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Americans Are Happier in States That Spend More on Libraries, Parks and Highways

Such ‘public goods’ also are less likely to spark political conflict, Baylor researcher says Americans are happier in states where governments spend more on public goods, such as libraries, parks, highways, natural resources and police protection, a Baylor University study has found. “Public goods are things you can’t exclude people from using — and one person using them doesn’t stop another from doing so,” said researcher Patrick Flavin, Ph.D., associate professor of political science in Baylor’s College of Arts & Sciences. “They’re typically not profitable to produce in the private market, so if the government doesn’t provide them, they will either be under-provided or not at all.” Public goods spending makes communities “more livable, with more amenities,” Flavin said. “If roads are completed and kept up, so that people aren’t stuck in traffic, they have more time to do things they enjoy doing. Large parks are social spaces — and one clear finding of happiness studies is that people who are more socially connected tend to be happier.” Another benefit of spending money on public goods is that such amenities generally boost home values — and “while higher property taxes generally accompany higher home values, it seems that the good outweighs the unfortunate part about having to pay higher taxes,” Flavin said. In his study, published in the journal Social Science Research, Flavin analyzed data on respondents’ self-reported levels of happiness for 1976-2006 from the General Social Survey, a representative sample of Americans that monitors social characteristics and attitudes of Americans and is a project of the independent research organization NORC at the University of Chicago. Flavin also analyzed detailed government spending data for states from the U.S. Census Bureau for 1976-2006. Revenues to fund state public goods are raised from a combination of state taxes and transfers from the federal government to states, averaging 22.5 percent of total state revenues for that 30-year period. “We can look at the city where people live, their neighborhoods, and see how public goods spending predicts happiness after taking other important factors, such as marital status, health, education and income, into account,” Flavin said. He also found that public goods spending has broad benefits across income, education, gender and race/ethnicity lines. “Compared to a lot of the other government spending, public goods tend to be less controversial between liberals and conservatives, Democrats and Republicans, compared to poverty assistance or unemployment benefits, where there is definite disagreement between political parties,” Flavin said. “I think there is less political conflict over public goods spending simply because if they government doesn’t provide them, they won’t be provided at all.” Flavin cautioned that there is not necessarily a cause-and-effect relationship between public goods and happiness. “It could be that happier citizens self-select by moving to states that spend comparatively more on public goods,” he said. “It also is possible that happier citizens support higher spending on public goods and elect state officials to deliver on that policy.” Because some spending for public goods comes from local government, Flavin hopes to do a study linking citizens to their local city instead of only to the state. And because living a happy and satisfying life is a nearly universal human goal, he predicts that better understanding of how policies concretely impact quality of life will receive increasing attention from researchers in the years to come. ABOUT BAYLOR UNIVERSITY Baylor University is a private Christian University and a nationally ranked research institution. The University provides a vibrant campus community for more than 17,000 students by blending interdisciplinary research with an international reputation for educational excellence and a faculty commitment to teaching and scholarship. Chartered in 1845 by the Republic of Texas through the efforts of Baptist pioneers, Baylor is the oldest continually operating University in Texas. Located in Waco, Baylor welcomes students from all 50 states and more than 80 countries to study a broad range of degrees among its 12 nationally recognized academic divisions. ABOUT BAYLOR COLLEGE OF ARTS & SCIENCES The College of Arts & Sciences is Baylor University’s oldest and largest academic division, consisting of 25 academic departments and seven academic centers and institutes. The more than 5,000 courses taught in the College span topics from art and theatre to religion, philosophy, sociology and the natural sciences. Faculty conduct research around the world, and research on the undergraduate and graduate level is prevalent throughout all disciplines.

Why voters prefer moderate leaders in the face of terrorism

From 1970 to 2016, 11,176 people in Europe died from terrorist attacks. These numbers do not include those that were wounded or missing. Terrorist attacks, especially deadly ones, are likely to affect the way people vote. But what is the exact impact of terrorism on voting patterns? Following terrorist attacks, in international elections people are more likely to vote for moderate or centrist political parties as opposed to right and leftist parties, according to a study published by Augusta University researchers Dr. Lance Hunter and Dr. Martha Ginn. The study, published in “Global Policy” on Jan. 3, 2019, analyzed the effect terrorist attacks had on voting patterns for left, right and moderate political parties in elections for more than 50 democracies worldwide. The findings have several implications for public policy. First, it is clear that terrorism affects the political behavior of voters. Therefore, Hunter and Ginn recommend that governments develop and communicate sensible counterterrorism policies in effort to maintain electoral stability. Second, counterterrorism policies that are viewed as overly aggressive in nature or passive are likely to be met with skepticism by voters. This is one possible reason why more moderate and centrist parties experience an increase in votes following terrorist attacks. The party in power loses electoral support during increased terrorist activity. A possible solution to this, Hunter and Ginn said, includes developing sensible, realistic counterterrorism policies that address security concerns while avoiding reactionary policies. Finally, rightist parties suffered the most electorally and lost support following both international and domestic attacks while leftist parties lost support following domestic attacks. Hunter and Ginn suggest that parties should tailor their counterterrorism proposals and messaging depending on the type of attack.

All in all, it's just another brick in the wall. Did rhetoric trump the importance of a national address?

It seemed all of America tuned in Tuesday evening at 9 PM Eastern to hear just what President Donald Trump had to say as he spoke to a nation caught in the middle of a government shutdown. With federal services all but stagnant across the country, and those employees considered essential forced to work without pay, most expected a pitch to a nation that included a solution and ideally a moderated and mature speech. After all, there is a lot at stake for every American who is either employed by, engaged with or in need of the federal government. However, that was not the case.  What did come was a short speech that was long on rhetoric, blame and ultimatums instead of resolution.   In the past, when addressing the nation, a President would do so to share information of national importance, like Obama’s speech about the killing of Osama Bin Laden or Ronald Reagan speaking to America about the Iran-Contra Hearings. These were big deals with a significant message. Speaking with Canada’s national broadcaster, University of Mary Washington’s Stephen Farnsworth had this observation to share. “By taking such partisan swipes from the grandeur of the Oval Office during a prime-time address, Trump runs the risk of "overexposure," or of being accused of cheapening a time-honoured tradition, said Stephen Farnsworth, a political science professor with the University of Mary Washington who specializes in presidential communications. It's not clear whether the president's speech will have any impact on the border security stalemate. But Trump's speech may even have implications for future Oval Office broadcasts, Farnsworth said.” So, what was gained by the address? Did President Trump essentially ‘cry-wolf’ and cheapen the significance of a national address? Or did it serve his purpose and support his base? And, did the Democrats blow an opportunity to effectively respond? There will be a lot of analysis of Tuesday’s TV-time and that’s where the experts from the University of Mary Washington can help. Dr. Stephen Farnsworth is professor of political science and international affairs at the University of Mary Washington. A published author and a media ‘go-to’ on U.S. politics, he is available to speak with media regarding this issue. Simply click on his icon to arrange an interview.

Big trouble in Little Taiwan? Our experts weigh in.

It won’t be just America that faces a heated and high-stakes election in 2020, the small country of Taiwan is also at political cross-roads and its future could hang in the balance. To look back, just over two years ago, the pro-independence Democratic Progressive Party (DPP) won a major victory in both the presidential and the legislative elections over the Nationalist Party or Kuomintang (KMT) in Taiwan. KMT’s pro-China approach was thoroughly rejected by voters. However, recent elections saw a serious shift back in opinions toward the KMT’s favor, delivering a severe blow to Taiwanese President Tsai Ing-wen. In a recent Financial Times piece, added her perspective. “Elizabeth Freund Larus, a Taiwan expert at the University of Mary Washington in Virginia, said China would probably seek to capitalize on a series of DPP losses in local elections in November to sow discontent among Taiwanese and boost support for the China-friendly opposition party, the Kuomintang, ahead of the 2020 presidential election. “China’s leaders are like sharks in the water: they smell blood,” she said.” Taiwan seeks to bolster international support after China threats (Financial Times) So, what lies ahead for Taiwan? Will China meddle or push for KMT support? Can it be stopped? Will there be international support against Chinese interference? How will China react? And is this a political hot potato that could play into the upcoming US primaries and elections? There’s a lot out there that just not known, and that’s where our experts can help. Elizabeth Larus is a professor of political science at the University of Mary Washington and is an #expert on China and the field of Asian studies.  She is available to speak to media regarding this topic – simply click on her icon to arrange an interview.

Declaring a New Year's Resolution for 2019? Baylor Experts Can Help

WACO, Texas (Dec. 17, 2018) – As 2019 approaches, many Americans are considering ways to improve themselves via New Year’s resolutions. Whether it’s personal, like losing weight or clearing clutter, or it’s professional, such as being a better manager or breaking away from smartphones, the options are wide-ranging. Here is a listing of Baylor University research that might help advise those seeking positive change in the coming year. First and Foremost, Resolve not to Over-resolve Only 10 to 20 percent of people keep their resolutions, says Sara Dolan, Ph.D., associate professor and graduate program director of clinical psychology. She advises setting “bite-sized goals instead of a massive behavior change.” Rather than giving up sugar completely or going all out at the gym, she advises achieving small successes before moving on. Ask Yourself: “Do I really want to work from home?” Many U.S. employees believe working from home – or at least away from the office – can bring freedom and stress-free job satisfaction. A 2018 Baylor University study says, “Not so fast.” The research, led by Sara Perry, Ph.D., assistant professor of management in Baylor University’s Hankamer School of Business, found that: Autonomy is critical to protecting remote employees’ well-being and helping them avoid strain. Employees reporting high levels of autonomy and emotional stability appear to be the most able to thrive in remote-work positions. Employees reporting high levels of job autonomy with lower levels of emotional stability appear to be more susceptible to strain. “Any organization, regardless of the extent to which people work remotely, needs to consider well-being of their employees as they implement more flexible working practices,” the researchers wrote. Read more here. Save Money by being a Better Negotiator In today’s retail climate, where stores struggle to keep up with online competition and customers can compare prices with the ease of their smartphones, the price tag is just a starting point for negotiations, said negotiation expert Emily Hunter, Ph.D., associate professor of management in Baylor’s Hankamer School of Business. “No longer do you need to pay sticker price for everything you buy. The customer is now empowered to have a say in pricing, and even hourly retail workers are often empowered to give price discounts when requested,” Hunter said. Hunter said negotiations – whether in a retail setting or in the workplace – require confidence. “Many people are hesitant to negotiate because they don’t know how or they are worried about the other person’s reaction (Will they think I’m greedy?),” she said. “But practice can increase your confidence in your ability to negotiate. Rejection is less common than you fear, and retail stores especially are often willing to work with you.” She offered the following tips to increase the chances of greater deals at the check-out counter. Resolving to Be More Generous in the New Year Many Americans already have enough “stuff,” and the gift-giving season sometimes adds to that collection of things we really don’t need. Instead of always receiving, how can we resolve to be more generous in the New Year? “Whatever our station, however much money or resources we have, we all have something to share and something to give,” says Andy Hogue, Ph.D., senior lecturer in Baylor’s Honors College who teaches a course on philanthropy and the public good. “I like the idea of thinking in terms of a New Year’s resolution, sort of resolving to be more generous and helping people to think in those ways.” Hogue offers individuals and families four ways to develop a spirit of generosity in the New Year. Home Cooking Saves Money, Encourages Better Diet The more home-prepared foods used, the less risk there is of eating too many calories and fat calories, says Baylor University nutrition expert Janelle Walter, Ph.D., professor of family and consumer sciences and Nutrition Sciences Program coordinator. Home cooking also saves money and allows for more fruits, vegetables and dairy products — which often are missing when pre-prepared products are used — as well as less fat, sugar and salt. Some tips for prepping at home are making a precise list, lining up recipes and lists of ingredients, shopping when you aren’t hungry and preparing five main dishes at a time to see you through a few days. Involve your family in choosing foods, shopping and preparing foods, Walter says. Many simple and quick recipes are on online sites, she said, referencing these from Southern Living. Consider a New Approach to Dieting Meredith David, Ph.D., assistant professor of marketing in Baylor’s Hankamer School of Business, researched successful dieters and how they were different from others. Her research results have received national attention. “Our research shows that instead of creating rules to avoid one’s favorite treats, dieters should focus on eating healthy foods that they enjoy,” David said. “Dieters who restrict themselves from consuming the foods they love most may be setting themselves up for failure. Instead, they may be better off by allowing occasional ‘treats’ and focusing attention on healthy foods that they enjoy and making it a point to include those tasty but healthy foods in their diet.” Read the full article. Be Humble and Helpful In hard times, you know how much a helping hand means — and how humbling those times can be. So it might be good to resolve to look for opportunities to assist in 2019, while remembering not to pat yourself on the back for doing so. A decision to help someone else is influenced by time pressure, number of bystanders, empathy or a person's own distress — but that’s not all, says Baylor researcher Wade Rowatt, Ph.D., professor of psychology and neuroscience. “While several factors influence whether people will volunteer to help, it appears that humble people, on average, are more helpful than individuals who are egotistical or conceited.” Cultivate Patience — and Better Mental Health People who are more patient toward others also tend to be more hopeful, grateful and satisfied with life, says Sara Schnitker, Ph.D., associate professor of psychology and neuroscience. And there is more than one type of patience, including interpersonal patience — dealing with annoying people without losing your cool; handling life hardships — such as illness or unemployment — without frustration or despair; and coping with such daily hassles as traffic jams, computer woes and long lines. In her research, Schnitker invited undergraduates to two weeks of patience training, where they learned to identify feelings and their triggers, regulate their emotions, empathize and meditate. If you want to build your own patience, she recommends following three steps: identify, imagine and sync. First, take a moment to slow down an identify how you are feeling and why you might be feeling that way. Second, try to imagine or reappraise the situation from a different perspective or in a new way that helps you to be calm. Finally, sync with your purpose. Try to connect how what you are doing or enduring helps you pursue larger goals or your life purpose. When Ailing, Talk to A Doctor Instead of Searching the Internet for Answers Rather than heading to the doctor — or even the medicine cabinet — some people turn first to the Internet when they are ailing , according to a Baylor University researcher. Especially for folks who have trouble handling uncertainty, "cyberchondria" — the online counterpart to hypochondria — worsens as they seek answers, says Thomas Fergus, Ph.D., an associate professor of psychology and neuroscience in Baylor's College of Arts & Sciences. “They may become more anxious. And the more they search, the more they consider the possibilities,” he says. Doubts about health also can trigger worries about medical bills, disability and job loss, he said. And that can lead to a Catch-22 of more Googling (sometimes of questionable sources). Rather than giving in to cyberchondria, resolve to call your doctor — and take what you read with a grain of salt. In Conflicts with your Significant Other, Relinquish Power During spats with your spouse or significant other, the most common thing people want is not an apology, but a willingness to relinquish power, says Keith Sanford, Ph.D., professor of psychology and neuroscience in Baylor University's College of Arts & Sciences. That comes in many forms, among them giving a partner more independence, admitting faults, showing respect and being willing to compromise. Following closely behind the desire for shared control was the wish for the partner to show more of an investment in the relationship by such ways as sharing intimate thoughts or feelings, listening and sharing chores and activities, Sanford said. Sleep Better in the New Year Writing a “to-do” list at bedtime may aid in falling asleep, according to a Baylor University study by Michael K. Scullin, Ph.D., director of Baylor’s Sleep Neuroscience and Cognition Laboratory and assistant professor of psychology and neuroscience. Scullin's 2018 research compared sleep patterns of participants who took five minutes to write down upcoming duties versus participants who chronicled completed activities. Scullin suggests that writing a list may allow the brain to “offload” them instead of cycling through them repeatedly. Other hints: Use the bed for sleep rather than studying or entertainment; keep a regular sleep schedule; avoid electronics near bedtime; don’t take long day naps; and stay away from stimulants at least six hours before bedtime. Clear Out Clutter Without Getting Frazzled “Don’t try to organize the entire house in one weekend,” said Elise King, assistant professor in the department of family and consumer sciences. “You are much more likely to complete a task, especially one that you’ve probably been avoiding, if you break it into small goals. Don’t try to clean out an entire room over a weekend; instead, focus on the desk one week, the closet the next, and so forth.” Finally, involve your family, strive to make organization a routine — and reward yourself for your efforts. Break Away from the Smartphone Baylor marketing researchers James Roberts and Meredith David, Ph.D. have conducted numerous studies on the effects of smartphone technology on relationships. Their studies on “phubbing” – phone snubbing – have garnered national and international interest, given the pervasiveness of smartphone technology and its impact on relationships. Their studies have found: Bosses Who “Phone Snub” Their Employees Risk Losing Trust and Engagement “Phubbing” can damage romantic relationships and lead to higher levels of depression People who are phone snubbed by others are, themselves, often turning to their smartphones and social media to find acceptance “Although the stated purpose of technology like smartphones is to help us connect with others, in this particular instance, it does not,” David said. “Ironically, the very technology that was designed to bring humans closer together has isolated us from these very same people.”

Better Sleep - Not 'All-Nighters' - Helps Students on Final Exams

Students given extra points if they met “The 8-hour Challenge” — averaging eight hours of sleep for five nights during final exams week — did better than those who snubbed (or flubbed) the incentive, according to Baylor University research. “Better sleep helped rather than harmed final exam performance, which is contrary to most college students’ perceptions that they have to sacrifice either studying or sleeping. And you don’t have to be an ‘A’ student or have detailed education on sleep for this to work,” said Michael Scullin, Ph.D., , director of Baylor’s Sleep Neuroscience and Cognition Laboratory and assistant professor of psychology and neuroscience in Baylor’s College of Arts & Sciences. While students who successfully met the sleep challenge received extra points for the “mini-incentive,” the additional credit was not included in the analysis of how well they performed on the finals, emphasized Elise King, assistant professor of interior design in Baylor’s Robbins College of Health and Human Sciences. “They didn’t just perform well because they received extra points,” she said. “Students know that sacrificing sleep to complete school work is not a healthy choice, but they assume they don't have a choice, often remarking that there aren't enough hours in the day for coursework, extracurriculars, jobs, etc. “This removes that excuse.” Research participants included undergraduate interior design students and students in upper-level psychology and neuroscience classes. While the psychology classes emphasized education about sleep, the interior design students did not receive any formal training in sleep. Those who opted to take the challenge wore wristband sleep-monitoring devices for five days to ensure accurate study results. “The students didn’t need the extra credit to perform better, and they weren’t really better students from the get-go,” Scullin said. “If you statistically correct for whether a student was an A, B, C, or D student before their final exam, sleeping 8 hours was associated with a four-point grade boost — even prior to applying extra credit.” The collaborative interior design study — “The 8-Hour Challenge: Incentivizing Sleep During End-of-Term Assessments” — was published in the Journal of Interior Design. Scullin’s study of psychology students — “The 8-Hour Sleep Challenge During Final Exams Week” — was published in Teaching of Psychology. Poor sleep is common during finals as students cut back on sleep, deal with more stress, use more caffeine and are exposed to more bright light, all of which may disrupt sleep. Fewer than 10 percent of undergraduates maintain the recommended average of 8 hours a night or even the recommended minimum of 7 hours, previous research shows. But with incentives, “we can potentially completely reverse the proportion of students meeting minimum sleep recommendations — 7 hours a night — from fewer than 15 percent up to 90 percent,” Scullin said. “Half of students can even meet optimal sleep recommendations of 8 to 9 hours.” Here are the findings of the two studies: PSYCHOLOGY STUDENTS In the study of psychology students, 34 students in two undergraduate courses could earn extra credit if they averaged 8 hours of sleep during final exams week or at least improved upon their sleep from earlier in the semester. The 24 who opted to take the challenge averaged 8.5 hours of sleep, with 17 meeting the goal. On the final exam, students who slept more than 8 hours nightly performed better than those who opted out or slept less than 7.9 hours. The incentive was 8 points — the equivalent of 1 percent on a student’s overall class grade. “It’s worth noting that one student who had a D-plus grade before the final but slept more than 8 hours a week during finals week, remarked that it was the ‘first time my brain worked while taking an exam,’” Scullin said. INTERIOR DESIGN STUDENTS In the interior design study challenge, students earned credit if they averaged 8 or more hours a night but received no grade change if they averaged 7 to 7.9 hours a night. Of the 27 students enrolled in the program, 22 attempted the challenge. Compared with a group of 22 students who did not try for the extra points, very few (9 percent) averaged 8 hours or even 7 hours (14 percent). The 8‐hour challenge increased the percentage of 8‐ and 7‐hour sleepers to 59 percent and 86 percent respectively. Students who took part in the challenge slept an average of 98 minutes more per night compared to students who were not offered the incentive but were monitored. “Critically, the additional sleep did not come at a cost to project performance,” King said. “Students who showed more consistent sleep performed better than those who had less consistent sleep. And students who achieved the challenge performed as well as or better than those who did not take the challenge." In a study of sleep and creativity done in 2017, King and Scullin found that interior design students with highly variable sleep habits — cycling between “all-nighters” and “catch-up” nights — had decreased cognition in attention and creativity, especially with major projects. Design students customarily complete finals projects rather than final exams. “Whether or not they ‘pull an all-nighter,’ when students cut their sleep, the effects are obvious,” King said. “They have trouble paying attention during class, and they aren't as productive during studio time.” She noted that there is a cultural acceptability — at least in design professions — related to sleep deprivation, in part because of the notion of the "tortured artist" who finds inspiration in the wee hours. “Some fields might find it unprofessional, but for many years, in design, sacrificing sleep was viewed as a rite of passage. That's something we're trying to change,” King said. “Even during stressful deadline weeks, students can maintain healthy sleep habits.” “To be successful at the challenge, students need to manage their time better during the day. Getting more sleep at night then allows them to be more efficient the next day,” Scullin said. “By training students in their first year of college, if not earlier, that they can sleep well during finals week without sacrificing performance, we may help to resolve the ‘global sleep epidemic’ that plagues students in America and abroad.” *Co-researcher on the interior design sleep study was Christine Mobley, Ph.D., lecturer at the University of Kentucky.

Cybersecurity expert offers holiday shopping tips for protecting identity

Amid the many warnings this holiday season about protecting your identity while shopping online comes advice from Scott Shackelford, associate professor of business law and ethics in the Indiana University Kelley School of Businessand one of the nation's leading cybersecurity experts. "In some ways shopping online is getting safer," said Shackelford, also chair of the Kelley School's Cybersecurity Program in Risk Management and director of the Ostrom Workshop Program on Cybersecurity and Internet Governance. "For example, a few years ago it was relatively uncommon for many sites to use encrypted https technology, but that's become the norm. However, as may be seen by a quick scan of the news, data breaches continue. "The good news is that the cost of those breaches is going up with Federal Trade Commission and European Commission investigations ongoing into firms like Equifax and Facebook, and consumer patience is also wearing thin," he added. "One recent survey, for example, found that 20 percent of consumers would not shop again at a firm that experienced a data breach." Shackelford offers practical advice for holiday shoppers. In essence, there's a lot you can do to become harder targets for cyber criminals, including: Consider freezing your credit. You don't need it open unless you open a new credit card or loan, and even then you can unfreeze it for a short window to allow for the credit check. Install antivirus and antispyware software, use auto-update, and always enable multifactor authentication on all of your accounts. When using public Wi-Fi, use browsers like Tor to make it more difficult for hackers to spy on you. Keep all software up to date -- especially Windows, but also programs like Adobe Reader, Flash and Java, which are often convenient backdoors that can be closed through frequent updates. Use strong passwords of at least 14 characters, keep them secret, and change them often. Consider starting with a favorite sentence, and then just take the first letter of each word. Add numbers, punctuation or symbols for complexity. And be sure to change any default passwords on your new smart devices. Never turn off your firewall; it's an important software program that helps stop viruses and worms. Use flash drives cautiously; they are easily infected. In fact, one of the biggest breaches of U.S. military systems to date was due to a flash drive. Encrypt sensitive information on your computer. Be conscious of what you click on, both in emails and on the web. When in doubt, double check before accessing new files. Look for sites with "https" in the URL. Do not use banks or other sensitive websites that do not have the "s."

Overhaul of FDA's approval process for medical devices overdue, but balanced approached needed

The Food and Drug Administration has announced plans to overhaul its system for approving a certain category of medical devices, which critics have said fails to protect consumers from risky implants and medical instruments.   George Ball, assistant professor of operations and decision technologies and the ArcelorMittal Supply Chain Faculty Fellow, at the Indiana University Kelley School of Business, studies the medical device industry, in particular medical device recalls.   There are two primary approval pathways for medical devices. “510(k)” clearances are reserved for products that demonstrate substantial equivalence to a previously approved device. Clinical trials are normally not required and this method is much faster and cheaper than the other pathway, a “Pre-Market Approval (PMA).”   PMA new product submissions are reserved for those products that are new or substantially modified from previously approved devices. Clinical trials in humans and laboratory study data are normally required to demonstrate safety and efficacy. In comparison to 510(k) clearances, PMA approval pathways are time-consuming and expensive.   “The FDA’s announcement regarding an overhaul of the 510(k) approval process seems to be warranted, as medical device product approvals are currently on two ends of an extreme spectrum,” Ball said. “New PMA products can require years and millions of dollars to successfully obtain approval by the FDA. Conversely, 510(k) clearances are significantly faster and cheaper, as the manufacturer has to simply demonstrate equivalence with similar, already approved products.   “As 510(k) products represent the bulk of new product approvals, they also represent the bulk of medical device recalls, unsurprisingly,” Ball said. “In the last decade, 510(k) products were recalled at a ratio of 17-to-1, compared to PMA products.”   “However, the method of approval currently practiced for 510(k) products has many benefits for manufacturers as well,” he said. “Demonstrating equivalence with prior approved similar devices makes the development time exponentially faster compared to PMA product approval times.   “A middle-ground here seems logical and advisable. For example, the FDA approves products using a two-pronged approach: safety and efficacy. While efficacy may be easily established by demonstrating similarity to prior products, evidence of safety for 510(k) products may require additional verifications and tests. Doing so may help ensure that new 510(k) products, which are often much more technologically advanced than the ones they are compared against for approval purposes, are also safe for patients.”   Ball can be reached at 812-856-0625 or gpball@indiana.edu

Chinese scientists are creating CRISPR babies

A daring effort is under way to create the first children whose DNA has been tailored using gene editing. When Chinese researchers first edited the genes of a human embryo in a lab dish in 2015, it sparked global outcry and pleas from scientists not to make a baby using the technology, at least for the present. It was the invention of a powerful gene-editing tool, CRISPR, which is cheap and easy to deploy, that made the birth of humans genetically modified in an in vitro fertilization (IVF) center a theoretical possibility. Now, it appears it may already be happening. According to Chinese medical documents posted online this month, a team at the Southern University of Science and Technology, in Shenzhen, has been recruiting couples in an effort to create the first gene-edited babies. They planned to eliminate a gene called CCR5 in hopes of rendering the offspring resistant to HIV, smallpox, and cholera. He Jiankui leads a team using the gene-editing technology CRISPR in an effort to prevent disease in newborns. The clinical trial documents describe a study in which CRISPR is employed to modify human embryos before they are transferred into women’s uteruses. The scientist behind the effort, He Jiankui, did not reply to a list of questions about whether the undertaking had produced a live birth. Reached by telephone, he declined to comment.  However, data submitted as part of the trial listing shows that genetic tests have been carried out on fetuses as late as 24 weeks, or six months. It’s not known if those pregnancies were terminated, carried to term, or are ongoing. [After this story was published, the Associated Press reported that according to He, one couple in the trial gave birth to twin girls this month, though the agency wasn't able to confirm his claim independently. He also released a promotional video about his project.] The birth of the first genetically tailored humans would be a stunning medical achievement, for both He and China. But it will prove controversial, too. Where some see a new form of medicine that eliminates genetic disease, others see a slippery slope to enhancements, designer babies, and a new form of eugenics. Dr. Sullivan serves as professor of pharmacy practice and director of the Center for Bioethics. His research and writing interests include biomedical ethics, moral philosophy, and reproductive ethics. Contact him today for your story! Simply click on his icon to arrange an interview.

Virginia Tells Us Everything We Need to Know About Future Elections

Democrats increased their House majority over the weekend to a net gain of 37 seats -- and could still pick up at least one more. The final tally is close to what a political scientist at University of Mary Washington forecast a year ago when he created a statistical model based on the 2017 Virginia governor's election. Virginia, the expert argues, is the most important state in the nation, telling us everything we need to know about future elections. And non-biased statistical models are better forecasters than people.  Trumps tweets and behaviors don't matter. Elections are easily predicted by fundamentals: Presidential approval and what voters in swing states like Virginia have to say.  To learn more about the statistical model -- and why Virginia is so important in elections going forward -- contact Associate Professor of Political Science Chad Murphy at the University of Mary Washington. Simply click on his icon to arrange an interview.