The black box warning would not apply to Strattera, manufactured by Eli Lilly and Co. That drug is not a stimulant. Novartis said Ritalin, approved by the FDA in 1955, is safe and effective. A company review of more than 50 years of records shows no apparent increase in cardiovascular problems associated with the drug’s use, according to Novartis’ medical safety director, Dr. Todd Gruber. He told the committee that the drug’s label advises caution in patients with certain pre-existing heart conditions. The FDA had asked the advisers to consider ways of studying the drugs because agency data suggested that the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks. The committee, however, quickly began debating whether it should consider new warnings for the drugs rather than the need for more studies. Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, told fellow committee members they should recommend the black-box warning. Nissen said his suggestion was meant partly to slow what he characterized as the “out-of-control growth” use of the drugs. The drugs already carry warnings related to the possible risk they could pose to patients with heart defects. “We feel this warning is appropriate given our current knowledge of these drugs,” said Dr. Gerald DalPan, a division director in the FDA’s Center for Drug Evaluation and Research. The FDA review that found 25 reports of deaths among the drugs’ users between 1999 and 2003 also uncovered 54 cases of serious cardiovascular problems, including heart attacks, strokes, hypertension, palpitations and arrhythmia. Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension. The FDA’s review found fewer than one reported death or life-threatening injury for every 1 million prescriptions filled for the drugs. Sales of ADHD drugs rose from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a pharmaceutical information and consulting firm. About 2.5 million children between ages 4 and 17 take ADHD drugs, according to federal survey data cited by Dr. Andrew Mosholder, a medical officer in the Office of Drug Safety. The survey found that 9.3 percent of 12-year-old boys and 3.7 percent of 11-year-old girls take the drugs, Mosholder said. Adult use of the drugs grew 90 percent between March 2002 and June 2005, he said. 160Want local news?Sign up for the Localist and stay informed Something went wrong. Please try again.subscribeCongratulations! You’re all set! WASHINGTON – Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they might be linked to an increased risk of death and injury, federal health advisers said Thursday. A Food and Drug Administration advisory panel voted in favor of the “black-box” warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote of the Drug Safety and Risk Management advisory committee was 8-7, with one abstention. One committee member, Dr. Curt Furberg, a professor of public health sciences at Wake Forest University Baptist Medical Center, said it would be “inappropriate, unethical behavior” not to disclose that there was uncertainty about the safety of the drugs. The FDA is not required to follow the recommendations of its advisory committees but typically does. AD Quality Auto 360p 720p 1080p Top articles1/5READ MORESanta Anita opens winter meet Saturday with loaded card “The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way,” Dr. Robert Temple, director of the FDA’s Office of Medical Policy, told reporters after the meeting. Doctors prescribe the drugs to about 2 million children and 1 million adults a month. Drugs that would have to carry the warning labels are methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The labels for Adderall and Adderall XR, both amphetamines, have included the warnings since 2004. The advisory committee also recommended that the drugs include a medication guide for patients and parents. The vote on that was 15-0, with one abstention. Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Other companies make generic versions of Ritalin.
24 June 2011 US First Lady Michelle Obama on Thursday praised South Africans who had grown up under apartheid, overcome the oppressive system, and built a country based on equality that had become a role model for the rest of the world. Speaking at Fuller Hall at the University of Cape Town (UCT) to pupils from five schools across the city, Obama said people of the world were looking to South Africa to become a world leader, and that many Americans were behind the country. “No matter what part of the world you come from, you can have an impact,” she told the pupils, pointing out that South Africa was the continent’s leading economy and had last year hosted a successful World Cup. She pointed to former president Nelson Mandela, who had in his lifetime seen what he had been fighting for all his life come to fruition. Obama also said the thoughts and prayers of her and her family were with the family of struggle veteran Kader Asmal, following his passing on Wednesday. She praised former UCT vice-chancellor Rampele Mamphele, who acted as a moderator during question-and-answer time from pupils. Mamphele, she said, was a “true role model” who had overcome racial discrimination during apartheid, becoming a doctor and collecting degrees, fellowships and awards from some of the most prestigious universities in the world.‘It takes hard work – and vision’ Obama said through hard work the youth of today could achieve their dreams. “There is no magic dust that helps students achieve at a place like this, nowadays it is more how hard you can work and, more importantly, it’s about believing in yourself every step of the way.” She said even after getting accepted at a top school, despite her disadvantaged background, she still had doubts she could succeed, until she began seeing that she was performing just as well as others. “I realised then that success isn’t about how much money you have or where you come from, but how hard you work,” she said. A good education was the only route to true success, as was the ability to be able to envision one’s dreams, she added. “The one thing I always say is that you have to practice success, it doesn’t just show up,” she said, adding that pupils needed to begin practicing early on, habits that built success. She said her highest priority when she travelled around the world was to meet with young people, and she came away inspired when speaking to young pupils.‘Realise what’s possible’ It was why she had organised to have the pupils come to UCT, because she wanted them to have the chance to walk around the university’s campus and meet professors and students to realise they could fit in there too. She said children rose to the bar that they were given, and wouldn’t be able to aim high if they were never shown what was possible, including being able to visit universities like UCT. In answers to questions raised by pupils, Obama said her mother – in her first trip to Africa – had been the perfect role model who had given her unconditional support and love. “As you get older, remember that the family you build can be the greatest contribution you make to the world, so never shirk on that responsibility,” Obama said. Obama said the relationship between South Africa and the US was strong, pointing out that more and more students were travelling to one another’s countries to study, adding that travelling was a good way to “expand one’s horizons”.Started by turning Barack down She said she felt “deep, deep responsibility” for being the first black American First Lady: “I was actually trying to talk my husband out of office, but now that we’re here I want to make the most of it,” she said. She said when her husband had first asked her out on a date, she had turned him down, because they were working in the same law firm together and she had thought it a “bit strange” that they go out. But she said she had later agreed to go out with him when she saw the kinds of values he had. “He was a community organiser and had a real passion for change, and he added something to my life,” she said. She advised the pupils to ensure that whoever they decided to be with romantically, added value to their lives. Source: BuaNews
20 August 2015In addition to offering schools, libraries and public areas free wireless service, Tshwane’s ground-breaking Free Public Wi-Fi initiative, run by non-profit organisation Project Isizwe with the City of Tshwane and several partners, is now bringing a much needed technological and social connectivity to the city in the interests of better service delivery and social cohesion.The public Wi-Fi facility, which has been running for over a year, is also available at the city’s health facilities, customer and municipal centres, tourism and heritage venues, as well as sites on buses, taxis and trains. The city has now launched three new user services: Wi-Fi Voice, Drive-In and Chat.The Wi-Fi Drive-In service will stream films and other programming to personal devices in public areas such as parks, events venues and other public gathering areas. Like traditional drive-ins, the service is aimed at bringing people together for a shared community experience.The first Drive-In programme is currently available at the Fountains Valley public park during the venue’s popular weekend flea market. The service has a catalogue of 30 free movies to choose from, with 10 new titles added monthly. There will be an emphasis on locally produced content in several languages. The number of venues where the streaming service is available will also be expanded over the coming months, covering the whole Pretoria/Tshwane region.Zahir Khan, Project Isizwe COO, says the idea behind it was to create a community and family experience, giving the people of the city an opportunity to gather in a secure, fun environment, “where citizens can break away from their usual routine and engage in a unique, ground-breaking experience.”The Wi-Fi Voice service allows users connected to the Tshwane Free Wi-Fi network to make unlimited free calls to other users, as well as connect to the city’s utilities customer-care line.Wi-Fi Chat, much like the Whatsapp and WeChat messaging apps, is a web- based platform for instant chat between users and a service delivery platform for city queries and information.“The high cost of voice calls and messaging creates a barrier to stimulating economic growth and creating opportunity for our youth,” says Khan, “the City of Tshwane will effectively reduce the cost of doing business in and with the city through the Tshwane Wi-Fi Voice and Chat apps.”With over 700 live Wi-Fi sites (and growing) across 95% of the city wards in the city, the Tshwane Free Public Wi-Fi service has over 720,000 unique users, making more than 22 million connections, enabling every citizen to be digitally included and part of the digital economy, regardless of personal circumstance. The mayor and Project Isizwe hope that the long-term benefits of increased GDP, productivity and efficiencies from service delivery ultimately make the citizens of Tshwane the best connected people in South Africa.Source: Screen Africa
Share Facebook Twitter Google + LinkedIn Pinterest After hearing concerns from membership nationwide, the National Cattlemen’s Beef Association (NCBA) is addressing the CME Group about volatility in the cattle markets. Increased volatility caught the attention of producers at the end of 2015 and it remains a concern.“This volatility is absolutely killing our producers who are trying to use these tools to manage risk and we keep hearing from our members that because of the price swings, even the tool that’s used for risk management is not as effective as it once was,” said Colin Woodall, NCBA senior vice president of government affairs. “Our members have demanded that we move forward and try to find some sort of solution.”The initial effort from NCBA was a letter to the CME Group asking for some significant changes. NCBA has asked CME to address specific areas of concern including implementing a delay between trading actions, greater enforcement against market spoofing, monitoring and reporting of market misuse, and the release of audit trail data.“Our success from that letter was not as robust as we had hoped,” Woodall said. “We only got CME Group to change one thing at the time and that entailed putting in place a messaging limit, which would cap how many trades any one firm could make in a single day. Even though that did help to manage volatility to a degree, we saw that volatility come back in the spring and summer of this year.”That caused NCBA to put together a CME working group at their annual meeting in San Diego. Since then, the working group has been split up into three sub groups. One group is looking into price volatility, another is investigating price discovery in the marketplace and the third group is seeing if the specifications of futures contracts need to be changed.“There is no one silver bullet,” Woodall said. “In fact, the question of ‘what will fix this issue’ is one that we ask every day. We when put together ideas that we think will work, we will push that through our policy process and see if we can get those changes implemented.”Risk management options like cattle futures are very valuable to producers across the country and NCBA members have been clear that they want these tools to stay, but they also want them to work.“CME has made it very clear to us that they want to fix these contracts and make sure that we are satisfied with the way these contracts work,” Woodall said. “The idea of taking these contracts and moving them someplace else may sound like a very good knee-jerk reaction, it’s not an action that we want to see in this overall effort. That’s why it’s important that we continue to work with CME to find a true fix.”The entire NCBA/CME working group will convene as a whole in October to begin molding some final solutions.
Share Facebook Twitter Google + LinkedIn Pinterest National Farmers hosted their 2018 National Convention at Great Wolf Lodge near Cincinnati earlier this week. The event kicked off with a program known as FarmStarts – an agricultural speaker series with a special focus on informing young and beginning farmers. FarmStarts has an emphasis on organic dairy and grain production. Ohio Ag Net’s Joel Penhorwood was there and talked to a number of the speakers and guests in attendance on the latest trends in organic production and what has been top of mind for those in National Farmers.
Tourism has suffered a major jolt in Kashmir on Sunday. Against an average footfall of 3,000 tourists per day just the previous week, a trickle of 350 arrived in the Valley, despite the adverse advisory.A Tourism department official told The Hindu that most hotels in tourist hotspots including Gulmarg and Pahalgam had been emptied following the advisory.“Around 700 tourists are still in the Valley after helping around 90% tourists to leave Kashmir in the past two days. We expect 350 more to leave by Monday given their flight schedules. Thereafter 350 will be left. All arrangements have been made for those who want to leave the Valley safely,” said a senior tourism official.According to data, Kashmir witnessed a major drop in tourists after the Pulwama attack in February, which witnessed India and Pakistan entering into a border duel.Steady growthHowever, April, May, June and July saw a steady growing numbers, from 17,172 in April to 60,844 in May and 1,16,572 in June and around 2 lakh in July, the official figures suggest.Kashmir Chamber of Commerce and Industry general secretary Farooq Amin said the sudden advisory had proved “Operation Bedlam” for people and the State economy.“The change in policy has been evident from February 2019. Since then tourism, horticulture and other sectors of our economy suffered tremendous losses due to the decision of the government to restrict movement of civilians on the only road link of Srinagar-Jammu. It has hit the final nail in the coffin now,” he said.
Portugal Iniesta warns Spain of Ronaldo danger at World Cup Ronan Murphy 17:48 6/12/18 FacebookTwitterRedditcopy Comments(0) Getty Images Portugal Cristiano Ronaldo Portugal v Spain Spain World Cup The ex-Barcelona midfielder is wary of facing the Real Madrid forward when La Roja begin their tournament against Portugal on June 15 Andres Iniesta has warned Spain of the danger of facing Portugal and Cristiano Ronaldo in their opening game at the 2018 World Cup.Spain begin their tournament campaign against their neighbours on June 15 in Sochi and team captain Iniesta is wary of facing the Euro 2016 champions.Iniesta has faced Ronaldo many times in El Clasico, knowing exactly what the five-time Ballon d’Or winner has to offer for club and country. Article continues below Editors’ Picks Out of his depth! Emery on borrowed time after another abysmal Arsenal display Diving, tactical fouls & the emerging war of words between Guardiola & Klopp Sorry, Cristiano! Pjanic is Juventus’ most important player right now Arsenal would be selling their soul with Mourinho move The midfielder also urged his team-mates to be fully focused in all their games as he fears the matches will be tight affairs, particularly the opener with Portugal.”Portugal is a team that takes a lot to defeat and we will have to perform at the highest level, in a World Cup any small thing can knock you out,” Iniesta told Cadena Cope .”Cristiano is a fundamental player for any team he is in and for Portugal as well.”Iniesta called time on his Barcelona career this summer, leaving Camp Nou for Vissel Kobe after 16 seasons at the club. Despite turning 34 in May, he has not yet fully decided if he will hang up his boots on international football after this summer’s World Cup.However, he admits that it may be the right time to finish playing international football, especially as he will be playing in Japan from next season.”I will never close one hundred percent the door of the national team after the World Cup, but everything indicates that this will be the case,” he admitted.During his time at Barcelona, Iniesta won 32 trophies, including four Champions Leagues and nine La Liga titles, playing 674 times for the Blaugrana.He admits that leaving the club was very difficult for him, but he has enjoyed his last moments at Barcelona. Iniesta also believes that Barca president Josep Maria Bartemou hopes he can finish the season with another trophy – the World Cup – although thinks that if Argentina and Lionel Messi win instead, the club chief will still be pleased.”These weeks of farewell have been very intense, emotionally very powerful, and I have tasted them to the fullest,” he said.”I understand that Bartomeu wants me to win with a national team that contains many Barca players. I suppose if Spain wins he will be happy, but if Argentina wins he will be happy too.”