Organic food company Duchy Originals is to open its first bakery on 14 June producing new ranges including organic Cornish pasties and sweet and savoury tarts and flans (British Baker, 28 Oct. pg 6).The Cornish bakery, which was originally scheduled to open in April, will sell mainly to Waitrose and Budgens, and has been discussing a deal to supply Sainsbury’s, said a Duchy Originals spokeswoman. The bakery’s initial range will include steak and cheese & onion pasties; bacon & cheese and cheese & onion flans; and chocolate, lemon and fruit tarts. The plan is to double production within two years, in part through the addition of pastry products. Duchy Originals declined to give details of initial production capacity. The initial workforce of 14 will include 11 people on the two production lines. The bakery will use some ingredients sourced locally, including meat for pasties from local butcher James Kitto. It will also use some ingredients, including preserves and bacon, sourced from the suppliers of other Duchy products, a spokeswoman said. The Duchy Originals Foods Bakery in Launceston, Cornwall, is owned by the Prince of Wales’ estate, which up to now has subcontracted production of all its food and drink products to suppliers including La Fornaia and Walkers Shortbread.Duchy Originals was set up by Prince Charles in 1990 to sell oat biscuits to fund his charitable foundation.
At the launch event International Trade Secretary Liam Fox said: These consultations are about how we position ourselves as Global Britain. To build the export markets, investment opportunities and trading relationships of the future. Trade affects us all – whether it is through the prices and availability of product on our supermarket shelves, to the resources available for our public services, to the jobs and investment on which we all rely. You can now have your say on our prospective trade negotiations. Take part in the online consultations These agreements could: enable increased trade and investment secure access for UK exporters to the key markets of today and the future give consumers access to a greater range of products at lower prices make the UK more innovative, competitive and prosperous. Take part in the online consultations Watch our video to find out moreHow will the consultations work?The benefits of trade agreements Boosting economic growth in the UK by encouraging more competition, investment and innovation. Contributing to global prosperity, by boosting economic growth in countries that the UK does business with through international supply chains. Increased global prosperity supports social cohesion within and between countries, and in turn political stability, which is one of the building blocks of our collective security. Some trade agreements can particularly benefit developing countries – trade can be a vital tool in boosting developing countries’ economic growth and reducing poverty, while also providing UK consumers and businesses with goods at competitive prices. Trade is also an instrument of foreign policy and some countries use trade policy (including trade agreements) to advance standards and values. Trade agreements aim to reduce trade barriers between countries. Barriers can be taxes charged on goods as they cross borders (tariffs), or different rules and regulations that can add to trade costs (non-tariff measures). Trade and investment barriers make it more difficult and costly to trade or invest overseas. Reducing these barriers can help the flow of goods, services and money for investment between countries, and help businesses to access markets they previously weren’t able to. Consumers can benefit from access to a greater variety of products at lower prices.Trade agreements do not prevent governments from regulating as they see fit, and they also do not require governments to privatise any services. The UK Government is committed to maintaining our high standards for consumers, workers and the environment, and to protecting our public services, in any future trade agreements that we conclude. For the first time in over 40 years, the UK will be able to determine who we trade with and the public will have a say on the terms of these trading agreements.We want to maximise our trade opportunities globally and across all countries – both by boosting our trading relationships with old friends and new allies, and by seeking a deep and special partnership with the EU.In 6 month’s time, the UK will have the opportunity to begin negotiating, signing, and ratifying Free Trade Agreements to bring them into force from January 2021.In preparation for this, the UK Government is consulting with members of the public, businesses, trade experts, and any other interested organisations to help inform this work. This initial consultation process will inform our overall approach to our future trade relationship.There are 4 online consultations: Consultation on trade negotiations with the United States Consultation on trade negotiations with Australia Consultation on trade negotiations with New Zealand Consultation on the UK potentially seeking accession to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)
Social media has been set alight with talk of ‘the Asian answer to Greggs’, which will open in Cambridge this Saturday (15 July).Owned by sushi chain Wasabi, which runs 50 restaurants and sushi bars in the UK, the new bakery, Soboro, will serve Japanese and Korean pastries, as well as some “British favourites”, in The Lion Yard shopping centre.It will also offer sandwiches, coffee and soups at the 75-cover site.Darren Church, Wasabi business development manager, said: “We believe that British customers love to try anything different so long as it’s tasty and exciting – and that’s exactly what we have with Soboro.“The freshness and the quality of the offer is something we are confident will appeal to a significant proportion of the breakfast and lunchtime market. It’s not like anything else on the high street right now.”Soboro is the name of a Korean sweet bun.
New JJ Cale Compilation Of Previously-Unreleased Material Coming Spring 2019, Listen To Lead Single, “Chasing You”
The first posthumous compilation album of new recordings from the late JJ Cale is set to arrive later this year. Titled, Stay Around, the forthcoming album will feature 15 previously-unreleased original songs (and one cover) when it arrives on April 26th via Because Music.Stay Around will be the first posthumous album release from the Cale estate since the guitarist/singer died at the age of 74 in July 2013. The 15 tracks to be featured on the album were reportedly compiled by Cale’s widow, Christine Lakeland Cale, with assistance from his longtime manager, Mike Kappus. All 15 recordings on the album have never been released, and were written by Cale with the exception of a song called, “My Baby Blues”, which was penned by Lakeland Cale (recorded with JJ) back in 1977, the year they met. According to his widow, “My Baby Blues” should help to bring “everything full-circle.”Related: Remembering Leon Russell On The 2nd Anniversary Of His Death“‘Roll On’, the title track of Cale’s last studio album, was 34 years old,” Kappus mentioned in a statement about his old recordings. “He would burn me CDs of demos, and one time I said, ‘You’ve got two good albums on here.’ Some of the tracks had detailed information, some of them had nothing. Some songs might be a full band of his buddies, others were him playing everything. These were songs he really did intend to do something with because they were carried to his typical level of production for release.”The forthcoming album’s lead single, “Chasing You”, was released back on January 31st. The road trip-worthy single was written in JJ Cale’s living room with the band set up while rehearsing for his 2009 tour. Fans can listen to the song via its new music video below–which even features Cale himself as viewers are taken on a journey through cities across America while on tour with the famous rock guitarist back when he was still alive.JJ Cale – Chasing You[Video: JJ Cale]Fans can click here for more information on how to purchase Stay Around ahead of its April 26th release.JJ Cale – Stay Around Stay Around Tracklist:1. Lights Down Low2. Chasing You3. Winter Snow4. Stay Around5. Tell You ‘Bout Her6. Oh My My7. My Baby Blues8. Girl Of Mine9. Go Downtown10. If We Try11. Tell Daddy12. Wish You Were Here13. Long About Sundown14. Maria15. Don’t Call Me JoeView Album Tracklisting[H/T GuitarWorld]
Climate change is a “risk factor” for forced migration, like in the European refugee crisis, experts on health, migration, and disaster relief told a symposium Thursday, urging development of early warning systems and robust government responses to ease the effects of climate-related problems.Jennifer Leaning, the Francois-Xavier Bagnoud Professor of Health and Human Rights at the Harvard T.H. Chan School of Public Health, said that, although controversial in the 1990s, the idea that climate change can play a role in sparking mass migrations like the those in the world today has become more widely accepted.The extent of climate change’s contribution to the 66 million people on the move globally remains imprecise, but several experts said it is nonetheless important to include it in analyses of why people emigrate, what happens to them during their journeys, and how that affects their health.Ashish Jha, K.T. Li Professor of International Health and director of the Harvard Global Health Institute, described climate change’s impact on migration as akin to the effects of smoking and heart disease. It’s known that smoking is a risk factor for heart disease, but its contribution to any particular case compared with other factors, like diet, exercise, and heredity, is difficult to quantify. That doesn’t prevent physicians from warning against cigarettes, however.Scientists predict that climate change will not just warm the planet but also foster weather extremes, intensifying storms, and thereby making crop-killing droughts and flooding rains more common, heat waves hotter and longer, and sea levels high enough to threaten coastal dwellers, particularly during extreme tides such as those during hurricanes and other coastal storms.Leaning, director of the FXB Center for Health and Human Rights, said that good governance is a major mitigating factor in climate shifts, though she also said even countries like the United States, that have both wealth and effective governments, are at risk for the most extreme storms, like hurricanes Harvey, Irma, and Maria. The torrential, enduring rains from Harvey, she said, overwhelmed even Houston’s modern, effective governance, while Maria’s impact on the Puerto Rico, a U.S. territory, could lead to significant migration to the mainland.Leaning cited media reports that indicated thousands of Puerto Ricans had escaped to the mainland before the storm and that Maria’s destruction had so affected basic needs such as food, shelter, and employment that tens of thousands more — possibly even hundreds of thousands — could follow.“Climate change is already beginning to have an effect,” says Ashish Jha, director of the Global Health Institute. “By all measures, it’s only going to get worse.”Unlike other parts of the world, where the mass migration of one ethnic group can cause competition for resources and foster ethnic tension, in this case, she said, the U.S. East Coast is wealthy and has an existing Puerto Rican population, so she didn’t expect the influx to become a strain on the whole economic and governmental system.Leaning made her comments during a keynote talk at a half-day symposium called “Climate Change, Migration and Health” and sponsored by the Harvard Global Health Institute. The event, held at the Radcliffe gymnasium, also featured panel discussions on the topic and remarks by Jha.Leaning said that climate issues likely played a part in sparking the ongoing European refugee crisis, through a prolonged drought in northern Syria that devastated the agricultural livelihood of people there. Its effects were exacerbated by an inadequate government response that caused a million Syrians to migrate internally to cities where the majority population was ethnically different. Those cities, already stressed by the arrival of 1.5 million refugees from Iraq, were also the sites for rising unrest that led to Syria’s civil war, which caused millions to flee the country.Under current international law, Leaning said, those leaving their homelands for environmental reasons wouldn’t be considered refugees, a legal status reserved for those driven out because of race, religion, nationality, or politics. The label also doesn’t cover the many millions displaced from their homes who don’t cross international borders, but who nonetheless need help.Economic and organizational pressures stemming from the new arrivals can foster local unrest and even conflict. Warfare confined to a single country is particularly worrisome because it isn’t regulated by international strictures and is more prone to atrocities such as ethnic cleansing, war crimes, and genocide, Leaning said.“I won’t go into the way in which the world is awash with wars, and awash with weapons, and awash with young people who don’t have a sense of the future. We all know and understand this,” Leaning said. “It’s quite a direct link” to climate change. “It’s not the only link, and it’s not causal link, but there are associations between climate change, migration, entering alien spaces, conflict in those alien spaces, and then armed conflict.“We’re very much concerned with how you prevent these wars, which is why we’re cycling back to climate change.”Early warning systems, Leaning said, can give governments and international actors a chance to intervene before a dispute turns hot. Famine early warning systems are most advanced, and others — such as identifying atrocities — are being developed.Health care, human migration, and climate change are critical international concerns, Jha said. Health care constitutes a significant part of the U.S. economy. Migration has fed reactionary movements that, among other things, just led to election of far-right members to the German parliament for the first time since World War II. In addition, he said, the United States has just witnessed three major storms, each large enough to be historic in its own right, in line with climate predictions that they will become more frequent and intense.“Climate change is already beginning to have an effect,” Jha said. “By all measures, it’s only going to get worse.” McCarthy urges scientists to raise their voices on climate change Related Fighting words from former EPA leader The panelists discussed care for migrants and the need for action, even amid continued uncertainty about what moves will prove most effective. Elizabeth Donger, a research associate at the FXB Center for Health and Human Rights at the Harvard T. H. Chan School of Public Health, said it’s important to think hard about what happens to refugees when they arrive in their new homes. The practice of sending people to temporary camps is reflective of an expectation that their stay will also be temporary, which experience says is hardly always the case, Donger said.Statistics show that the typical stay of a refugee is 26 years, which makes it important that host nations don’t just warehouse them and instead provide education, job training, and work permits that allow them to become productive members of society.Harvard Humanitarian Initiative Director Michael VanRooyen, professor of emergency medicine and of global health and population, and director of the Emergency Department at Brigham and Women’s Hospital, said the impact of climate-related disasters will likely fall most heavily on the world’s poorest nations, which lack the resources of countries like the United States to respond.“We know there’s a direct link between the impact of disasters and human vulnerability,” VanRooyen said.Though more study is needed to understand better the climate-related risks to health — whether through famine, war, or storms — VanRooyen warned that uncertainty is not an excuse for inaction. Centuries of experience, after all, have shown where disasters are most likely to hit.“We work pretty closely with the Philippines, for example, and we know, predictably, the Philippines is going to be hammered by 25 major storms a year, and two or three of them will be epic in nature,” VanRooyen said. “Just because we’re uncertain doesn’t mean we shouldn’t act. Just because we can’t quantify it doesn’t mean it’s not real.”
National strategies are needed to help control spiraling costs, panel says, and examples exist Drug story When disease strikes, gender matters The solution, according to panelists at a session sponsored by the Harvard T.H. Chan School of Public Health, involves gathering more data to help identify specific health needs of the lesbian, gay, bisexual, transgender, and queer (LGBTQ) population, along with educating health professionals so they better understand that there are differences in care needs, and that ignoring them can do damage.“There’s a ton of research, including by my colleagues here at Harvard — David Williams in particular — showing that experiencing discrimination is associated with a whole range of negative health outcomes,” said Logan Casey, research associate at the Harvard Opinion Research Program. “So if you’re experiencing this discrimination on such a widespread scale and it’s having all these negative health impacts and then on top of that you’re not going to a doctor … that is going to compound the effects of discrimination.”The forum, “Health in the LGBTQ Community: Improving Care and Confronting Discrimination,” featured Casey; Kenneth Mayer, co-chair and medical research director of the Fenway Institute; and Sari Reisner, assistant professor of epidemiology at the Harvard Chan School. Wednesday’s panel was moderated by Joe Neel, science correspondent and deputy senior supervising science editor at NPR. It was co-sponsored by the Harvard Chan School and NPR.The poll by the Harvard Chan School, NPR, and the Robert Wood Johnson Foundation examined the experience of discrimination in several populations, including LGBTQ adults. It found that discrimination is a common feature in their lives, with 57 percent saying they’ve been subject to anti-LGBTQ slurs and 53 percent to offensive comments about their identity.,In addition, 51 percent said they or a friend or family member who is also an LGBTQ person have experienced violence. The same percentage said they’d experienced sexual harassment, while 57 percent said they’d received threats or been subject to nonsexual harassment. In addition, just over a third, 34 percent, said they’d been harassed verbally in a bathroom.“We see these extremely high numbers of interpersonal violence being reported by members of the LGBTQ community,” Casey said.Within this population, Casey said, there are further disparities based on race. Black LGBTQ people had higher rates than whites of discrimination on the job and in interactions with police, and more often avoided calling police when in need because they were concerned about discrimination. Infectious disease rates are higher as well, Reisner said, with an estimated 50 percent of black transgender women suffering greatly from HIV.Awareness of the differing health needs of the LGBTQ community is rising, panelists said. The National Institutes of Health has made the community a priority population for research into health disparities, which include an increased risk of adverse health outcomes at two to five times that of the general population, according to Reisner.Panelists agreed that more data is needed on the health care needs of the LGBTQ population. They said questions about sexual orientation and gender identity should be added routinely to surveys to help illuminate those needs.Mayer said one of the biggest hurdles this population faces involves how unprepared most medical professionals are to take care of them — despite a push to improve the health care industry’s “cultural competence” and better understand the everyday lives and pressures on ethnic and minority patients.“The biggest challenge is that the health care system is woefully unprepared to take appropriate care of LGBTQ people,” Mayer said. “It’s a dawning idea that needs to gain traction, that there’s also a whole field of sexual-gender minority health that providers need to have an understanding of.”,Though providers often are reluctant to ask patients questions about sexual preference for fear of embarrassing them, Mayer said a recent survey said that 90 percent of patients don’t share that fear. A simple open question on registration forms — “Do you have sex with men, women, or both?” — can give a physician information and help establish communication that might prove important in understanding and treating health needs.One reason for optimism, said Neel, is that medicine has “a learning attitude,” meaning many physicians — once they become aware that a need exists — extend effort to better care for patients, whatever their background.Mayer said doctors may be motivated to educate themselves if it is emphasized that failing to ask about and consider sexuality isn’t just a missed opportunity to provide better care, but could be a prescription for worse care.“I’m optimistic,” Mayer said. “The hook, and it’s the right hook for providers, is you’re going to do a better job providing patient care. Did you really go into this profession to do a bad job? I think if we can get people to understand that, that will help turn things around.” Sorrow, frustration, hope in opioid crisis Experts in Harvard Chan School discussion say research, treatment need to be more sensitive to differences between men and women Nearly a sixth of LGBTQ adults have experienced discrimination at the doctor’s office or in another health care setting, while a fifth say they have avoided seeking medical care out of fear of discrimination, according to a recent poll.That combination, in a population that commonly experiences discrimination and even violence in their day-to-day lives, can lead to a cascade of health ills, experts say. People who experience discrimination, for example, have been shown to have an increased risk of heart disease, and that risk can be raised further by skirting routine medical care. Harvard panels share experiences, ideas in health, policy, law enforcement Related
This is the fifth installment of an ongoing series “Sweet on Dell Technologies.” Co-authored with Jeff Clarke, Vice Chairman, Products and Operations, Dell Technologies.A few weeks ago, I was in New York for our Dell Technologies 2019 Business Update. It’s a given that we reviewed our company strategy and financials, but what we also wanted attendees to take away is the depth of our innovation. Innovation is nothing new for our business – it’s what our customers expect from us. And, the speed and scale at which we’re innovating and integrating across the Dell Technologies family to create the technology infrastructure of the future is what’s truly impressive.As we head into 2020, I look across our expansive Dell Technologies’ portfolio – one that has evolved alongside the needs of our customers with a company-wide vision to drive human progress. This vision has inspired us to develop solutions for customers that allow them to evolve their entire IT strategy to meet the demands of the Data Era. And true to the core of our beginnings, we build solutions to remove the complexity our customers face every day in a world where IT touches almost all aspects of business, from PCs, apps, services, clouds, the edge, security, AI and Machine Learning.So, with this in mind, for today’s episode of the ‘Sweet On’ blog, I’ve invited Dell Technologies’ Vice Chairman Jeff Clarke to provide his insights into how we approach innovation to deliver holistic solutions for our customers across Dell Technologies. Jeff has been immersed in Dell’s innovation evolution for more than 30 years – his perspective is one that I always enjoy, having had both a front-row seat to all the action – while also being right in the middle of it all.Dell Technologies recently held its annual Business Update for financial analysts and media in New York, where Michael Dell, Dennis Hoffman (our Senior Vice President of Corporate Strategy), Tom and I provided an overview of just how large our opportunity is in the market given the depth and breadth or our portfolio and capabilities.One thing I hope we made crystal clear to our guests at the event and those listening over the web – this is not the Dell of years’ past. This is a new, powerhouse Dell Technologies delivering innovation at the scale and speed of the Data Era.We are uniquely positioned in a world where data is driving insights and action, and as a result – customers are making big investments in their IT infrastructure in order to stay competitive. Our customers are investing in physical and virtual hardware, digital workspace solutions, applications, AI-enabled systems and services. These investments are borne out of the need to mobilize, analyze and utilize data as their greatest asset – and inspire and enable their workforce to deliver game-changing outcomes with the most potent tools, applications and resources.While I could spend more time on growth and revenue numbers behind that portfolio – I want to hover on how we’re investing in innovation in ways that are truly unique to Dell Technologies.In just the last five years, we invested more than $20 billion in R&D, with more than 25,000 patents and applications. And while hardware is our roots – we’re innovating across our portfolio to deliver infrastructure solutions and PCs that are fueled by intelligent software. Dell Technologies is home to more than 20,000 engineers, data scientists and PhDs – and 85 percent of them are writing software.The focus of all that innovation driven by ingenuity? Our customers. That’s never changed in my 32 years with the organization. We’ve long partnered with our customers to deliver solutions that don’t just stun and excite in a lab – they make a difference when applied to the real world. We take advantage of Open Innovation and Experience Innovation to deliver powerful systems and customer experiences that tackle the most poignant challenges our customers face today and what they expect to face in the next three to five years.However, what always changes are the needs of our customers – and man are they evolving at a pace they, and we, are working hard to keep up with. The rate of data growth is not slowing – and currently many organizations are managing upwards of five disparate IT systems to mobilize, analyze, protect and secure their data – creating complexity and a lack of data visibility. That’s all compounded when you consider the amount of data that will come from the edge in the next five years – and the need to drive your data management strategy across both the edge and the cloud.It’s that complexity that has our CTO and engineering teams fired up to deliver holistic solutions that simplify it all. And what’s even more exciting is that given the breadth of the Dell Technologies estate – we’re able to do just that. We have the unique ability to bring together the brightest minds and leading innovation across IT infrastructure, PCs, services, security, application development. We have the solutions to enable a hybrid-cloud strategy while at the same time extending compute for AI and Machine Learning workloads out to the edge. We have the partnerships throughout the broader ecosystem to extend innovation into vertical markets and continue to make investments into the next amazing breakthroughs in IT through our venture arm, Dell Technologies Capital.Take all of this and support it with the world’s leading technology supply chain and global finance arm, and our customers get unparalleled solutions and services to power their business. That’s Dell Technologies today – leading from the front in the Data Era.Editor’s note: To go deeper, check out Tom’s and Jeff’s recent presentations and transcript from the Business Update in New York at: https://investors.delltechnologies.com/events/event-details/dell-technologies-2019-business-update
The 26th annual Flyin’ Irish Basketball Invitational brought service men and women from across the country together for a weekend of friendly competition. Organized and staffed by members of Notre Dame’s Air Force ROTC program, the Invitational serves as the largest ROTC sporting event in the nation, with all teams guaranteed a substantial number of games, according to junior Angela Ferreira, coordinator of the event. “All ROTC branches the Army, Navy, Marines and Air Force [were] represented,” she said. “The teams play through their brackets so that everyone is guaranteed at least three games.” Teams from universities across the country, including Michigan State and Texas A&M, traveled to South Bend for the weekend to compete, Ferreira said. “Many of the teams are local, but Texas A&M comes in every year and almost always wins,” she said. “We have four teams from the Notre Dame Air Force ROTC, two ND Navy ROTC teams, one Tri-Mil team with ND Army/Navy/Marines and one cross-town team from Trine [University] who is in our same detachment.” Ferriera said the event connects students who will work in the same field after graduation. “We have boards set up [at the event] for seniors that have lists of people who know which job type they will have, like intelligence or analysis, so they can meet some of the people they’ll end up working with,” she said. “The juniors have just finished field training as well, so they have the opportunity to reunite with people they met there.” Additionally, Ferriera said the event provides an outlet for students to meet others whom they may not normally interact with. “We don’t have a lot of chances to interact with other detachments now, but we’re all going to be in the Air Force or Army or whatever branch together after this,” she said. Colton Kennelly, a freshman from Iowa State and a member of the university’s Air Force ROTC program, made the eight-hour trip to Notre Dame and enjoyed the interactive atmosphere. “It was my first time at the Invitational, and it was a lot of fun playing a lot of basketball,” he said. “It really makes the ROTC experience something beyond drill and marching stuff all the time.” Kennelly’s team lost to the ND Tri-Mil team in the semifinals Sunday, but he said the merit of the event was beyond winning or losing. “It was fun to bond with some of the guys, work on our teamwork and just have a good time,” he said. Sunday’s championship men’s game featured the Notre Dame Tri-Mil team against Texas A&M, with A&M pulling away in the overtime win. Additionally, the Notre Dame women’s Air Force team fell to Marquette’s Navy team in the women’s bracket final.
Nov 14, 2006 (CIDRAP News) – Mainly on the basis of reports from Japan, drug manufacturer Roche and US regulators are warning that influenza patients treated with oseltamivir (Tamiflu) may have an increased risk of self-injury and delirium.”People with the flu, particularly children, may be at increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior,” says a warning that Roche has added to its official product information, according to a company letter posted on the Food and Drug Administration (FDA) Web site.Oseltamivir, a neuraminidase inhibitor, is used both to prevent and to treat flu and is regarded as the best available drug for dealing with a potential pandemic strain of flu. The United States and many other countries are stockpiling it because of the pandemic threat.The warning follows an FDA review of 103 reports of neuropsychiatric adverse events associated with oseltamivir use between Aug 29, 2005, and Jul 6, 2006, of which 95 came from Japan. That compares with 126 such adverse events reported between 1999 and August 2005. About two thirds of the problems were in children and youth (younger than 17 years).A report by the FDA’s Center for Drug Evaluation and Research says the adverse events included three fatal falls—one in a 14-year-old boy who apparently fell to his death from a condominium balcony and two in men. Most of the events (60 of 103) were described as delirium with disturbed behavior. Other problems included “suicidal events,” panic attacks, delusions, convulsions, depressed consciousness, and loss of consciousness.The FDA and Roche both say the contribution of the drug to the adverse events is not known. The FDA report says influenza by itself can lead to neuropsychiatric disorders, but many of the problems reported, especially delirium and suicide attempts, were not typical of those associated with flu alone.Citing factors that seem to implicate oseltamivir in the events, the FDA said most of the problems occurred within a day after the start of treatment, and in many cases the physician suspected the drug was the cause. In addition, many of the patients recovered quickly after they stopped taking oseltamivir.”It is still unclear whether these neuropsychiatric events are drug-related only, disease manifestations alone, or a combination” of the two, the report states.The analysis notes that oseltamivir is used much more widely in Japan, with 24.5 million prescriptions from 2001 thorugh 2005, than in the United States, with 6.5 million prescriptions in the same period. In Japan the product information already includes a warning about possible psychoneurological problems.The FDA report expresses concern that if oseltamivir use in the United States increases to the levels seen in Japan, the number of adverse events will increase as well. “Therefore, it would be prudent to update the U.S. labeling to be similar in scope with the current Japanese labeling,” it says.The Japanese origin of most of the adverse event reports might suggest that the problems are related to genetic characteristics common in Japan, the FDA analysis says. But given the much greater use of the drug in Japan and the possibility of different surveillance practices there, the lack of cases reported in the United States doesn’t constitute good evidence for that hypothesis, it states.The FDA analysis was prepared for the agency’s Pediatric Advisory Committee, which is scheduled to meet Nov 16.The latest developments come about a year after that committee concluded that 12 deaths in Japanese children who had been taking oseltamivir were not related to the drug. The FDA said then that the deaths seemed to be part of a wave of flu-related encephalitis and encephalopathy cases in Japanese children that began in the mid-1990s, before the drug was approved. But the committee asked the FDA to continue monitoring the situation and report again in a year.See also:FDA advice about potential neuropsychiatric side effects of Tamifluhttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150758.htmRoche letter about possible riskshttp://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM153422.pdfFDA staff analysis of adverse-event reports concerning TamifluNov 18, 2005, CIDRAP News story “FDA panel: Children’s deaths unrelated to Tamiflu”
Viola “Toby” Brooks, 94, of Lawrenceburg, Indiana, formerly of Aurora, IN and Connersville, IN, passed away Thursday, March 3, 2016.She was born Sunday, June 19, 1921 in Campbell County Kentucky, daughter of the late Oliver Webster and the late Rosa Bachman Webster.Viola enjoyed being a homemaker, and loved antiques.She enjoyed home decorating and camping in her younger years. Viola enjoyed having yard sales, and browsing yard sales.Surviving are nieces and nephews, Jackie Steele Wurth of Independence, Ky, Linda (David) Pitstick, Lonnie (Sally) Steele, Merle (Sarah) Steele, Robert Steele, Donna (Clay) Montang.She was preceded in death by her husband, James Leslie Brooks; sisters, Jessie Yelton, and Helen Steele; and brothers, Edwin Webster, and Albert Webster.Graveside Services will be held at 11:00 am Friday, March 18, 2016 at River View Cemetery.Contributions may be made to the Alzheimer’s Association or American Cancer Society. Please call the Rullman Hunger Funeral Home office at (812) 926-1450 and we will notify the family of your donation with a card.