Science Policy For All

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Posts Tagged ‘Zika

Science Policy Around the Web – November 7, 2017

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By: Rachel F Smallwood Shoukry, PhD 

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Science and Society

What’s Your (Epistemic) Relationship To Science?

A recently published paper presented the results of a meta-analysis of studies that were published in the journal Public Understanding of Science. The goal of the paper was to determine whether these studies were correctly distinguishing scientific knowledge versus scientific understanding. While the exact definitions are a topic of debate in the field of epistemology, understanding of a concept is generally considered to require a deeper level of comprehension than having knowledge of a concept. This level of comprehension should allow one to draw inferences and make judgements. For the purposes of their paper, the authors set a specific definition of understanding, which included the ability to grasp “how a constellation of facts relevant to that subject are related to one another.” They found 67 papers that used the term “understanding” or similar, and compared the papers’ definitions and descriptions of understanding with their specified one. They found that only one paper defined understanding in line with their definition, and only six used it consistently without explicitly defining it correctly. Forty-seven papers were unclear about their definition of understanding, two used alternate definitions, and 11 conflated knowledge and understanding.

In a follow-up analysis, authors examined papers that were evaluating an “epistemic state”, whether the evaluation targeted the specified definition of understanding correctly. Of the 13 papers they found, only one correctly measured understanding, while two others attempted to. The two attempts and the other ten papers were more closely targeting an epistemic state that resembled knowledge than one resembling understanding.

The authors expressed concern over these findings and promote that scientists and educators think carefully about the difference between knowledge and understanding, and to be more deliberate in targeting understanding. The United States has consistently ranked behind many countries in the fields of science and mathematics. Besides the international ranking of the general population’s scientific understanding, there are other important reasons for the public to pursue understanding over knowledge. Voters elect officials who determine policy, priority, and funding of scientific concerns and research. Additionally, social media plays an increasingly prominent role in the public’s consumption of science news and information, and having a public with a better understanding of science can only help in shaping society’s actions regarding scientific discoveries and recommendations for health, environmental, technological, and social advancement.

(Tania Lombrozo, NPR)

 

Public Health

US government approves ‘killer’ mosquitoes to fight disease

The US Environmental Protection Agency (EPA) has approved the start-up company, MosquitoMate, to release lab-bred, non-biting mosquitos infected with the bacterium Wolbachia pipientis in order to infect wild mosquito populations. The goal is decrease the Asian tiger mosquito population by releasing infected males which will then create nonviable progeny with wild females. The Asian tiger mosquito can transmit diseases such as dengue, yellow fever, West Nile Virus, and Zika. The EPA has approved the release of these mosquitos in 20 states plus Washington, DC, stating that the approved states have climates similar to those in the regions where MosquitoMate performed test trials.

The biggest obstacle MosquitoMate faces presently is production time; males must be separated from the females, and the company currently separates them both by hand and mechanically. Improvement is possible, however, proven by the research team from Michigan State University and Sun Yat-sen University in China who release millions of mosquitoes infected with the same bacterium weekly in China. They mechanically separate the males and females with 99% accuracy.

Another company using lab-altered mosquitoes to fight wild mosquitoes, Oxitec, has hit resistance in the US. Although widely used in Brazil, voters in Florida were wary of releasing the genetically modified mosquitoes into the wild. People seem to fear the unanticipated consequences of having a large population of GM organisms on the loose. MosquitoMate has appeared to avoid much of this controversy due to the distinction of their mosquitoes being infected with a common bacterium in insects, rather than being genetically engineered. There has been little attention to MosquitoMate’s activities in trial areas, and most of the feedback has been positive. The company will begin by selling their mosquitoes locally and then expanding to nearby areas and beyond as they are able to boost production

(Emily Waltz, Nature News).

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November 7, 2017 at 5:21 pm

Science Policy Around the Web – September 12, 2017

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By: Saurav Seshadri, PhD

Vaccination Medicine Vaccine Ampoules

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Infectious Diseases

Is a Zika vaccine worth the effort?

A collaboration between pharmaceutical giant Sanofi and the US Army to develop a vaccine for the Zika virus has come to an end.  About a year ago, Sanofi received $43.2 million in funding from the Biomedical Advanced Research and Development Authority (BARDA, a division of DHHS) to move a Zika vaccine candidate, generated by the Walter Reed Army Institute of Research, into Phase II development.  BARDA has now decided to ‘de-scope’ the project, leading Sanofi to abandon its efforts to develop or license the candidate.

The number of cases of Zika has declined sharply since its peak in early 2016.  While this ‘evolving epidemiology’ has hampered Zika-related clinical research and drug development, it may actually be a welcome relief for Sanofi. The French company has endured months of political pressure to agree to pricing assurances for any vaccine produced from the collaboration, with lawmakers, including Senator Bernie Sanders, arguing that it would be a ‘bad deal‘ for a private company to profit from research funded in part by American taxpayers.  In particular, the exclusivity of Sanofi’s license,  uncommon for such agreements, has been singled out as ‘monopolistic’.  Sanofi has been defending itself vigorously against this characterization, pointing out that it took on significant risk itself for a vaccine that was far from approval, and that it has already discussed reimbursing the US government for its investment through milestone and royalty payments.  Ultimately, ending the collaboration puts this PR-damaging debate to rest, while also providing Sanofi a face-saving opportunity to avoid committing to a drug with limited prospective demand and profitability (as recently transpired with the dengue fever vaccine Dengvaxia, which only reached 55 of its projected 200 million euros in sales in 2016).

In its statement, Sanofi says that it continues ‘to believe that public-private partnerships are the right model to address…public health challenges’ posed by infectious diseases.  Indeed, several pharmaceutical companies responded to the WHO’s declaration of Zika as a public health emergency in 2016; of these, Takeda and Moderna appear to still have ongoing large-scale collaborations with BARDA to develop Zika vaccines.  While the drop in Zika prevalence is clearly a good thing, it’s unclear how it will affect the economic and scientific feasibility of such collaborations in the future.  One solution is to promote vaccine development before an outbreak occurs: groups such as the Coalition for Epidemic Preparedness Innovations (CEPI) hope to facilitate this approach, but the need to allocate limited resources makes its practicality questionable.  However, the alternative is usefully illustrated by the Ebola epidemic of 2014.  Despite concerted global efforts that led to successful vaccine development by Merck, current outbreaks are small enough that the deployment of vaccines may not even be warranted.  Barring an overhaul of regulatory processes and/or financial priorities, it seems likely that when the next epidemic emerges, we’ll be playing catch-up again.

(Eric Sagonowsky, FiercePharma)

Neuroscience

Is every human brain study a clinical trial?

Basic research into the mechanisms underlying cognition and their impairment in a range of brain disorders is the primary focus of hundreds of neuroscience laboratories.  While such studies feed into drug discovery for diseases such as autism, schizophrenia, and bipolar disorder, since they do not directly involve testing any treatments, they are not commonly considered to be clinical trials.  This perception became technically incorrect in 2014, following an NIH announcement broadly redefining ‘clinical trial’ to include any study in which ‘one or more human subjects’ receive an intervention and ‘health-related biomedical or behavioral outcomes’ are observed.  Last year, the NIH revised its data reporting policies for such trials.  These more stringent policies are now being implemented, and will affect grant applications submitted in 2018.

Several members of the scientific community have begun to voice their concern about the changes.  The Association for Psychological Science (APS) and Federation of Associations in Behavioral & Brain Sciences (FABBS) have both sent critical letters to the NIH. A petition by neuroscience researchers pushing back against the policy has garnered over 3,400 signatures.  Opponents argue that the requirements imposed by the ‘clinical trial’ label are overly burdensome and would impede basic research.  These requirements include timely study registration and public disclosure of results through ClinicalTrials.gov. Further, they demand that all staff receive Good Clinical Practices training. Investigators dread the bureaucracy that will be involved in complying with these mandates.  Perhaps most concerning for scientists is the constraint that new proposals must respond to a Funding Opportunity Announcement, which have specific stipulations about study objectives, design, oversight, and evaluation.  While these rules are intended to promote scientific rigor and transparency, the more immediate effects may be to stifle exploration and creativity and to deter basic researchers who may not know how to tailor their applications to reflect clinical values.

For its part, the NIH is steadfast that the broad redefinition is ‘intentional’ and that current standards of data reporting are ‘unacceptable’.  Policymakers argue that they are simply asking scientists to inform the public about the existence and outcome of their research.  While this sounds unimpeachable in theory, scientists are already reporting practical challenges: for example, asking potential study participants to sign a clinical trial consent form can scare them away.  While the NIH is making efforts to provide guidance to the community, it is running out of time to stamp out confusion before next January, let alone achieve enthusiastic compliance.  Neuroscientists are likely to face setbacks in funding and progress as a result.

(Sara Reardon, Nature News)

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September 12, 2017 at 5:52 pm

Science Policy Around the Web – August 22, 2017

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By: Leopold Kong, PhD

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Image: By Tkarcher [CC BY-SA 4.0], via Wikimedia Commons

Zika

The case of the disappearing Zika

Early last year, there were over 35,000 suspected and confirmed cases of Zika virus infection per week in South America. This year, the number has plummeted below 1,000 per week. In the United States, only a single case of local Zika transmission has been reported this year in contrast to 224 in 2016.  Neither improved mosquito control nor climate change can explain the good news.  Experts attribute the drop in Zika cases to the development of immunity against the virus, which has spread rapidly.  Anthony Fauci, director of the National Institute of Allergy and Infectious Disease (NIAID), says he is not “entirely surprised” by this trend, but is “impressed by how steep it has been”.  A vaccine is still needed to curb potential future epidemics, but its development is now complicated by lack of populations susceptible to infection.  Increased Zika cases have been reported in Mexico this year, which could lead to outbreaks in Texas. Currently, a vaccine developed by NIAID is entering a placebo-controlled study of 2400 people in Zika-affected areas.

(Jon Cohen, Science)

The Scientific Workforce

Graduate Student immigration in the US and the UK shifting to Canada and Australia

In 2015-16, the United States and United Kingdom hosted nearly 384,000 and 200,000 international graduate students respectively. The two countries have been the world’s top two hosts for graduate students since the 1970s.  However, since the travel ban in the United States and the Brexit referendum in the United Kingdom, the numbers have been dropping.  In contrast, universities in Canada and Australia are reporting spikes in their application numbers.  Joint surveys conducted in February and July found that about a third of US universities have decreased international graduate student applications, particularly from India, the Middle East and China.  Sayed Mashaheet, a native of Egypt who earned his PhD in crops science at North Carolina State University, says that many international students see the United States as a riskier investment since the election.  With its friendly citizenship pathways, Canada maybe benefiting from these changes. The University of Toronto received 27% more international-student applications this year for a total of 15,000 compared to 11,951 in 2016.  Sofia Solar Cafaggi chose to pay her way through medical school at the University of Toronto instead of attending the Cleveland Clinic in Ohio for free because she will be eligible for Canadian citizenship after three years.  “In the US, I would have stayed an alien for at least the next decade, and that made me nervous about career prospects given the current political drama,” she says.  If the shift continues for the US and the UK, “some programmes will simply collapse,” says Anita Gopal, international officer for the US national Postdoctoral Association in Rockville, Maryland.

(Virginia Gewin, Nature News)

Science Funding

Trump’s list of Science Priorities aims to steer federal agencies’ focus

On August 17, the White House issued a memo to federal agencies outlining how their research money should be used.  Written jointly by the White House Office of Management and Budget and Office of Science and Technology Policy, the document sets the White House’s priorities for the next budget request.  This year, the memo lists five priorities in this order: military superiority, security, prosperity, energy dominance, and health.  The list greatly contrasts with Obama’s research priorities that included global climate change, clean energy, Earth observations, advanced manufacturing, and innovations in the life sciences, biology and neuroscience.  The list also appears to contradict President Trump’s own 2018 budget requests.  For example, the memo focuses on support for breakthroughs in military technologies and for helping older Americans remain healthy despite large cuts for those same areas in previous proposals.  Notably, the memo supports research in precommercial technology in energy, which would presumably include the Department of Energy’s Advanced Research Projects Agency-Energy.  However, President Trump has previously called for this agency to be shut down.  The budget for the 2019 fiscal year are due next  month.

(Jeffrey Mervis, Science)

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August 22, 2017 at 5:36 pm

Genetically Modified Animal Vectors to Combat Disease

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By: Sarah L Hawes, PhD

Mosquito larvae: ©ProjectManhattan via Wikimedia Commons

Diseases transmitted through contact with an animal carrier, or “vector,” cause over one million deaths annually, many of these in children under the age of five. More numerous, non-fatal cases incur a variety of symptoms ranging from fevers to lesions to lasting organ damage. Vector-borne disease is most commonly contracted from the bite of an infected arthropod, such as a tick or mosquito. Mosquito-borne Zika made recent, regular headlines following a 2015-2016 surge in birth defects among infants born to women bitten during pregnancy. Other big names in vector-borne disease include Malaria, Dengue, Chagas disease, Leishmaniasis, Rocky Mountain spotted fever and Lyme.

Vaccines do not exist for many of these diseases, and the Centers for Disease Control (CDC) Division of Vector-Borne Diseases focuses on “prevention and control strategies that can reach the targeted disease or vector at multiple levels while being mindful of cost-effective delivery that is acceptable to the public, and cognizant of the world’s ecology.” Prevention through reducing human contact with vectors is classically achieved through a combination of physical barriers (i.e. bed nets and clothing), controlling vector habitat near humans (i.e. dumping standing water or mowing tall grass), and reducing vector populations with poisons. For instance, the Presidential Malaria Initiative (PMI), initiated under President Bush in 2005, and expanded under President Obama, reduces vector contact through a complement of educating the public, distributing and encouraging the use of bed nets, and spraying insecticide. Now a 600 million dollar a year program, PMI has been instrumental in preventing several million Malaria-related deaths in the last decade.

But what if a potentially safer, cheaper and more effective solution to reduce human-vector contact exists in the release of Genetically Modified (GM) vector species? Imagine a mosquito engineered to include a new or altered gene to confer disease resistance, sterility, or to otherwise impede disease transmission to humans. Release of GM mosquitos could drastically reduce the need for pesticides, which may be harmful to humans, toxic to off-target species, and have led to pesticide-resistance in heavily-sprayed areas. Health and efficacy aside, it is impossible to overturn or poison every leaf cupping rainwater where mosquitos breed. GM mosquitos could reach and “treat” the same pockets of water as their non-GM counterparts. However, an insect designed to pass on disease resistance to future generations would mean persistence of genetic modifications in the wild, which is worrisome given the possibility of unintended direct effects or further mutation. An elegant alternative is the release of GM vector animals producing non-viable offspring – and this is exactly what biotech company Oxitec has done with mosquitos.

Oxitec’s OX513A mosquitos express a gene that interferes with critical cellular functions in the mosquitos, but this gene is suppressed in captivity by administering the antibiotic tetracycline in the mosquitos’ diet. Release of thousands of non-biting OX513A males into the wild results in a local generation of larvae which, in the absence of tetracycline, die before reaching adulthood. Release of OX513A has proven successful at controlling mosquito populations in several countries since 2009, rapidly reducing local numbers by roughly 90%. Oxitec’s OX513A line may indeed be a safe and effective tool. But who is charged with making this call for OX513A and, moreover for future variations in GM vector release?

Policy governing use of genetically modified organisms must keep pace with globally available biotechnology. Regulatory procedures for the use of GM vector release are determined by country, and there is a high degree of international policy alignment. The Cartagena Protocol on Biosafety is a treaty involving 170 nations currently (the US not included) that governs transport of “living modified organisms resulting from modern biotechnology” with potential to impact environmental or human health. The World Health Organization (WHO) and the Foundation for the National Institutes of Health (FNIH) published the 2014 guidelines for evaluating safety and efficacy of GM mosquitos.

Within the US, the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology was published this January in response to a solicitation by the Executive Office of the President for a cohesive report from the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and US Department of Agriculture (USDA). Separately, biotech industry has been given fresh guidance on whether to seek FDA or EPA approval (in brief):  if your GM product is designed to reduce disease load or spread, including vector population reduction, it requires New Animal Drug approval by FDA; if it is designed to reduce pest population but is un-related to disease, it requires Pesticide Product approval by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act.

Thus, for a biotech company to release GM mosquitos in the US with the intent of curbing the spread of mosquito-borne disease, they must first gain FDA approval. Oxitec gained federal approval to release OX513A in a Florida suburb in August 2015 because of FDA’s “final environmental assessment (EA) and finding of no significant impact (FONSI).” These FDA assessments determined that the Florida ecosystem would not be harmed by eliminating the targeted, invasive Aedes aegypti mosquito. In addition, they affirmed that no method exists for the modified gene carried by OX513A to impact humans or other species. Risks were determined to be negligible, and include the accidental release of a few, disease-free OX513A females. For a human bitten by a rare GM female, there is zero risk of transgene transfer. There is no difference in saliva allergens, and therefore the response to a bite, from GM and non-GM mosquitos. In addition, as many as 3% of OX513A offspring manage to survive to adulthood, presumably by spawning in tetracycline-treated water for livestock. These few surviving offspring will not become a long-term problem because their survival is not a heritable loop-hole; it is instead analogous to a lucky few mosquitos avoiding contact with poison.

Solid scientific understanding of the nature of genetic modifications is key to the creation of good policy surrounding the creation and use of GMOs. In an updated draft of Guidelines For Industry 187 (GFI 187), the FDA advises industry seeking New Animal Drug Approval to include a molecular description of the intentional genetic alteration in animals, method for alteration, description of introduction to the animal, and whether the alteration is stable over time/across generations if heritable, and environmental and food safety assessments. Newer genomic DNA editing techniques such as CRISPR offer improved control over the location, and thus, the effect of genetic revisions. In light of this, the FDA is soliciting feedback from the public on the GFI 187 draft until April 19th, 2017, in part to determine whether certain types of genetic alteration in animals might represent no risk to humans or animals, and thus merit reduced federal regulation.

Following federal clearance, the decision on whether to release GM vectors rests with local government. Currently, lack of agreement among Florida voters has delayed the release of OX315A mosquitos. Similar to when GM mosquito release was first proposed in Florida following a 2009-2010 Dengue outbreak, voter concern today hinges on the perception that GM technology is “unproven and unnatural.” This illustrates both a healthy sense of skepticism in our voters, and the critical need to improve scientific education and outreach in stride with biotechnology and policy. Until we achieve better public understanding of GM organisms, including how they are created, controlled, and vetted, we may miss out on real opportunities to safely and rapidly advance public health.

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February 16, 2017 at 9:46 am

Containing Emerging and Re-emerging Infections Through Vaccination Strategies

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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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January 26, 2017 at 9:47 am

Science Policy Around the Web – November 22, 2016

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By: Rachel Smallwood, PhD

Photo source: pixabay

Federal Research Funding

US R&D Spending at All-Time High, Federal Share Reaches Record Low

Recently released data from the National Science Foundation (NSF) showed trending increases in scientific research funding in the US across the past several years. Estimates of the total funding for 2015 put the value at an all-time high for research and development (R&D) funding for any country in a single year. In 2009, President Obama stated a goal to devote 3% of the USA’s gross domestic product (GDP) to research, and we have been making slow progress to that point; in 2015, 2.78% of the GDP went to research. Businesses accounted for the largest portion of overall scientific funding, contributing 69% of the funds. The second largest contributor was the federal government; however, it had the lowest percentage share of the total since the NSF started tracking funding in 1953, and the actual dollar amount contributed has been declining since 2011. Therefore, although the overall percentage of GDP going to research is increasing, that increase is driven by businesses, whereas the GDP percentage contributed by the federal government has dropped to almost 0.6%.

When taking a closer look at types of research, the federal government is the largest funding source for basic science research, covering 45% of the total. However, businesses make up the majority of the funding for applied research (52% in 2014) and experimental development (82% in 2014). This disproportionality in funding types combined with the decreases in federal research spending are concerning for the basic science field. There is more competition for less money, and this concern is compounded by uncertainty and questions about President-Elect Trump’s position on and plans for scientific funding. Aside from a couple of issues, primarily concerning climate change and the environment, he has said very little about science and research. Many scientists, institutions, and concerned citizens will be watching closely to see how science policy develops under Trump’s administration and its effects on federal spending and beyond. (Mike Henry, American Institute of Physics)

Biomedical Research

‘Minibrains’ Could Help Drug Discovery for Zika and for Alzheimer’s

A group of researchers at Johns Hopkins University (JHU) is working on a promising tool for evaluating disease and drug effects in humans without actually using humans for the tests. ‘Minibrains’ are clusters of human cells that originated as skin cells, reprogrammed to an earlier stage of development, and then forced to differentiate into human neural cells. They mimic the human brain as far as cell types and connections, but will never be anywhere near as large as a human brain and can never learn or become conscious.

A presentation earlier this year at the American Association for the Advancement of Science conference showcased the potential utility for minibrains. A large majority of drugs that are tested in animals fail when introduced in humans. Minibrains provide a way to test these drugs in human tissue at a much earlier stage – saving time, money, and animal testing – without risking harm to humans. Minibrains to test for biocompatibility can be made from skin cells of healthy humans, but skin cells from people with diseases or genetic traits can also be used to study disease effects.

A presentation at the Society for Neuroscience conference this month demonstrated one such disease – Zika. The minibrains’ growth is similar to fetal brain growth during early pregnancy. Using the minibrains, Dr. Hongjun Song’s team at JHU was able to see how the Zika virus affected the cells; the affected minibrains were much smaller than normal, a result that appears analogous to the microcephaly observed in infants whose mothers were infected with Zika during the first trimester.

Other presentations at the meeting showcased work from several research groups that are already using minibrains to study diseases and disorders including brain cancer, Down syndrome, and Rett syndrome, and plans are underway to utilize it in autism, schizophrenia, and Alzheimer’s disease. Though there might be a bit of an acceptance curve with the general public, minibrains potentially offer an avenue of testing that is a better representation of actual human cell behavior and response, is safer and more affordable, and reduces the need for animal testing. (Jon Hamilton, NPR)

Health Policy

A Twist on ‘Involuntary Commitment’: Some Heroin Users Request It

The opioid addiction epidemic has become a significant healthcare crisis in the United States. Just last week the US Surgeon General announced plans to target addiction and substance abuse. He also stated the desire for a change in perception of addiction – it is a medical condition rather than a moral or character flaw. Earlier this year, the Centers for Disease Control published guidelines that address opioid prescribing practices for chronic pain, strongly urging physicians to exhaust non-pharmacologic options before utilizing opioids. In response to the rising concern over prescription opioid abuse, steps have been taken to reduce prescriptions and access. This has resulted in many turning to heroin – which is usually a cheaper alternative anyway – to get their opioid fix.

One of the first steps in treatment and recovery for addiction and dependence is detoxing. However, opioids are highly addictive and many people struggle with the temptation to relapse. Additionally, many of the programs designed to help with the initial detox have long wait lists, are expensive, and may not be covered by insurance, further deterring those with addiction and dependence from getting the help they need. These factors have caused many to start turning to their states, asking to be voluntarily committed to a program on the basis that they are a danger to themselves or others because of their substance abuse. This is currently an option in 38 states. These programs can be held in either privately-run institutions or in state prisons. However, this practice is controversial because if the person’s insurance does not cover their stay, it falls to tax payers to foot the bill. While this is unpopular with some, advocates say the civil commitment laws are important options while there may be no other immediate ways for an individual to get help. (Karen Brown, NPR)

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November 22, 2016 at 9:00 am

Science Policy Around the Web – November 15, 2016

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By: Sarah Hawes, PhD

Source: PHIL

Zika

Florida voters weigh in on GM mosquito releases: What are the issues?

Concern over mosquito-borne Zika virus arriving in the United States this year spurred rapid allocation of resources toward identifying solutions. Clinical trials are just beginning for a traditional, attenuated vaccine while parallel efforts include research into injecting small DNA segments to effectively vaccinate by engaging a patient’s own cells to produce harmless, Zika-like proteins. However the risk of severe birth defects in infants born to Zika infected mothers is a powerful incentive for expediency. One answer exists in the use of genetically modified (GM) mosquitos to reduce vector number by breeding them in the wild. In August, the Food and Drug Administration (FDA) agreed for the first time to release of GM mosquitoes in the U.S.

The GM mosquitos in question are almost exclusively non-biting males of the Zika vector species Aedes aegypti, modified by British biotech company Oxitec, to carry a gene that prevents their offspring from reaching sexual maturity. Oxitec has used similar techniques successfully since 2009 in the Cayman Islands, Malaysia, Brazil, and Panama. A document prepared by the FDA Center for Veterinary Medicine examines myriad concerns, and determines program risks to be negligible. It includes ecosystem reports showing lack of predators reliant on the invasive Aedes aegypti, and explains that no recognized method exists for the genome-integrated transgene to impact or spread among other species. However a small percentage of GM mosquitos survive to adulthood and could transfer modified genes (or transgene resistance) to next-generation Aedes aegypti. In addition, some fear that population reduction among one disease-carrying mosquito species will make way for another, such as Aedes albopictus, which is also capable of carrying Zika, Dengue, and Chikungunya.

On Election Day, the final word on whether or not to release Oxitec GM mosquitos was given to voters living in the proposed release-site in the small peninsula neighborhood of Key Haven, Florida, and in surrounding Monroe County. Countywide, 58 percent of voters favored release. Within Key Haven, 65 percent opposed it. Following this divide, the decision now rests with Florida Keys Mosquito Control Board. (Kelly Servick, Science Insider)

HIV Vaccine

Controversial HIV vaccine strategy gets a second chance

The first participants in a $130 million HIV vaccine study, funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID) and the Bill & Melinda Gates Foundation, received injections last week in South Africa. The study is a modified repetition of a study conducted in Thailand seven years ago that used nearly three times the number of participants and reported a modest 31.2% risk reduction through vaccination. In a nation with 6 million HIV positive persons, this would still be valuable if reproduced, but there is concern that alterations in the vaccine intended to boost efficacy could have the opposite effect.

No mechanism has been found for the vaccine’s efficacy in Thailand, making it hard to improve on. In hopes of extending the duration of protection, twice the amount of an HIV surface protein will be given. A canary-pox virus carrying pieces of HIV virus common in Thailand seven years ago (targets on which to hone the body’s immunity) has instead been loaded with strains common in South Africa. Finally, a stronger immune stimulant, or “adjuvant,” is included in the injection. However, in May, a study by National Cancer Institute vaccine researcher Genoveffa Franchini found that monkeys were protected from HIV by the old but not by the new adjuvant. Franchini suggests that the new adjuvant may even leave vaccinated persons more susceptible to infection. The South Africa study leader Glenda Gray says that Franchini makes a “compelling” argument for adding a group to repeat use of the old adjuvant, if more money can be found.

The enormity of South Africa’s AIDS epidemic (18% of global cases) compels empathy for the perspective held by Gray, who said, “Someone has to put their stake in the ground and have the courage to move forward, knowing we might fail.” At the same time one would hope that the use of $130 million in HIV research funds is being fueled more by quality medical science than by desperation and action-bias. (Jon Cohen, Science Magazine)

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Written by sciencepolicyforall

November 15, 2016 at 9:45 am