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Science Policy Around the Web – February 21, 2017

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By: Rachel Smallwood, PhD

Obesity

Should We Treat Obesity Like a Contagious Disease?

Researchers are modeling obesity from a public health perspective as a contagious disease. There are many factors associated with obesity, including genetics, low levels of physical activity, and high caloric intake. An earlier study examined the effects of different social factors on an individual’s risk of being obese; it found that people with obese friends and family were at an increased risk for obesity, and this trend was influenced by how close the relationships were.

In this model of the prevalence of obesity, the researchers included a factor to represent obesity as a “social contagion”, reflecting those previous findings and indicating a potential increased risk and increased prevalence due to transmission from one person to another. This mechanism is assumed to be related to people adopting the behaviors of those close to them; notably, activity levels and type and quantity of food consumed. The model predicts obesity rates in populations with terms associated with the genetic contribution to obesity, the mother’s non-genetic contribution to her offspring, and the prevalence of obesity. Essentially, the more obese individuals there are in a society, the more likely it is for someone to know and interact with an obese person.

The models indicate that obesity prevalence plateaus around 35-40% without an intervention. The model is still fairly primitive, but the researchers hope that in future it could provide insight into the effects of potential interventions. For example, is it better to target an intervention to individuals who are already obese, or should the reach of the intervention be more broad and target the population as a whole? When the models reach a level of complexity comparable to the existing factors for obesity, they can be a powerful tool in preventing and addressing the epidemic. (Kelly Servick, Science Magazine)

Autism

Brain Scans Spot Early Signs of Autism in High-Risk Babies

A study recently published in Nature showed that alterations in brain development in children who go on to be diagnosed with autism precede behavioral symptoms. High-risk infants’ brains were scanned with MRI at 6, 12, and 24 months. It was determined that the infants who were subsequently diagnosed with autism had a faster rate of brain volume growth between 12 and 24 months. Additionally, between 6 and 12 months, these infants had a faster rate of growth in the surface area of folds on the brain, called the cortical surface.

Taking these findings, the research team used a machine learning approach called a deep-learning neural network to make a model to predict whether an infant would be diagnosed with autism based on their MRIs from 6 and 12 months. This model was tested in a larger set of infants, and the model correctly predicted 30 out of 37 infants who went on to be diagnosed (true positives), and it incorrectly predicted that 4 infants would be diagnosed with autism out of the 142 who were not later diagnosed (false positives). These results are much more robust than behavior-based predictions from this same age range.

More work needs to be done to replicate the results in a larger sample. Additionally, all of the participants were high-risk infants, meaning they had a sibling who was diagnosed with autism, so the results are not necessarily generalizable to the rest of the population. Further studies need to be done in the general population to determine if these same patterns are observable, but that would require an even larger sample due to the lower risk. However, the early detection of symptoms and prediction of diagnosis are potentially valuable tools, especially considering another recent publication showed that early intervention in children with autism affects the severity of symptoms years down the road. (Ewen Callaway, Nature News)

Science Funding

Ebola Funding Surge Hides Falling Investment in Other Neglected Diseases

Funding totals from 2015 reveal a trending decrease in funding for neglected diseases, excluding Ebola and other viral hemorrhagic fevers. Neglected diseases are diseases that primarily affect developing companies, thus providing little incentive for private research and development by commercial entities; the other diseases include malaria, tuberculosis, and HIV/AIDS. Given the recent surge of funding for Ebola research, the analysis firm, Policy Cures Research, decided to separate it from the other neglected diseases in its analysis to observe funding patterns independent from the epidemic that dominated the news and international concerns. Funding was tracked from private, public, and philanthropic sources.

The funding for Ebola research has primarily gone to development of a vaccine, and over a third of the funds were provided by industry. For the other diseases, the decline in overall funding is mostly represented by a decline in funding from public entities, primarily comprised of the governments of large, developed countries. Those countries accounted for 97% of the research funding for neglected diseases in 2015, so any significant change in that funding category would affect the overall funding amounts. However, there was also a slight decline in philanthropic funding. When including Ebola with the others, funding of neglected diseases was actually at its highest in the past ten years. It is not known whether money was funneled from the other diseases to Ebola research, or if this decline is indicative of less research spending in general. (Erin Ross, Nature News)

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February 21, 2017 at 10:03 am

Science Policy Around the Web – February 17, 2017

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By: Thaddeus Davenport, PhD

Source: pixabay

CRISPR

Decision in the CRISPR-Cas9 Patent Dispute

This week, Heidi Wedford from Nature News reported that the United States Patent and Trademark Office (USPTO) made a decision on the disputed patents for the gene editing technology known as CRISPR-Cas9 in favor of the Broad Institute of MIT and Harvard. The CRISPR-Cas9 system has been widely publicized, and this publicity is arguably not out of proportion with the potential of this technology to simplify and accelerate the manipulation of DNA of both microbial (prokaryotic) and higher order (eukaryotic) cells for research and therapy. A simplified, programmable version of CRISPR-Cas9 for use in gene editing was initially described by Charpentier and Doudna, and it was rapidly translated for use in eukaryotic cells by Zhang and colleagues at the Broad Institute in parallel with Doudna, Charpentier, and others.

The USPTO decision follows a dramatic and ongoing dispute over whether the patent application submitted by the University of California on behalf of Doudna and Charpentier – which was submitted before that of the Broad Institute, and described the technology in broad terms as a method of cutting desired DNA sequences – was sufficient to protect the CRISPR-Cas9 intellectual property when the Broad Institute later filed a fast-tracked patent application describing the use of CRISPR-Cas9 for use in eukaryotic cells. Because the Broad Institute’s application was expedited, it was approved before the University of California’s application. In January of 2016, the University of California filed for an ‘interference’ proceeding, with the goal of demonstrating to the USPTO that Doudna and colleagues were the first to invent CRISPR-Cas9, and that the patent application from the Broad Institute was an ‘ordinary’ extension of the technology described in the University of California application.

On February 15th of this year, the USPTO ruled that the technology described in the Broad Institute’s application was distinct from that of the University of California’s. The importance of this decision is that the patents granted to the Broad Institute for the use of CRISPR-Cas9 in mammalian cells will be upheld for now. It also creates some complexity for companies seeking to license CRISPR-Cas9 technology. Because of the overlapping content of the CRISPR-Cas9 patents held by the University of California and the Broad Institute, it is possible that companies may need to license the technology from both institutions. The University of California may still appeal the USPTO’s decision, but this is a significant victory for the Broad Institute for the time being. For many scientists, this dispute is a dramatic introduction to the inner workings of the patent application process. We would do well to familiarize ourselves with this system and ensure that it works effectively to accurately reward the discoveries of our fellow scientists and to facilitate the transfer of technology to those who need it most, without imposing undue economic burden on companies and consumers. (Heidi Wedford, Nature News)

Scientific Publishing

Open Access to Gates Foundation Funded Research

Also this week, Dalmeet Singh Chawla reported for ScienceInsider that the Bill and Melinda Gates Foundation had reached an agreement with the American Association for the Advancement of Science (AAAS) that will allow researchers funded by the Gates Foundation to publish their research in the AAAS journals Science, Science Translational Medicine, Science Signaling, Science Immunology, and Science Robotics. This agreement follows an announcement in January in which the Gates Foundation decided that research funded by the foundation would no longer be allowed to be published in subscription journals including Nature, Science, and New England Journal of Medicine, among others, because these journals do not meet the open access requirements stipulated by the new Gates open-access policies. The new Gates Foundation policy requires its grant recipients to publish in free, open-access journals and to make data freely available immediately after publication for both commercial and non-commercial uses. A similar policy is being considered by the nascent Chan Zuckerberg Initiative.

In the agreement with AAAS, the Gates Foundation will pay the association $100,000 in order to make Gates-funded published content immediately freely available online. Convincing a journal as prominent as Science to make some of its content open-access is a step in the right direction, but it is perhaps more important as a symbol of a changing attitude toward publishing companies. Michael Eisen, co-founder of the Public Library of Science (PLoS) open-access journals, was interviewed for the ScienceInsider article and noted, “[t]he future is with immediate publication and post-publication peer review, and the sooner we get there the better.” This sentiment seems to be increasingly shared by researchers frustrated with the hegemony of the top-tier journals, their power over researchers’ careers, and the constraints that subscription-based journals impose on the spread of new information. Funding agencies including the Gates Foundation, Howard Hughes Medical Institute, and the National Institutes of Health are in a unique position to be able to dictate where the research they fund may be published. A collective decision by these agencies to push the publishing market towards an improved distribution of knowledge – through open-access publishing and post-publication peer review – and away from the historical and totally imagined importance of validation through high-tier journal publication would enrich the scientific ecosystem and accelerate innovation. In this regard, the efforts by the Gates Foundation are laudable and should be extended further. (Dalmeet Singh Chawla, ScienceInsider)

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February 17, 2017 at 12:44 pm

Science Policy Around the Web – February 10, 2017

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By: Saurav Seshadri, PhD

Source: pixabay

Sleep

The Purpose of Sleep? To Forget, Scientists Say

Humans spend approximately one third of their lifetime sleeping, yet the purpose of sleep is still largely unknown. A pair of recent studies in the journal Science suggest that a key function of sleep is to give the brain a chance to rewire itself, specifically by cutting down connections between neurons, which naturally scale up during wakefulness, and especially during learning.

In one paper, researchers used 3D electron microscopy to measure the sizes of these connections, called synapses, in mouse brain slices. They found that sleep produced a significant decrease in the size of synapses. Interestingly, this effect was more pronounced in smaller synapses, which were likely strengthened by general information processing while awake, than large ones (~20% of synapses), which may encode more well-established memories. In the other, researchers used two-photon imaging in live mice to observe sleep-induced changes in synapses. They found a similar decrease in synaptic strength, and went on to identify the signaling pathway that caused this effect; blocking this pathway prevented a normal reduction in the scope and magnitude of a learned behavioral response.

These findings underscore the importance of sleep, especially for memory consolidation involved with learning. Studies like these can have far-reaching effects on the public’s perception of sleep, influencing individual habits as well as policy related to education. For example, they suggest that prioritizing sleep when setting school start times (an issue currently under debate in Montgomery County schools) could improve students’ lesson retention and ultimately their test performance. They also point to important cellular and molecular processes that take place during sleep, which could help explain how existing sleep aids adversely affect brain functioning and memory (a public health concern), and ultimately lead to the development of better drugs. (Carl Zimmer, The New York Times)

Drug Policy

Massive Price Hike for Lifesaving Opioid Overdose Antidote

Increased public exposure to the epidemic of opioid abuse, which continues to intensify in the US, has made it increasingly influential in politics, possibly including the recent presidential election.  A crucial tool for communities at the forefront of this public health crisis is naloxone, which can reverse potentially fatal symptoms associated with overdose. The Evzio naloxone auto-injector, produced by Kaleo, is one of two such products approved by the FDA. Kaleo has recently come under fire for increasing the price of Evzio from $690 to $4,500.

Kaleo cites several justifications for the price hike. Firstly, they offer coupons to patients whose insurance doesn’t cover Evzio. Second, they argue that large insurance companies and government agencies (such as the Veterans Health Administration, which sees a high rate of opioid use) can negotiate prices, while other organizations are currently well funded (thanks to public concern) to absorb the increase. Thirdly, they are expanding their donation supply to allow smaller groups to apply for free devices. However, experts say that the increase is not justified by production costs, and some organizations have been forced to switch to alternative drugs.

News of the decision arrives at a time when the public is particularly sensitive to drug pricing, and have made their concern clear to lawmakers. Negotiation with drug companies over prices has been a prominent campaign issue in recent elections. Public outcry following similar moves by investor Martin Shkreli and Mylan led to hearings by a special congressional committee. Soon after the last election, a bill that would have allowed patients to import cheaper drugs from Canada became a high-profile occasion for posturing in the Senate, where it failed despite overwhelming public support. These stories highlight the often antagonistic relationships between the American public, its government, and the pharmaceutical industry, and illustrate how disruptive drug pricing can directly affect policy. (Shefali Luthra, Scientific American)

Scientists in Politics

Geneticist Launches Bid for US Senate; while Empiricists Around the Country Will March for Science

Donald Trump’s agenda of self-serving lies and denial of evidence has led to unprecedented levels of engagement and activism across the country. The scientific community has been especially impacted by Trump’s brand of broad, allegedly populist anti-intellectualism. Thus, although the empirical facts uncovered by scientific research are inherently apolitical and should be treated as such, scientists are beginning to mobilize to oppose the Trump administration in several ways.

One essential path to policy change is increased representation. With that in mind, evolutionary biologist Dr. Michael Eisen, an HHMI-funded investigator at UC Berkeley and co-founder of the People’s Library of Science (PLOS), recently announced his candidacy for the US Senate in 2018. Dr. Eisen’s platform seems to center on bringing a scientific perspective to Senate proceedings, and working towards comprehensive yet practical solutions to issues such as climate change. More of Dr. Eisen’s views can be found on his twitter feed and blog.

Protests are another way for individuals to make their voices heard by policy makers. The March for Science, which currently has over 350,000 followers on Facebook, will be an opportunity for ‘scientists and science enthusiasts’ to both call for and demonstrate support for the scientific community, and promote solidarity between science and the public. The main march will be held on April 22nd, 2017 in Washington D.C.; satellite marches are scheduled in over 100 additional cities. Organizers hope to maintain the momentum gained by January’s Women’s Marches, which saw historic attendance. (Sara Reardon, Nature News; Lindizi Wessel, ScienceInsider)

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Science Policy Around the Web – February 3, 2017

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By: Eric Cheng, PhD

Source: pixabay

Trump and Science

Scientists’ Lives Upended by Trump’s Immigration Order

New executive orders have been signed by President Trumpthat suspend immigration into the United States from “terror-prone regions.” The target countries listed are Iran, Iraq, Libya, Somalia, Syria, Sudan, and Yemen. These new immigration orders have caused chaos at U.S. airports to people from these countries, including people with a valid U.S. visa or green card who were traveling outside of the U.S. when the order was signed. It is also affecting scientists who are currently in the United States, but are visiting from the affected countries. For example:

Ehssan Nazockdast was planning to attend his sister’s wedding in Tehran in March. One hitch: The specialist on fluid dynamics at New York University in New York City is an Iranian citizen. That leaves him vulnerable under an executive order signed by U.S. President Donald Trump on Friday that calls for the rigorous vetting of applicants for U.S. visas from Iran and six other predominantly Muslim nations, and bars the entry of any citizen from those nations for 90 days while procedures for that vetting are put in place. Nazockdast has lived in the United States for nearly a decade, has a green card, and has two young daughters with a wife who is a U.S. citizen. But now that Nazockdast is branded with a scarlet letter, he dare not leave. “I’m living in a big prison called the United States of America,” he says.

A federal judge has issued an emergency stay that halts deportations of refugees with valid U.S. entry documents. Two days after executive order was signed, John Kelly, Secretary for Homeland Security, issued a statement deeming “the entry of lawful permanent residents to be in the national interest,” which was interpreted as allowing the re-entry of green card holders. from nations covered by the order, although they could receive extra scrutiny. The Council on American-Islamic Relations still intends to file a lawsuit in the U.S. District Court Western District of Virginia challenging the constitutionality of what it calls the “Muslim ban.”

Over 7000 scientists of all nationalities and religions, including 43 Nobel laureates, have signed an open letter, warning that Trump’s order “significantly damages American leadership in higher education and research” and calls it “inhumane, ineffective, and un-American.” (Richard Stone and Meredith Wadman, ScienceInsider)

Science Policy

Scientists ‘Partly to Blame’ for Skepticism of Evidence in Policymaking, says AAAS CEO

In addition to access to high-quality technical experts to handle science-related global crisis, an United States president also needs to believe that scientific evidence is useful in setting government policy says American Association for the Advancement of Science (AAAS) CEO Rush Holt. At the winter meeting of the American Physical Society in Washington, D.C., Dr. Holt remarked how scientists are partly to blame for the decreased priority of scientific evidence in U.S. policymaking.  One potential explanation for this devaluation of evidence may be due to scientists’ way of presenting evidence that is too “condescending and hierarchical. We might say, ‘Let me try to explain this to you. Maybe even you can understand this.’ And that is not very effective. So we are partly to blame,” stated Dr. Holt.

Dr. Holt believes that “reverence for evidence” has been part of the nation’s political discussion since the United States was founded, and traditionally covers both parties. The biggest challenge now will be to try and empower policymakers to think about any scientific evidence presented to them and to evaluate the validity of the conclusion based on the evidence for themselves. (Jeffery Mervis, ScienceInsider)

Public Health

Senate Finance Committee OKs Tom Price, MD, for HHS Chief

The Senate Finance Committee voted 14-0 to approve the nomination of Rep. Tom Price, MD, (R-Ga), to head the Department of Health and Human Services (HHS). All votes were from the Republican members of the committee because 12 Democratic members boycotted the executive session to confirm Dr. Price. Although the committee normally requires at least one member from each party present to reach its quorum requirement, the rule was suspended prior to the vote. Now Dr. Price’s nomination will go before the Senate for a vote, which will only need a simple majority of 51 votes for confirmation. (Robert Lowes, Medscape)

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February 3, 2017 at 10:01 am

Science Policy Around the Web – January 27, 2017

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By: Nivedita Sengupta, PhD

Source: NIH Image Gallery on Flickr, under Creative Commons

Human Research Regulation

US Agency Releases Finalized ‘Common Rule’, Which Govern Human-Subjects Research

On September 8, 2015 the US Department of Health and Human Services (HHS) proposed significant revisions to the Federal Policy for the Protection of Human Subjects which is also known as the “Common Rule”. “Common Rule” is the set of federal regulations governing the conduct of clinical research involving human subjects. Among the proposed changes, an important one was regarding getting peoples’ consent before using the biological samples for subsequent studies. On 18th January 2017, the final version of the rule was released in which the proposed change was abandoned. This is a blow to the patient-privacy advocates, however the US National Academies of Sciences, Engineering and Medicine argued against that requirement and others citing that the changes would impose an undue burden on researchers and recommended that it be withdrawn.

The current version of Common Rule has generated mixed feelings among people. Researchers are happy that the government listened to scientists’ fears about increased research burdens whereas people like Twila Brase, president and co-founder of Citizens’ Council for Health Freedom in St Paul, Minnesota, are disappointed as they believe that these specific changes are ought to be made. Moreover the new version of the Common Rule requires that scientists include a description of the study, along with the risks and benefits, on the consent forms used by patients, and federally-funded trials should post patient consent forms online. However, these requirements do not extend to trials that are conducted with non-federal funds. (Sara Reardon, Nature News)

Biomedical Research

An Open-Science Effort to Replicate Dozens of Cancer-Biology Studies is Off to a Confusing Start

The Reproducibility Project on Cancer Biology was launched in 2013 to scrutinize the findings of 50 cancer papers from high-impact journals. The aim is to determine the fraction of influential cancer biology studies that are sound. In 2012, researchers at the biotechnology firm Amgen performed a similar study and announced that they had failed to replicate 47 of 53 landmark cancer papers but they did not identify the studies involved. In contrast, the reproducibility project makes all its findings open. Full results should appear by the end of the year and eLife is already publishing five fully analyzed reports in January. Out of the five, one failed to replicate and the remaining four showed replication results that are less clear.

These five results paint a muddy picture for people waiting for the outcome to determine the extent of impact of these studies. Though some researchers praised the project, others feared unfair discredit of their work and career. According to Sean Morrison, a senior editor at eLife, the reason for the “uninterpretable” results is “Things went wrong with tests to measure the growth of tumors in the replication attempts and the replication researchers were not allowed to deviate from the protocols, which was agreed at the start of the projects in consultation with the original authors”. “Doing anything else — such as changing the experimental conditions or restarting the work — would have introduced bias”, says Errington, the manager of the reproducibility project.

According to Errington, the clearest finding from this project is that the papers include very few details about their methods. The replication researchers had to spend hours to work out the detailed protocols and reagents along with the original authors. Even after following the exact protocols, the final reports include many reasons why the replication studies might have turned out differently, including variations in laboratory temperatures to tiny variations in how a drug was delivered. He thinks that the project helps to bring out such confusing details to the surface, and it will be a great service for future follow up work to develop a cure for cancer. However, scientists think that such conflicts mean that the replication efforts are not very informative and couldn’t be compared to the original and will only cause delays in advancing future clinical trials. (Monya Baker and Elie Dolgin, Nature News)

 

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Science Policy Around the Web – January 24, 2017

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By: Leopold Kong, PhD

Landfill by Dhscommtech at GFDL, via Wikimedia Commons

Environment

New Discovery Could Lead to a Safer Solution to Plastic Pollution

Polyethylene terephthalate (PET) is a commonly used resin of the polyester family used in the fibers for clothing and liquid containers. In 2015 alone, 56 million tons of PET was produced. Although recyclable, with 1.5 billion pounds recovered annually in the United States, PET is not biodegradable and is a major presence in landfills. Screening 250 samples of contaminated soil, waste water and sludge from a bottle recycling factory for microorganisms that can grow on PET, a team of Japanese scientists has discovered a bacterium, Idoenella sakaiensis, that can break down this tough plastic. Recently spotlighted as a major breakthrough of 2016 by the American Chemical Society, research on the bacterium continues as scientists seek to unlock the mechanism behind the biodegradation pathway that was previously thought to be impossible. Professor Kenji Miyamoto, one of the study authors, said, “This is the first PET-degrading bacterium found [with potential] to develop a new and nature-friendly system”. (Research Highlights, Keio University).

Biomedical Research

Trump Asks NIH Director Francis Collins to Stay On

Last Thursday, on the eve of the inauguration, the National Institutes of Health (NIH) announced that Dr. Francis Collins has been asked to continue his role as NIH director by the Trump administration for an unspecified time. This eleventh hour development came as Collins received back the letter of resignation he had sent late last year, something all presidential appointees do. If asked to stay on through this presidential term, Collins, part of Obama’s science ‘dream team’, would be the first NIH director since the 1970s to be chosen by two presidents.

Ezekiel Emanuel, a bioethicist at the University of Pennsylvania said, “In general, I think more than eight years has not been a good idea. There’s a cycle, and eight years is hard to have new ideas and new energy.”  Nonetheless, Collins, a National Academy of Sciences member who led the human genome project and a highly vocal Christian apologist, would serve as an effective bridge between the research community and the new Republican administration to secure much needed funding for basic research. Tony Mazzashi, senior director for policy and research at the Association schools and Programs of Public Health in Washington DC said, “ I think everyone in the research community will be thrilled.” (Jocelyn Kaiser, Science)

Public Health

Novavax Starts New Clinical Trial in Bid to Prove Failed RSV Vaccine

Respiratory Syncytial Virus (RSV) is a significant public health burden, infecting almost all children by age 2, with 5 to 20 out of 1,000 requiring hospitalization and with a mortality rate of 8 to 34 out of 10,000. Unfortunately, the development of an effective vaccine has been challenging. In the late 1960s, an RSV vaccine for infants devastatingly failed clinical trials with 80% of children receiving the shot being hospitalized. Recent advances in immunology and the RSV vaccine target has led to a new generation of potentially safer and more effective vaccine candidates from industry giants Novavax, GlaxoSmithKline, Global Vaccines, AstraZeneca and MedImmune. Also being explored is vaccination of expectant mothers to protect infants.

However, the field took a hit last year when Novavax’s candidate vaccine failed its phase 3 clinical trials, resulting in a 30% layoff of its workforce. Nonetheless, last Thursday, the company announced that it has started a new phase 2 trial on older adults in the southern hemisphere.  “We expect the results from this trial to inform the next steps in our older adults program and would ensure we maintain our leadership position in this very attractive market opportunity,” said Stanley Erck, president and CEO of Novavax. (Tina Reed, Washington Business Journal)

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January 24, 2017 at 10:04 am