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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follows years of pressure from disability rights groups and mental health experts who have called the treatment outdated, ineffective and unethical.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
Flooding, mudslides and snow closed several highways in California over the weekend, with more rain and snow set to hit later in the week.The 154
House Democrats will vote on a legislative package to reopen the government when they take over the chamber on Thursday, a Democratic aide confirms to CNN.The Democrats plan to vote on six Senate spending bills and a stopgap measure to re-open the Homeland Security Department at its current funding levels until February 8, the aide said. The temporary measure would maintain the current .3 billion in border security money.Senate Majority Leader Mitch McConnell has made clear he will not move forward on any legislation until President Donald Trump signs off on it. The move by House Democrats, however, will have the effect of jamming Senate Republicans and the White House as talks for a compromise agreement to reopen the government remain at an impasse.Senate Democrats support the House Democratic plan, and Senate Minority Leader Chuck Schumer and expected incoming House Speaker Nancy Pelosi have been in constant contact and are on the same page on the plan, a senior Senate Democratic aide said.Democrats believe it's smart to separate Department of Homeland Security funding — and the wall fight — from the other six bills because they think it puts Trump and the Republicans in the position of holding the other agencies and furloughed workers hostage for the wall, the aide said. Democrats believe pressure will mount on Republicans as the shutdown drags on, the aide said. 1402
HOWELL, Mich. — A breastfeeding mother is speaking out after she was denied entry into the Little Caesars Arena in Detroit for the Ariana Grande concert because she had her breast pump with her. The Michigan mothers says the venue ultimately did right by her but it wasn't until after the concert. She hopes other businesses will educate themselves so other mothers won't have the same experience. “I had called before the Ariana Grande concert to make sure that my breast pump would be able to be brought into the facility," Kate Aulette said. "‘Absolutely, it’s a medical device. You’ll have no problems bringing it in.’"But that turned out not to be the case after the 2017 bombing attack at one of Grande's concerts in Manchester, England. Twenty-two people were killed and more than 100 people were injured. “The gentleman had said, ‘No. We’re not going to allow you to bring that in. You would need to have your baby with you if you wanted to bring that device in,’ " Aulette said. "So that really threw me off because that was the whole reason I was bringing my pump is because I wasn’t bringing my daughter with me to the concert.”Aulette said she returned to the bus that drove her to the concert from Howell, Michigan, and pumped her milk. She was then allowed into the show.Little Caesars Arena responded to the incident in the following statement: 1372
Good job getting in front of this baseball and protecting the beer, my guy. pic.twitter.com/dkQLZPjaMp— Cut4 (@Cut4) October 28, 2019 145