increasing frequency and scope of infectious disease outbreaks in recent years (such as SARS, MERS, Ebola and Zika) highlight the need for effective disease monitoring and response capabilities. The question is, can we implement programs to detect and prevent outbreaks before they occur, or will we always be reacting to existing outbreaks, trying to control the spread of disease and mitigate the harm to people and animals?
In some cases, the science suggests that we can predict the nature of the public health threat. For instance, scientists at the University of North Carolina at Chapel Hill identified a SARS-like virus, SHC014-CoV, that is currently circulating in Chinese horseshoe bat populations. This virus is highly pathogenic, does not respond to SARS-based therapies, and can infect human cells without the need for adaptive mutations. Furthermore, there are thought to be thousands of related coronaviruses in bat populations, some of which could emerge as human pathogens. These findings suggest that circulating SARS-like viruses have the potential to cause another global pandemic, and resources need to be dedicated to surveillance and the development of more effective therapeutics.
What is biosurveillance?
In 2012 President Obama released the first-ever National Strategy for Biosurveillance, whose purpose is to better integrate the many disparate governmental programs and non-governmental organizations that collect and monitor public health data. The Strategy defines biosurveillance as “the process of gathering, integrating, interpreting, and communicating essential information related to ‘all-hazards’ threats or disease activity affecting human, animal, or plant health to achieve early detection and warning, contribute to overall situational awareness of the health aspects of an incident, and to enable better decision making at all levels”. The “threats” described by the Strategy include emerging infectious diseases, pandemics, agricultural and food-borne illnesses, as well as the deliberate use of chemical, biological, radiological and nuclear (CBRN) weapons.
The overall goal of the Strategy is “to achieve a well-integrated national biosurveillance enterprise that saves lives by providing essential information for better decision making at all levels”. This goal is broken down into four core functions: (1) scan and discern the environment; (2) identify and integrate essential information; (3) inform and alert decision makers; and (4) forecast and advise potential impacts.
How are these programs implemented?
A number of programs were launched in response to President Obama’s Strategy. For instance, USAID’s Emerging Pandemic Threats (EPT) program created four complementary projects (Predict, Prevent, Identify, and Respond) which together aim to combat zoonotic outbreaks in 20 developing countries in Africa, Asia and Latin America that are hotspots of viral evolution and spread. Predict focuses on monitoring the wildlife-human interface to discover new and reemerging zoonotic diseases. The Prevent project aims to mitigate risk behavior associated with animal-to-human disease transmission. Identify works to strengthen laboratory diagnostic capabilities, and Respond focuses on preparing the public health workforce for an effective outbreak response.
There are many other agencies besides USAID and the State Department that participate in biosurveillance and biosecurity, including the Department of Health and Human Services (through the Biomedical Advanced Research and Development Authority). The Department of Defense and the Department of Homeland Security both have biosecurity programs as well (the Defense Threat Reduction Agency and the National Biodefense Analysis And Countermeasures Center, respectively). These focus more on protecting the health of armed forces and combatting deliberate acts of terror, however there is still a lot of overlap with emerging infectious diseases and global health. A comprehensive disaster preparedness strategy requires coordination between agencies that may not be used to working together, and who have very different structures and missions.
What are the challenges?
Global disease surveillance is a critical aspect of our biosecurity, due to accelerated population growth and migration, and worldwide movement of goods and food supplies. Political instability, cultural differences and lack of infrastructure in developing countries all present obstacles to effective global biosurveillance. These are complex issues, but are critically important to address, as rural populations in low- and middle-income countries can become hotspots of infectious disease outbreaks. This is in part due to the lack of sanitation and clean water, and the close contact with both domestic and wild animals.
Another challenge is determining the most effective metrics with which to monitor public health data. Often by the time a new pathogen has been positively identified and robust diagnostic measures implemented, a disease outbreak is well under way. In some cases, the actions of health workers can make the situation worse, such as in the tragic mishandling of the 2010 cholera outbreak in Haiti by the United Nations. One approach that has been shown to be effective for early detection is the use of syndromic surveillance systems, such as aggregating data from emergency room visits or the sale of over-the-counter medication. When combined with advanced computing techniques and adaptive machine learning methods this provides a powerful tool for the collection and integration of real-time data. This method can alert public health officials much earlier to the existence of a possible outbreak.
Scientific research on high-consequence pathogens is a key aspect of an effective biosecurity program. This is how we develop new diagnostic and therapeutic capabilities, as well as understand how pathogens spread and evolve. However, laboratories can also be the initial source of an infection, such as the laboratory-acquired tularemia outbreak, and research with the most dangerous pathogens (Select Agent Research) must be carefully monitored and regulated. It has been an ongoing challenge to balance the regulation of Select Agents with the critical need to enhance our scientific understanding of these pathogens. Of particular concern are gain-of-function studies, or Dual Use Research of Concern (DURC). From a scientific standpoint, these studies are vital to understanding pathogen evolution, which in turn helps us to predict the course of an outbreak and develop broad-spectrum therapeutics. However this also poses a security risk, since it means scientists are deliberately increasing the virulence of a given pathogen, such as the experimental adaptation of H5N1 avian influenza to mammalian transmission, which could pose a significant public health threat if deliberately misused.
How well are we doing?
The International Security Advisory Board, a committee established to provide independent analysis to the State Department on matters related to national and international security, published a report in May of 2016 on overseas disease outbreaks. They make a number of recommendations, including: (1) better integration of public health measures with foreign policy operations; (2) working with non-governmental organizations and international partners to increase preparedness planning and exercises; (3) increase financial support and reform structural issues at the World Health Organization to ensure effective communication during crises; (4) bolster lines of communication and data sharing across the federal government, in part through the establishment of interagency working groups; and (5) strengthening public health programs at the State Department and integrating public health experts into regional offices, foreign embassies and Washington for effective decision making at all levels.
The RAND Corporation, an independent think tank, conducted a review of the Department of Defense biosurveillance programs. They found that “more near-real-time analysis and better internal and external integration could enhance its performance and value”. They also found funding to be insufficient, and lacking a unified funding system. Improvements were needed in prioritizing the most critical programs, streamlining organization and governance, and increasing staff and facility resources.
RAND researchers also published an article assessing the nation’s health security research. They found that federal support is “heavily weighted toward preparing for bioterrorism and other biological threats, providing significantly less funding for challenges such as monster storms or attacks with conventional bombs”. In a study spanning seven non-defense agencies, including the National Institutes of Health (NIH) and the Centers for Disease Control (CDC), they found that fewer than 10% of federally funded projects address natural disasters. This could have broad consequences, especially considering that natural disasters such as earthquakes, hurricanes or tornadoes can create an environment for infectious diseases to take hold in a population. More work needs to be done to integrate biosurveillance and biosecurity programs across different agencies and allocate resources in a way that reflects the priorities laid out by the administration.
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Science Policy Around the Web – December 9, 2016
By: Amy Kullas, PhD
Vaccination via photopin (license)
Infectious Diseases
Current Mumps Outbreak is the Worst in Recent History
2016 has been the worst in recent history for mumps outbreaks. According to a report released by the Center for Disease Control (CDC), almost 4,000 cases of mumps have been reported. This number is almost triple the number of cases reported in 2015. Mumps symptoms include: puffy cheeks and a swollen jaw (due to swollen salivary glands), fever, headache, tiredness, and loss of appetite.
In prevention of mumps, the measles, mumps, and rubella (MMR) vaccine is ~88% effective when a person gets both of the recommended doses and ~78% effective when a person received a single dose. The mumps vaccination program began in 1967. Prior to this, mumps was considered a ‘classical’ childhood disease in the United States. Some clinicians say, “the efficacy of the vaccine wanes after 10 to 15 years.”
Though mumps outbreaks can still occur in vaccinated communities (particularly in close-contact settings like colleges), high vaccination rates aids to limit the size, length, and spread of the outbreak. This ongoing outbreak is hard-hitting college campuses. In fact, some universities have scaled back dining hall hours in addition to asking students to “cancel nonmandatory social gatherings” in an attempt to thwart the infectious disease. Other universities have begun to recommend and offer a third dose of the mumps vaccine to students. (Melissa Korn, The Wall Street Journal)
Vaccination
Andrew Wakefield, the orchestrator of the “anti-vaccine movement”, met with Donald Trump this past summer. This misguided movement began with a paper published in 1998 by the now discredited Wakefield in The Lancet. The authors claimed that 2/3 of children developed autism soon after receiving the measles, mumps, and rubella (MMR) vaccine. Though this study has been disproven numerous times and has been retracted, the impact still flows not only through the scientific community, but also into the general public. This is why the scientific community cringed when Trump appeared to be sympathetic towards their cause.
When parents refuse to vaccinate their children, they cite the belief that vaccines cause autism or state that vaccines are “unnecessary”. Vaccination is an extremely effective strategy for preventing infectious diseases. However, this strategy is only successful when the vast majority of individuals are immunized against a particular pathogen in order to offer some protection to individuals who are not medically able to receive the vaccine.
Wakefield stated, “For the first time in a long time, I feel very positive about this, because Donald Trump is not beholden to the pharmaceutical industry. He didn’t rely upon [drug makers] to get him elected. And he’s a man who seems to speak his mind and act accordingly.” While Trump has appeared to be interested and open-minded on vaccines, there are limits to what he can do to undercut vaccination policies. But the antivaxers remain hopeful that Trump will be a powerful ally who would trigger more of a cultural impact as opposed to passing laws. (Rebecca Robbins, STAT news)
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Science Policy Around the Web – June 17, 2016
By: Eric Cheng, Ph.D.
Photo source: pixabay.com
Biomedical Research Funding
NIH gets $2 billion boost in Senate spending bill
The Senate approved a $2 billion dollar boost to the National Institutes of Health (NIH) budget for the 2017 fiscal year. This will increase the agency’s overall budget to $34 billion which represents a 6.2% increase from the previous year. This boost in funding represents an increase to NIH’s funding for the second year in a row after more than a decade of stagnate funding. NIH received an additional $2 billion last year.
The increase to NIH’s funding is the result of bipartisan negotiations between Senate Labor, Health and Human Services, and Education Appropriations Subcommittee Chairman Roy Blunt (R.-Mo.) and Ranking Member Senator Patty Murray (D-Wash.)
“Last year, for the first time in 12 years, we were able to have an increase in [funding to support] NIH research,” Blunt said at a subcommittee meeting to unveil the budget proposal. “We have worked hard to repeat that this year.” Adding that he hopes to establish a pattern of increases for health research funding, he further noted that “if you are going to have an annual pattern, year two is critical. So we’re proposing for the second year in a row we make a substantial commitment to NIH research.”
The bill will include $1.39 billion for Alzheimer’s disease research, a $100 million increase for Obama’s Precision Medicine Initiative, an additional $100 million for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) brain-mapping project, and $50 million in new spending for a federal initiative to combat antimicrobial resistance. Not mentioned is the $670 million proposal for Vice President Joe Biden’s proposed moonshot to double progress against cancer. (Jocelyn Kaiser, ScienceInsider)
Federal Accountability
House sharpens oversight of new NSF facilities
The U.S. House of Representatives approved bill H.R. 5049 by a vote of 412 to nine which would direct the National Science Foundation (NSF) to audit its major multi-user research facilities. This bill was passed in response to the problems that have plagued NSF’s National Ecological Observatory Network (NEON) under construction at dozens of sites across the country. Last December NSF fired the contractor, NEON Inc., citing a potential $80 million cost overrun and continued delays in completing the project.
The passage of the NSF Major Research Facility Reform Act of 2016 would direct the NSF to audit its major multi-user research facilities in order to prevent such cost overrun problems in the future. The Congressional Budget Office estimates that conducting these audits required by the legislation would cost about $2 million annually and $10 million over the 2017-2021 period. Specifically, the bill would require NSF to analyze how much every large research project would cost by the first year of the start of construction.
NSF officials remain concerned on how these changes in legislation would affect how audits are conducted and the use of management fees for a contractor. Such additional restrictions on management fees could potentially scare off some highly qualified would-be bidders for future projects. In addition, they believe that the proposed audits would not have caught the problems that NEON faced. (Jeffrey Mervis, ScienceInsider)
Infectious Diseases
Zika virus added to the FDA Priority Review Voucher Program Act
U.S. Senators Amy Klobuchar (D-Minn.) and Al Franken (D-Minn.) supported emergency funding to help stem the spread of the Zika virus in the United States. Over $1 billion in emergency funds passed the Senate today on a bipartisan basis to help mitigate the spread of Zika and respond to outbreaks of the virus.
“The Zika virus is a real threat, and we need action to curtail its spread and encourage the development of treatments and a vaccine,” said Franken. “This emergency support will help fight back against the disease, and now, we need to work with the House of Representatives and with President Obama to make sure that the funding measure becomes law. This is far too important of an issue to ignore.”
The Centers for Disease Control has reported that over 150 pregnant women in the U.S. have been diagnosed with Zika virus, which can cause a range of birth defects including devastating neurological defects. There are currently no known treatments or vaccines for the disease. The funds will be used to control mosquitos that carry the Zika virus, raise awareness of Zika virus disease, provide education on how to reduce risk of becoming infected, and accelerate development of a vaccine. (Congressional Research Service)
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Science Policy Around the Web – November 3, 2015
By: Danielle Friend, Ph.D.
Photo credit: photo credit: Grandfather Healing via photopin (license)
Healthcare Costs
Costs for Dementia Care Exceed Most Other Diseases
A recently study examining the cost of care for individuals suffering from dementia found that the cost of this care is exceeding the cost for caring for those that die from heart disease or cancer. In addition to costing more, the new study also reports that out-of-pocket spending for these patients and their families is 81 percent higher than for people without the disease and suggests that the economic burden is higher for individuals with dementia if the patient is black, has less than a high school education, or is widowed or unmarried. The study used data from Medicare recipients who died between 2005 and 2010 and found that the average cost for caring for these patients was $287,038 compared to $175,136 for those who died from heat disease or $173,383 for those who died from cancer. The increased costs for caring for an individual with dementia have been attributed to the fact that these individuals often require care for many years, that there are currently no treatments that effectively slow the disease, and that the care is not covered by insurance. For example, Medicare does not cover homecare service and non-rehabilitative nursing care, support often need for those with dementia. Additionally, individuals with dementia often need constant supervision as well as assistance with everyday activities such as eating, dressing, and bathing – again, care that is costly but not covered by Medicare. Certainly as the Baby Boomer population nears their elderly years concerns for how individuals pay for this much needed care will increase. (Gina Kolata, New York Times; Tara Bahrampour, Washington Post)
International Scientific Community
Canadian Scientists have High Hopes for Increased Government Support Following Election
Prior to Canada’s Election Day on October 19th, Canadian scientists made a rare push for federal science funding to be an issue in the elections. The Professional Institute of Public Service of Canada, a union made up of 15,000 scientists, aired radio ads accusing the governing Conservative Party of not supporting scientists. However, with the ousting of the Conservative Party, which had held power for nearly 10 years and the election of Canada’s Liberal Party to a majority government led by Justin Trudeau, Canadian scientists are looking to the future with higher hopes for science. Since taking hold of leadership in 2006, the Conservative Party had eliminated the position of the national science adviser, a position that the Liberal Party states they will restore. Additionally, the Conservative Party was also accused of ending climate and environment science programs and closing research libraries in government departments, as well as placing a greater emphasis on applied industrial research which left basic science lacking resources. In Canada, government support for science research is particularly important because private industry contributes proportionally less to research compared to other countries. If commitments are upheld by the new Liberal Party, Canadian scientists hope a new era of Canadian science will see a bright future. (Brian Owens, ScienceInsider)
Infectious Diseases
Ebola Virus Appears to be Long-Lived
As the number of new cases of Ebola appears to be dwindling, researchers are startled by new findings that the Ebola virus may leave traces in survivors that could contribute to new epidemics. Although researchers have known since 1999 that Ebola virus could be found in the semen of male survivors for months, new work published in The New England Journal of Medicine demonstrate that in 93 Ebola virus survivors, Ebola viral RNA could be found in semen samples from 46 men up to 9 months after contacting Ebola. Additionally, a second paper details the sexual transmission of the Ebola virus to a Liberian woman. The paper indicates that there were no cases of Ebola in the 30 days prior to the woman being diagnosed, however she reported having unprotected vaginal intercourse with an Ebola survivor prior to being diagnosed in March 2015. The male survivor had Ebola in September of 2014 but had tested negative in October 2014. However, a semen sample taken from the man in March tested positive for Ebola. Much more work will need to be done to definitely determine whether Ebola can be sexually transmitted and for how long after the survivor has recovered. The original articles detailing these findings can be found here and here.
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Science Policy Around the Web – October 21, 2014
By: Jennifer E. Seedorff, Ph.D.
Ebola Outbreak – Public Health
In the US, fear spreads faster than Ebola
Ebola is a scary, lethal virus. Luckily, “There’s a reason it’s not everywhere. It’s just not as easy to transmit as people think.” said CDC epidemiologist, Michael Kinzer. So far, the only people to become infected while living in the US are two health-care works that treated the initial patient while he was having severe symptoms, including vomiting and diarrhea. In Ebola, the amount of virus in the body is not the same throughout the course of the infection. As the disease progresses, the amount of Ebola virus present in the body and bodily fluids increases dramatically. Since Ebola is transmitted through direct contact with bodily fluids, individuals without symptoms are not contagious despite being infected with Ebola. However, fears of Ebola have led to what some believe to be overreactions, including a cruise ship that was turned away from port or a school that temporarily closed because an employee had traveled on a different flight that used the same airplane as an Ebola infected health-care worker. As Kinzer told the Guinea media this summer, “Ebola’s not transmitted by the air. Fear and ignorance are transmitted by the air.” (Joel Achenbach and Brady Dennis, Washington Post)
Infectious Diseases
US pauses new funding for controversial virus research
The White House has announced that it is pausing any funding for new Gain-of-Function studies on viruses, like influenza, MERS, or SARS, and has called for a voluntary moratorium on existing research projects. Gain-of-Function studies have been controversial both inside and outside the scientific community. These types of studies seek to understand what kinds of mutations are necessary for a virus to evolve to become more pathogenic or to be more easily transmitted in humans or mammels. Proponents argue that these studies help in pandemic planning and strategies for vaccine development. Opponents argue that these studies are generating viruses that have the potential to cause a pandemic if accidentally or intentionally released from the labs. Concerns have been elevated due to recent concerns over safety at high-level containment research labs. US policy for determining the risk/benefits and approval process for these types of gain-of-function will be evaluated by both the National Science Advisory Board for Biosecurity and by the National Academy of Sciences over the next year. (Jocelyn Kaiser and David Malakoff, ScienceInsider)
Cancer Research – Precision Medicine
Cancer Immunotherapy successful in Phase I/IIA clinical trial
Cancer Immunotherapy is a promising precision medicine approach for treating cancer, and was named Science magazine’s breakthrough of the year in 2013. In a recent study, cancer immunotherapy was shown to be an effective treatment for acute lymphoblastic leukemia, a cancer of B-cells. This treatment worked well in patients who had failed traditional therapies, including some whose cancer had previously returned even after stem cell transplants. This study reported impressive, durable results six months after therapy, with 23 of 30 patients alive, 19 of 30 in complete remission, and with 15 of 30 receiving no additional therapy. In this particular version of cancer immunotherapy, a patient’s own T-cells were harvested, then genetic bits of information are added to their T-cells to help them recognize B-cells (which are the source of the cancer), the modified T-cells are given back to the patient, and then these genetically modified T-cells hunt and kill the cancerous B-cells. As with any therapy, this treatment does have side effects most, including destruction of healthy B-cells and Cytokine release syndrome, a systematic inflammatory response that can cause a high fever, a drop in blood pressure, and difficulty breathing. This study was published in the New England Journal of Medicine and was partially sponsored by Novartis which holds the license to develop this therapy. In July, the FDA designated this engineered T-cell treatment as a “breakthrough therapy” which should help expedite the development and regulatory review of this therapy. (Denise Grady, New York Times)
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