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Federal officials on Wednesday banned electrical shock devices used to discourage aggressive, self-harming behavior in patients with mental disabilities.The announcement from the Food and Drug Administration follows years of pressure from disability rights groups and mental health experts who have called the treatment outdated, ineffective and unethical. The agency first announced its intent to ban the devices in 2016.For years, the shock devices have been used by only one place in the U.S., the Judge Rotenberg Educational Center of Canton, Massachusetts, a residential school for people with autism and other psychiatric, developmental or mental disabilities. The FDA said Wednesday it estimates 45 to 50 people at the school are currently being treated with the device.School administrators have called the shocks a last resort to prevent dangerous behaviors, such as head-banging, throwing furniture or attacking teachers or classmates. The center has continued to use the shock devices under a decades-old legal settlement with the state of Massachusetts, but needs court approval before beginning use on each resident.School officials said in a statement they plan to challenge the government ban in court. A parents’ group also defended the practice and said it would fight the ban.“FDA made a decision based on politics, not facts, to deny this life saving, court-approved treatment,” the school said. Electric shocks and other painful or unpleasant treatments known as “aversive conditioning” were more widely accepted decades ago. But mainstream psychiatry now relies on behavioral modification, prescription drugs and other therapies that have proven more effective.“Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior,” said Dr. William Maisel, a director in the FDA’s device center, in a statement.The Rotenberg school has used shock devices carried in students’ backpacks, which were attached to their arms and legs via electrodes. School staffers could trigger a two-second shock to a patient’s skin by using a remote controller.Some patients from the Rotenberg center have compared the shocks to a bee sting or worse. The school has faced several lawsuits brought by families who said their children were traumatized by the shocks.Other parents say that the technique is the only thing that prevents violent, sometimes life-threatening behavior in their children.“We will continue to fight to keep our loved ones safe and alive and to retain access to this treatment of last resort which has allowed them to live a productive life,” said members of the Rotenberg’s parents association, in a statement. “There is simply no alternative.” The FDA, echoing psychiatric experts, said that the shock therapy can exacerbate dangerous behaviors and lead to depression, anxiety and post-traumatic stress disorder. Patients have also suffered burns and tissue damage due to the device, the agency said.Regulators said patients should instead receive treatments that focus on eliminating factors that trigger the behaviors or teaching patients coping skills to deal with them. The FDA has only banned two other products in more than 40 years of regulating medical devices -- powdered surgical gloves, which can cause allergic reactions, and fake hair implants, which caused infections and didn’t work. Typically, the FDA addresses safety issues by adding new warning labels or modifying instructions for devices. But the agency concluded that the problems with the shock devices could only be addressed by banning them.___Follow Matthew Perrone on Twitter: @AP_FDAwriter___The Associated Press receives 3717
Harley-Davidson is trying to attract a new generation of riders at a very young age. The iconic motorcycle company announced Tuesday that it was buying StaCyc, which makes two-wheel electric bikes for kids.StaCyc has two models -- the 12eDrive and 16eDrive -- that the company describes as "the perfect choice for little rippers" between the ages of 3 and 7.The bikes have a top speed of about 10 miles per hour and sell for a range of 9 to 9.Harley-Davidson said in a statement that Harley-Davidson branded versions of StaCyc's two models will be available at select Harley-Davidson dealers in the United States in the third quarter of 2019."The StaCyc team shares the same vision we have for building the next generation of riders globally and we believe that together, we will have a significant impact in bringing the fun and enjoyment of riding to kids everywhere," said Heather Malenshek, Harley-Davidson senior vice president of marketing and brand, in the statement. Harley-Davidson is increasing its bets on electric vehicles as sales of traditional bikes slow.The company has already announced plans to launch the LiveWire premium electric motorcycle this fall. It is also developing other electric bikes that it plans to start selling in 2021.Harley-Davidson needs new growth opportunities as the company struggles to deal with tariffs from the Trump administration that have hurt earnings.Sales and profits are expected to fall this year and revenue is only expected to rebound slightly in 2020.Shares of Harley-Davidson have rallied this year with the rest of the market, rising 10% so far in 2019. But the stock is trading nearly 20% below its 52-week high. 1720

Flip or Flop, Fixer Upper and Property Brothers are some of the most popular shows on television. They all are based around the same concept: a family gets a home in disarray, completes a major renovation, and either sell it for a big profit, or live in it.Though, perception is sometimes deception.“They’re beautiful homes and everything, but it’s just not reality,” said Travis Tomlinson, owner of Lokal Real Estate.Tomlinson has been buying, flipping and selling homes for years in Northeast Ohio. He even holds classes for people wanting to learn how to get into the business. He said it’s not uncommon to have clients believe they can do more than they should, faster than they should, and end up getting in over their heads.‘It’s kind of flooding the market, actually,” he said. “They get themselves in a real bind because they don’t have the experience and they don’t have the knowledge.”According to Tomlinson, the first mistake most rookie flippers make is overpaying for the property.“If you purchase wrong it’s really hard to make a profit on it,” he said.Marnie Mekruit is a staging professional and works with Staged by L, a local company that stages flipped homes for clients. She said if you overpay right away, you’ll have less money for unforeseen bumps in the road and for important steps like staging.“If you’ve ever done a small home improvement in your house, like refinished your bathroom, you know, it took six months longer than you ever thought it was going to take and it ends up being twice as expensive as you thought it was going to be,” said Mekruit. “Extrapolate that to a whole property and all of the problems that can happen, all the things that come up that you just never plan for, and many people are just not prepared for that.”Professionals note that the timeline of the shows can be a little unrealistic.“They come in with a team of 15 to 20 guys and they're getting done in one day what it takes me maybe a week to do,” said local contractor Curt Yoder.While the flips are beautiful and extravagant, it’s best to start small.“A lot of people maybe go too far on the renovations they plan on doing,” Tomlinson said.Laura Fulton, a staging professional and the owner of Staged by L, echoed his sentiment.“A lot of times what they’ll do is they’ll either under budget or they’ll over improve,” said Fulton.But she said perhaps the biggest misconception on television vs. reality is the profit.“It's not realistic you're going to make that money,” she said. “Maybe in certain areas, California, and other places you can, but for our area, typically, you don't see those kind of profits.” 2636
HOUSTON, Texas – Early Friday, NASA astronauts Jessica Meir and Christina Koch will conduct the first all-female spacewalk outside of the International Space Station. The spacewalk will begin at 7:50 a.m. ET and last for about five or six hours.In order to tell the astronauts apart, Koch's helmet camera views will bear the number 18 and Meir's will be number 11. Koch's spacesuit also has red stripes on it.This will be the fourth spacewalk for Koch and the first for Meir.WATCH THE SPACEWALK LIVE BELOW: 518
House Intelligence Chairman Adam Schiff on Tuesday called the State Department's blocking testimony of a key witness "strong evidence of obstruction" of Democrats' impeachment investigation, and the move is prompting House Democrats to issue a subpoena for the testimony in response.The State Department on Tuesday directed US Ambassador to the European Union Gordon Sondland not to testify before Congress, scrambling Democrats' impeachment investigation and raising questions about whether they will be able to obtain testimony from other witnesses. But Schiff's sharp response to Sondland's absence is a sign of the escalating impeachment fight between the White House and Democrats."The failure to produce this witness, the failure to produce these documents, we consider yet additional strong evidence of obstruction of the constitutional functions of Congress," Schiff told reporters.In addition to blocking Sondland's testimony, Schiff said the ambassador indicated he had text messages or emails on a personal device provided to the State Department that State was withholding from Congress, which Democrats also planned to subpoena.Sondland's attorney Robert Luskin said State directed Sondland not to testify early this morning."He is a sitting ambassador and employee of State and is required to follow their direction," Luskin said. "Ambassador Sondland is profoundly disappointed that he will not be able to testify today. Ambassador Sondland traveled to Washington from Brussels in order to prepare for his testimony and to be available to answer the Committee's questions."Republican Rep. Jim Jordan of Ohio, the top Republican on the Oversight Committee, said he understood why the administration blocked Sondland's testimony, charging that Schiff wasn't running a fair investigation and that he was selectively releasing text messages from former US special envoy to Ukraine Kurt Volker. Republicans are calling on Schiff to release Volker's interview transcript."I'm all for bringing the ambassador in, but let's only do so after we release the full (Volker transcript)," said Republican Rep. Mark Meadows of North Carolina.Asked whether he had concerns about the President asking the Ukrainian President and China to investigate his political opponents, Jordan said Trump was "doing his job.""When you're talking about the hard-earned tax dollars of the American people going to a foreign government, the President's going to make sure that there's no corruption there," Jordan said. "He's doing his job, his duty as the commander in chief, his duty as the President of the United States, so I don't have a concern there."Jordan added that he believed the public had a right to learn the identity of the whistleblower, given that the allegations could lead to impeachment of the President.Trump said on Twitter that Sondland should not testify before a "kangaroo court.""I would love to send Ambassador Sondland, a really good man and great American, to testify, but unfortunately he would be testifying before a totally compromised kangaroo court, where Republican's rights have been taken away, and true facts are not allowed out for the public...to see," Trump tweeted.'The days of playing nice are done'Sondland was set to testify behind closed doors before the House Intelligence, Foreign Affairs and Oversight committees as part of the 3373
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