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Archive for November 2014

Science Policy Around the Web – November 28, 2014

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By: Varun Sethi, Ph.D

photo credit: El Bibliomata via photopin cc

Interdisciplinary Science

Gut-brain link grabs neuroscientists

Gut bacteria benefit mental health. Do they? This is what companies selling probiotics have long claimed. Though traditionally skeptical to the theory, many neuroscientists are becoming interested in the clinical implications of the gut microbiome. The National Institute of Mental Health spent more then US$ 1 million this year, on research aimed at studying the microbiome-brain connection. Studies presented at the recent SFN meeting in DC reported this as a paradigm shift in neuroscience. Bifidobacterium and Lactobacillus are genera that have been reported to show beneficial effects on anxiety and depression related behavior. Gut bacteria and bacterial waste products may regulate stress, anxiety and cognition, especially in early life. Mechanisms and therapeutic potential of these associations are the focus of research in the field. The interaction between the gut associated immune system, enteric nervous system and gut based endocrine system has led to intriguing speculations about the impact of the bi-directional signaling between the mind, brain and gut. Are psychobiotics and melancholic microbes going to be the prescription to happiness? Though majority of the studies are in rodent models, the implications of microbiota in our intestines is being increasingly looked at with interest. There maybe some science in the use of the term ‘gut feeling’ after all! (Sara Reardon, Nature)

 

Health Care Policy

Medicare’s Chronic Care Management Payment — Payment Reform for Primary Care

A fee-for-service system, wherein payments for primary care are restricted to office based visits, is unable to provide good support for the core activities of primary care outside the office visit. These include tasks such as patient care co-ordination, patient communication, medication refill and care provided via electronic or telephonic channels. In 2015, the Centers for Medicare and Medicaid Services (CMS) will be introducing a non-visit-based payment for chronic care management (CCM). This is an important and broadly applicable change to primary care payment and reflects an investment in creating a value-oriented healthcare system. The system will allow a practices to receive a monthly fee of $40 for beneficiaries with two or more chronic conditions, that are expected to last at least 12 months and confer a significant risk of death, decompensation or functional decline. Practices will have to use electronic health records (EHR), provide round the clock availability to staff able to access EHR and maintain a designated practitioner amongst other things. The implementation of this policy will, however, have to deal with many challenges. Beneficiaries will be expected to pay a 20% co-insurance for CCM, a fee for a service they have so far received free. They will have the choice to consent, and in the event that they refuse, how will the practice continue to care for such patients ? Smaller practices with limited resources may have trouble meeting the requirements and may perhaps be rendered ineligible. The details of the implementation are unclear as yet. While the payment will provide additional resources to the primary care system, it may not achieve the transformation in practice as per the patient-centered medical home (PCMH) initiatives. (Samuel T. Edwards, Bruce E. Landon, New England Journal of Medicine)

 

Translational Science

Changing the Mindset in Life Sciences Toward Translation: A Consensus

Basic discoveries in biomedical science continue to a fast pace, however, the translation of this knowledge into clinical use lags behind significantly. Biomedical translation is challenged with scientific, financial and political speed-breakers. In May 2014, Translate, a meeting in Berlin, brought together stakeholders from around the world with the common goal of improving biomedical translation. Infrastructure, funding and de-risking issues in biomedical technology were major factors identified as barriers in biomedical translations. An appalling 80 to 90% research projects fail before they are tested in humans, and those that do proceed require up to 15 years to find a clinical use. A multidisciplinary approach involving clinical scientists, researchers, patent agents, industrial partners and regulatory authorities is required to create expert professional translators, who have the expertise to capture those discoveries that have the potential to make it to the clinical market. A change in academic funding and education is warranted. Academic reward systems should focus on not only the publication quality, number and journal impact factor, but also on tangible impacts of research on medical treatments and patient benefits. Cross-talk between scientists from different specialties, with different ideas, perspectives and expertise needs to encouraged and facilitated. The importance of professionalizing translation was emphasized at the meeting. Adequate economic incentives and market forces are essential in driving and directing successful translation. While industry is eager to take over projects beyond phase 2, funding for early phase development is complicated by larger risks and remains an uphill task. This paper discusses the role of a translational researcher in recognizing these challenges and invoking the industry, networking to form partnerships that are essential to collect market data and find solutions. A change in scientific mindset with a greater emphasis on interactive and collaborative relationships is needed. In future articles of this series, funding barriers and derisking will be discussed. Biomedical translation, is not a passive process and is a very crucial step in improving the value of health care, health outcomes and the quality of patient life. (Duda et al., Science Translational Medicine)

 

 

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November 28, 2014 at 3:50 pm

Science Policy Around the Web – November 25, 2014

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By: Cheryl Jacobs Smith, Ph.D

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International Scientific Workforce

Updated: Science gets a nod in Obama’s immigration plans

The United States gladly welcomes foreign-trained scientists for temporary research positions, but when it comes to transitioning many of these well-trained foreign scientists to permanent positions, it is exceedingly difficult. To their chagrin many foreign-trained scientists have to leave the U.S. for more permanent positions due to the difficulty in obtaining longer-term work permits. President Barack Obama’s latest speech concerning immigration policy addressed some of these issues within the research community. His speech suggested new policy that would make it easier for foreign students studying at universities to gain temporary work permits and for Chinese and Indian researchers who already have U.S. work permits to change jobs and apply for permanent residency. The latest piece of policy provides a positive outlook for permanent job positions for those Chinese and Indian researchers who have spent countless hours in the research laboratory. However, there is still work to be done as President Obama did not state that he and his administration would increase the number of work permits for highly-skilled foreign researchers. This is indeed a problem for the high-tech industry when looking for new employees as they have complained about the chronic shortage of permits that would allow foreign highers. Additional work on this matter is the onus of the new Congress. (David Malakoff and Jim Austin, ScienceInsider)

 

The Environment

Climate Change Threatens to Strip the Identity of Glacier National Park

Although we experienced the ‘Polar Vortex’ of Winter 2014 and we may have even been buried in the latest winter storm, overall the climate change trend is towards a warmer, rather colder world. The rate of glacial melting has risen sharply since the 1980s. In the past, glaciers have come and gone, but it is more alarming given the location of these glaciers among a Rocky Mountain landscape surrounded by sprawling cities, farms, and industry. More importantly, these areas rely on more than 80% of the glacial water supply. So, what will be the result of this shrinking ice reservoir? Dr. Fagre, the resident expert on snowpacks, glaciers and climate change, says, “When that happens, this whole area will dry up a lot. A lot of these alpine gardens, so to speak, are sustained entirely by waterfalls and streams like this. And once this goes, then some of those plants will disappear.” Moisture loss from early snowmelt is worsening a record hydrological drought on the Colorado River, which supplies water to about 40 million people from the Rockies to California and Mexico; by 2050, scientists estimate, the Colorado’s flow could drop by 10 percent to 30 percent. This could lead to very passionate discussions over water rights as a growing population competes for a shrinking resource. As a nation, we are all starting to accept more and more the validity of climate change and that we are obligated to change our behavior to reduce the rate of climate change. As parts of the country will witness drought climates, other parts may be subjected to floods. Attention to water resource sharing activities and investigations into water relocation efforts may be a possible mechanism to maintain safe, water levels throughout the U.S. (Michael Wines, The New York Times)

 

Climate Change – Communication

How to Talk About Climate Change at Thanksgiving: Recipes for Good Conversations

Hopefully work is winding down and you are about to travel somewhere near or far to enjoy Thanksgiving. This holiday is unique in that the emphasis is focused on epicurean delicacies such as turkey, pumpkin pie, and mashed potatoes that draw people together in intimate scenarios. As a result, there is an overall increase in the possibility of a contentious conversation arising between individuals as they both serve up some succulent turkey with gravy. And given our current weather patterns, it will possibly be about climate change. This article outlines how to discuss climate change without sacrificing the delight of the meal and the company it keeps. The first course points out to ‘serve up questions, and not arguments’. There is so much misinformation surrounding climate change (the most popular being why is it much colder outside if the earth is warming up), it will be helpful to be able to discuss fact from fiction. The second course suggests identifying individuals that are important to the person’s values to address their concerns. For instance, if a person believes that addressing climate change will hurt the economy try to suggest an economist that has investigated that same issue. In course three, the discussion may have lead to a full-blown argument, but try to find similar solutions. Regardless if the person believes that climate change is a scientific conspiracy or not, we all want to save money on our energy costs. Try to find similar needs and desires surrounding overlapping similarities. But, do not give up discussing this important issue with family and friends. The goal is not to ‘win’ but to educate about the effects of climate change in a friendly, respectful, and calm manner. And also, to enjoy some pumpkin pie, friends, and football! So, have a happy time discussing very important issues, such as climate change, and have a happy Thanksgiving! (Aaron Huertas, The Equation blog of the Union of Concerned Scientists)

 

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November 25, 2014 at 12:00 pm

Science Policy Around the Web – November 21, 2014

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By: Elisavet Serti, PhD

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Drug Policy

Gilead pharma company will cut anti-HepC drug cost for developing countries

US drugmaker Gilead has licensed Sovaldi, its $1000-a-pill Hepatitis C drug to seven India-based drugmakers that will sell cheaper versions of the drug in 91 developing countries. Gilead has been criticized in the recent past because of the very high price of its drug ($84,000 for a complete treatment course), which excludes the majority of chronic HCV patients from receiving state of the art treatment. According to Dr. Hoofnagle, a famous NIH gastroenterologist that contributed to the establishment of the previous standard of care anti HCV treatment, a 12-week treatment course with the new combination pill against Hepatitis C genotype 1, called Harvoni from Gilead (it contains Sovaldi with one more post-anti-viral agent known as Lediparvir) reaches even higher response rates (greater than 93%), but it costs $96,000 and private insurance companies usually refuse to cover this cost. The estimated burden of anti-HepC treatment for the already overburdened US health care system will be at around $100 billion. (Aditya Kalra and Zeba Siddiqui, Reuters and Dr J. Hoofnagle’s lecture in Bethesda on 11/12/2014)

 

Federal Research Funding

The depressing burden of depression

I guess you would all agree that the modern way of life is a major factor for the increase in the cases of depression, which has now been accepted as a medical problem that needs to be treated as early as possible. According to reports, depression causes more disability than any other mental health problem (WHO. 2004) and accounts for mood changes, concentration problems and decrease in workforce productivity. Depression’s annual toll on U.S. businesses is approximately $70 billion in medical expenditures, lost productivity and other costs. Depression accounts for close to $12 billion in lost workdays each year (Wall Street Journal, 2001). Although depression is common, it is often ignored. Depressive disorders affect approximately 6.7 percent of the U.S. population age 18 and older in a given year (Archives of General Psychiatry, 2005 Jun; 62(6): 617-27). Some psychiatrists support that the high levels of undiagnosed or untreated depression would be considered scandalous for a disease such as cancer. It seems that the absence of a crisp diagnosis and the lack of understanding the mechanism of the disease development have held back therapy and research. Genetic studies have failed to define a specific genetic component, several therapeutic clinical trials have failed, and existing treatments need refinement. Redefining research agendas, raising awareness and increasing the funds towards research on depression should be priorities, especially in the era of the “BRAIN Initiative.”   (Heidi Ledford, Nature)

 

Workforce Development

PhDs outside academia: The brave ones who got away

Lots of discussion has been done lately about the future of PhD students and post Docs emerging from universities simply because there are not enough opportunities and funds in the academia to support them. Approximately 20% of Americans with science PhDs were not working in science in 2010 (nsf.gov) and less than 10% of the 86,000 current biology PhD students in the United States will become tenure-track faculty members (go.nature.com/vh1ewm). The paradox is that post Docs that are actually brave enough to accepts the facts and to leave the lab to work elsewhere are judged to have lost their focus or their “scientific drive” or to have been seduced by the dark side. Forcing a highly trained postdoc away from research is a waste of knowledge, time and money; that is why the whole research sector needs to be restructured. Universities and research institutes should stop taking advantage of the “cheap trainees” i.e. PhD students and post Docs, and more permanent research positions should be generated. These permanent employees would cost more but the labs would become smaller and far more efficient. (by Jessica Polska, ascb.org)

 

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November 21, 2014 at 12:00 pm

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Science Policy Around the Web – November 18, 2014

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By: Kaitlyn Morabito

photo credit: yui.kubo via photopin cc

Federal Science Policy

Panel considers lifting FDA ban on blood donations by gay men

Due to the rise in AIDS in the US and the association with homosexual men at the time, the FDA banned blood donations by gay men in 1985. This ban includes all men who have had sex with another man since 1977. According to the FDA, the rationale behind this ban is that men who have sex with men are at an increased risk of acquisition of HIV, Hepatitis B and other blood-borne pathogens and HIV testing of blood is not 100% accurate. However, proponents of removal of the ban emphasize that risk behavior is not taken into account. Overturning of the sexual orientation based ban is supported by the American Red Cross, AABB, and America’s Blood Centers which supply the major of blood in the US. Many other nations have removed the lifetime ban of gay men in favor of ban on men who have had sex with men within 12 months. A US Department of Health and Human Services Panel is currently debating the lifting of the ban in the US.  (Monte Morin, ScienceNow, LA Times)

 

Technology Development

U.S. to build two world-class supercomputers

The Department of Energy (DOE) is developing two new supercomputers with 4-10 fold increased computing ability up to speeds of 100-300 petaflops. The work on these supercomputers will be done in two national labs: Oak Ridge and Livermore.   The DOE have set aside $325 million for construction of two supercomputers.   In conjunction with the hardware, the DOE will apply another $100 million to software and application development through the FastForward 2 program. One of the supercomputers will be available for use by the scientific community while the other computer will mainly be utilized by National Nuclear Security Administration.   The DOE hopes that funding of these technological advances will maintain the US as a leader in technology as well as contribute to national security and the economy.  (Robert F. Service, ScienceInsider)

 

Antibiotic Resistance

Racial disparities in ear infection treatment may contribute to antibiotic overuse

A joint study by the CDC, Emory University, and the University of Utah found that black children are 30% less likely to be diagnosed with ear infections than their non-black counterparts. Of those diagnosed with ear infections, non-black children are 20% more likely to be prescribed broad-spectrum antibiotics than black children. This may indicate that black children are being under diagnosed and under prescribed or that non-black children are being over diagnosed and overprescribed antibiotics.   Regardless of the explanation, this study highlights an important discrepancy between treatment received by black and non-black children indicating a potential bias in physicians. Recently, new guidelines on antibiotic usage for otitis media were released with a focus on reduction in the use of broadspectrum antibiotics to help combat antibiotic resistance.  (Science Daily)

 

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November 18, 2014 at 12:00 pm

Science Policy Around the Web – November 14, 2014

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By: Nicholas Jury, Ph.D

Photo Credit: Lester V. Bergman/Corbis

 

Mental Health

Recent evidence linking gut microbes and mental disorders grab neuroscientists’ attention

Dietary supplement companies selling “probiotics” have often claimed that adding them to a diet can enhance the overall mental health of an individual. Even though these gut-derived microbes are readily available over-the-counter, neuroscientists are not completely sold on their utility. However, recent pre-clinical studies have provided some evidence linking mental conditions such as autism and depression to the gut microbiome. These studies have spurred new interest in the potential connection between the “gut-brain axis.”

More than $1 million has been spent this year by the National Institute of Mental Health on research projects investigating the connection between the gut microbiome and the brain. Furthermore, John Cryan at the University of College Cork in Ireland will present evidence linking gut microbes to depression-like behavior in mice at the Society for Neuroscience Annual Meeting in Washington, D.C. His study demonstrated that mice that were born via caesarean section acted in a more depressed-like manner when compared to mice that were born vaginally. “The microbiome is likely to have its greatest impact on early life,” said Cryan.

Another study conducted in mice demonstrated a potential link between autism-like symptoms and the gut microbe Bacteroides fragilis. Mice with autism-like symptoms were fed these gut bacteria and symptoms ceased. Furthermore, this same group found that the mice with autism-like symptoms had high levels of a bacterial metabolite, and that injecting this metabolite into normal mice caused them to exhibit autism-like symptoms.

These pre-clinical studies provide some evidence of the interaction between our gut microbiome and the brain, and the potential therapeutic utility of probiotics in mental health disorders.

(Sara Reardon, Nature)

 

Federal Science Policy – Regulatory

The 21st century cures initiative drums up bipartisan support on Capitol Hill

Amidst the partisan rancor and gridlock on Capitol Hill, there appears to be some resemblance of bipartisanship with a new biomedical legislative priority. The 21st Century Cures Initiative aims to reduce unnecessary regulation and decrease the time to bring new biological and pharmacological treatments to market. Specifically, the initiative could address regulation regarding clinical trials and institutional review boards. The initiative was conceived by two unlikely bedfellows on the House Energy and Commerce Committee: a conservative, Representative Fred Upton (R-MI), chairman, and a liberal Representative Diana DeGette (D-CO). The first draft of the legislation is expected to be announced at the beginning of the 114th Congress.

(Kelly Servick,  ScienceInsider)

 

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November 14, 2014 at 11:12 pm

Science Policy Around the Web – November 11, 2014

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By: Sara Cassidy, M.S., Ph.D.

Ebola

More money for the fight against Ebola

President Obama asked Congress for more than $6 billion dollars in additional funds to cope with the Ebola crisis. By framing the request as emergency funds, the president hopes to win bipartisan support for the measure. It includes $2.43 billion for the Department of Health and Human Services, much of which is apportioned for the Centers for Disease Control to shore up U.S. defense against the disease, as well as to control the epidemic in West Africa. $238 million is requested for the National Institutes for Health for vaccine and medicine development. $2.1 billion for State and international aid is slated for the U.S. Agency for International Development and USAID. Republicans indicate support for the request but also the need for careful review first. The request likely will be discussed in more detail at a Senate Appropriations hearing Nov 12th. (David Rogers, Politico)

 

Equal Pay for Equal Work

Gender inequity in pay persists in science

A recent survey conducted by the magazine, The Scientist, shines a light on the persistent inequity in pay received by equally qualified female scientists compared to their male colleagues. The difference in pay was most stunning in the U.S. and Canada, where female scientists made approximately $28,000 less than male scientists comparing average salaries. The most equitable pay was found in Latin America, where the difference in average salary was about $300. Independent of gender, the data showed that there were slight to modest increases in pay across different scientific disciplines compared to 2013, with relatively greater increases in the fields of genomics and immunology. (Jyoti Madhusoodanan, The Scientist)

 

Federal Science Policy – Climate Change

GOP majority could challenge Obama climate policy

In Tuesday’s election, Republicans gained control of the Senate and retained control of the House, which could spell disaster for the Environmental Protection Agency’s plan to cut CO2 pollution from coat-fired power plants. The GOP-lead senate has also indicated they will approve the Keystone XL pipeline, which would shuttle oil from Canada to U.S. refineries. Republican senator from Oklahoma and climate change denier, James Inhofe, is next in line to chair the Environment and Public Works Committee. (NPR)

 

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November 11, 2014 at 12:00 pm

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Science Policy Around the Web – November 7, 2014

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By: Julia Shaw, Ph.D

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Evolution

Newly discovered fossil could prove a problem for creationists

Ichthyosaurs were dolphin-like reptiles that lived during the time of the dinosaurs. These aquatic predators are thought to have evolved from land-dwelling ancestors that eventually returned to the water. Because of gaps in the fossil record, a definitive link between these proposed terrestrial reptiles and the ichthyosaur has been lacking. A study recently published in Nature identifies a semiaquatic reptile that appears to partially fill that gap. The creature, named Cartorhynchus lenticarpus, was recovered from China’s Anhui Province in 2011. Close analysis of the specimen identified C. lenticarpus as the oldest ichthysauriform identified to date. Unlike its descendant, C. lenticarpus had a shorter snout as well as large flippers, flexible wrists, and thicker bones which would have allowed them to troll shallow waters without being swept away by coastal waves. This animal lived approximately 4 million years after the earth’s largest mass extinction. Lead author of the study, Ryosuke Montani, said the amphibian “was probably one of the first predators to appear after that extinction.”  The next step? Find C. lenticarpus’ predecessor.  (Rachel Feltman, The Washington Post)

 

Ebola Outbreak – Vaccine Research

Nasal spray vaccine has potential for long-lasting protection from Ebola virus

A nasal spray vaccine developed by researchers at The University of Texas at Austin provided long-term protection in a non-human primate model after challenge with 1,000 plaque-forming units of Ebola Zaire, the strain responsible for the current outbreak in West Africa. The nasal vaccine resulted in 100 percent survival (3 out of 3 animals) 150 days post-immunization, in contrast to only 50% survival in primates vaccinated by standard intra-muscular injection. Results of the study, co-authored by Dr. Maria Croyle, graduate student Kristina Jonsson-Schmunck, and colleagues from the National Microbiology Laboratory in Winnipeg were published this week in the online edition of Molecular Pharmaceuticals. While the Ebola outbreak in West Africa continues to rage with a fatality rate as high as 70%, there remains no licensed vaccine. Officials have declared the outbreak a public health emergency. According to Jonsson-Schmunck, “There is a desperate need for a vaccine that not only prevents continued transmission from person to person, but also aids in controlling future incidents.” This is the first study to examine the longevity of an Ebola vaccine and the first to demonstrate efficacy from a single-dose, non-injectable formulation. Use of a nasal spray is preferable to needle-based vaccines in terms of both cost and safety. A Phase I clinical trial is planned to test the vaccine’s efficacy in human subjects. (ScienceDaily, Mark Prigg, MailOnLine)

 

Federal Science Policy

After Election 2014: COMPETES Reauthorization

In the coming year, Congress will likely seek to reauthorize important legislation governing research and science education. The America COMPETES Act expired last year and has yet to be extended although two different congressional committees have emerged with strikingly opposed revisions to the previous 2010 COMPETES law. Democratic Senator John Rockefeller (who has chosen to retire and will not be returning to the Senate in January) introduced S. 2757 in July. This bill seeks to make good on the 2007 and 2010 COMPETES Act by doubling the budget of the National Science Foundation (NSF), the National Institute of Standards and Technology, and the Department of Energy’s Office of Science. The increase in NSF funding would be applied to all fields of research, including the social sciences and the NSF’s current peer review system would be maintained. The bill also provides for the continuation of federal outreach and educational activities. In stark contrast, Republican Representative Lamar Smith has crafted the Frontiers in Innovation, Research, Science, and Technology (FIRST) Act. FIRST authorizes NSF programs for only 1 year with a small increase in the current budget. However, the bill also specifically allocates the funds within the foundation’s six research directorates, slashing funding for the social sciences. Smith’s bill has raised strong opposition from the scientific community who are not only pushing for a substantial, long-term budget, but are equally committed to their own peer review process for awarding research dollars. Although Republicans will control both the House and Senate come January, COMPETES may still have a fighting chance. Republican Senator Lamar Alexander, the anticipated new head of the Committee on Health, Education, Labor and Pensions, expressed support for COMPETES legislation in 2013; and fellow Republican Senator John Thune, predicted chair of the commerce and science committee, while not coming out in support of COMPETES reauthorization, has endorsed the development of a research facility in his home state of South Dakota. Regardless of whether House and Senate can agree, the White House will still play a major role in dictating policy, making a lengthy battle over reauthorization likely. (Jeffrey Mervis, ScienceInsider)

 

 

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November 7, 2014 at 12:00 pm