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The Food and Drug Administration says it is re-examining the safety of a medication that was approved despite concerns that not enough was known about the drug's risks.In response to questioning at a budget hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid, which is the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis.The medication has been cited as a so-called "suspect" medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, as highlighted in a recent CNN report.The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago."What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.DeLauro pressed Gottlieb for answers on his agency's response to the safety concerns surrounding Nuplazid."How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?"Tracked by the FDA, the adverse event reports cited by DeLauro do not mean that a suspected medication has been ruled the cause of harm and are typically not the result of official investigations. But the FDA uses the information to monitor potential issues with a drug and can take action as needed: updating a medication's label, for instance, or restricting its use. In rare cases, the agency can even pull a drug off the market.When asked by CNN about what prompted the FDA's new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn't say what those factors were. Instead, it would only comment generally, saying that it identifies "potential signals of serious risk/new safety information" in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.But physicians, researchers and other medical experts told CNN that the high number of reports deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.Nuplazid's review was expedited by the FDA because it had been designated a "breakthrough therapy," meaning it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market.Dr. Paul Andreason, the physician who led the FDA's medical review of Nuplazid, warned that patients taking the drug during the company's clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.At that advisory committee meeting two years ago, one woman said that her grandmother had been part of the clinical trials for the drug and that Nuplazid had been life-changing."We didn't know what to expect or even if she was on the drug" or a placebo, said Zoey Wade. "We soon realized that she must be taking the drug, because she really returned to herself. Her hallucinations reduced, and she better understood what was real and what was imaginary."Shortly after Nuplazid's release, however, patients' family members, doctors and other health care professionals started reporting "adverse events" possibly linked to the medication -- including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue.During the first 10 months Nuplazid was on the market, 244 deaths were reported to the FDA in which Nuplazid was a "suspect" medication, according to an analysis conducted by the Institute for Safe Medication Practices. FDA data now show that the number of reported deaths has risen to more than 700. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.After CNN published its investigation on Nuplazid, reporters were contacted by family members who said the drug helped tame hallucinations with few apparent side effects and others who said they believe Nuplazid contributed to their family member's decline or death. Some said they had not yet reported these experiences to the drugmaker or the FDA.While the FDA has long been criticized for being too slow to approve drugs, DeLauro seized on its push to streamline the process, lambasting the agency for putting industry interests and efficiency above public health and safety.DeLauro described the number of adverse events and deaths as "staggering" and "unprecedented." She also expressed concern that the drugmaker, Acadia Pharmaceuticals, is attempting to get the drug approved for a larger population: patients who suffer from dementia-related psychosis."I don't know why it should stay on the market, especially when the FDA has not determined it to be safe and while the number of adverse events continues to soar," she told Gottlieb.In response to the congresswoman's remarks, Acadia told CNN that adverse event data alone are "not a comprehensive and accurate indicator of the safety profile of any drug." In response to CNN's earlier report on the drug, Acadia said there are a number of reasons for the higher volume of death reports, including the fact that the company distributes Nuplazid through a network of specialty pharmacies that puts the company in more frequent contact with both patients and caregivers -- meaning Acadia is more likely to receive reports of death, which it is required to pass along to the FDA.Commissioner Gottlieb told the committee that the FDA is careful about the decisions it makes and that there may be a higher tolerance for risk in situations where there is an unmet medical need, "so long as the patient is properly informed of what those risks are." This echoed what he told CNN's Dr. Sanjay Gupta in an interview earlier this month.The FDA previously told CNN that it was aware of Nuplazid's "complex safety profile" at the time of approval and required the drugmaker to place warnings on its labeling. The agency also said that, though it was continuing to monitor available information about Nuplazid, it had "not identified a specific safety issue" not already reflected on the medication's label.DeLauro's office told CNN that it plans to follow up with the FDA about its inquiry into Nuplazid. 7224

The conversation around wearing different protective gear is expanding. In particular, face shields.Teachers recently asked the nation’s top infectious disease expert, Dr. Anthony Fauci, about it and he said, “if you can get one, it’s not a bad idea.”Fauci went on to say that a shield shouldn't necessarily be worn in place of a mask, but more parents are considering the option for kids.“For some of the kids, a mask just isn't going to work. And in those cases, a face shield can be considered, but I think it needs to be understood that that’s not the default,” said Dr. Preeti Malani with the Infectious Diseases Society of America.Infectious disease experts say there just isn't enough data yet on how much protection a face shield provides.One study found it did significantly reduce the number of inhaled droplets, but cloth masks are also about protecting others. Shields were not as sure to do that as well.“If you're wearing a shield, the respiratory secretions that might be coming from your mouth or nose are not going to be as well contained,” said Malani.In the health care setting, face shields are used primarily to prevent splashing in the eyes.Malani offered this advice about finding the right shield.“It’s important that it’s long enough to really protect the whole face and that it wraps around fully and that it fits well up at the forehead,” said Malani.Companies, including Apple, Nike, General Motors, and John Deere have all started producing face shields.In a JAMA Network open viewpoint, it was pointed out that face shields have some advantages over masks. They can be reused indefinitely, they are easier to clean, they are comfortable, and they help prevent touching of the face. 1719

The Camp Fire is just the latest fire tragedy in California. Residents are still rebuilding in Wine Country more than a year after the destructive wildfires there.In the one year since Kelly Bracewell's Santa Rosa home turned to ash, she's figured out how to be happier. She’s also learned how to live without some of her most cherished possessions.As she rebuilds her own home, she works to help others who lost everything."As an interior designer, it’s been a great distraction,” she says.She says she wants to help put the community back together.Another community member, artist Gregory Roberts, is also using his talents to help people heal.One artist is using the ashes to help the people who lost their homes heal.“I was standing in the studio during the fires, and ash was falling all around,” Roberts describes.Roberts was certain that he, too, would lose his home. Fortunately, his house and pottery studio survived, but the ash raining down over Wine Country gave him an idea.“I wanted to be able to give people back something to let them know that your memories are not actually lost; your memories are all still intact,” he says.Roberts started collecting ash from lost homes. Ashes from 140 homes appeared in a plastic bin on his front porch, some with handwritten notes, of people wanting him to create art from their lost homes."Something from their home, because this idea that everything is lost is a hard one to overcome," Roberts says.Roberts says the ash remnants of homes are different, so the patterns and colors are never the same."I really want each one to be sort of its own unique animal,” Roberts says. “In the same way that each person's home is unique." 1691

The city of Albuquerque, New Mexico, is answering calls to "defund the police" by creating a new public safety department that will send unarmed social workers instead of police officers in response to some 911 calls.On Monday, Albuquerque Mayor Tim Keller (D) said his administration would form a new city department, Albuquerque Community Safety, whose personnel would respond to some emergency calls.Albuquerque Community Safety officials will respond to calls of inebriation, homelessness, addiction and mental health. According to Keller's office, the department will be made up of social workers, housing and homelessness specialists, violence prevention and diversion program experts.Officials hope the new department will keep such calls from escalating into violence and will allow police officers to re-focus their efforts to combating and investigating violent crime."We want to send the right resource to the right call," Keller said in a statement. "Especially where a social worker or trained professional can connect people with the services they need, instead of simply taking folks to jail or the hospital, which have been the only choices until now."According to The Washington Post, experts believe that the Albuquerque Community Safety department may be the first of its kind. Though calls to defund police departments have strengthened following the death of George Floyd in May, Keller says the city has been working for two years on to change the way Albuquerque handles some emergency calls.Activists who are calling for cities to defund police departments say that money would be better spent on community outreach. They also say that sending armed police into some emergency situations can escalate situations and lead to violence, especially against racial minorities and people of color.In recent weeks, thousands of protesters have taken to the streets in dozens of major cities, calling for an end to police brutality and systemic racism following the death of George Floyd in Minneapolis.Floyd died in police custody after allegedly using a counterfeit bill to buy tobacco while intoxicated. After handcuffing Floyd, bystander video shows a police officer, later identified as Derek Chauvin, kneeling on Floyd's neck for more than eight minutes. Chauvin has been charged with second-degree murder, and three other officers face charges in connection with Floyd's death. 2412

The COVID-19 pandemic is putting vacations on hold across the country. Luckily, Airbnb Experiences is offering a getaway that doesn't require leaving the house.The new program offers worldly activities with chefs, fitness trainers and other experts from various fields.Like coffee? Take a coffee lesson from a national judge. Need to relax? Try meditation, "guided with sleepy sheep." Or, learn how to meditate with a Buddhist Monk.There's yoga, wine tasting and cooking classes — but the dogs of Chernobyl experience is getting the most attention. The experience, guided by a Ukrainian native, introduces users to the dogs of Chernobyl — the second- and third-generation of wild dogs who were in the region when the nuclear disaster took place.It's been a rough year for Airbnb. In a business reliant on travel, COVID-19 was a huge hit for the company."When you're in travel and tourism and you get hit with a global pandemic there is no necessary playbook for that," said Chris Lehane, the Senior Vice President for Policy and Communications at Airbnb.But Airbnb has adapted. They've realized that people still need a way to escape while stuck at home.Airbnb has also seen a rise in customers traveling to rural areas within driving distance."Sixty percent of traveling in Airbnb is within 300 miles of where someone lives," Lehane said. "I say this as a father of two teenage boys — people are looking to get in their car and drive without stopping."Airbnb says one of its top "trending" destinations is southwest Michigan. Hannah Heyn and her family rent out four different places in Sawyer, Michigan on Airbnb."It's very special in the sense that there's a lot of breweries, wineries, beaches, trails," Heyn said, "It's a little treasure in our Midwest area, and when you love your area, you want to share it with others. And we love doing that."Airbnb is their primary source of income, and they're just now coming back from the rough stay-at-home spring. Now Heyn is booked through August, and the "Superhost" is learning new things about the place she calls home."We had a guy coming to learn how to make better and fancier chocolates, and I didn't know we had that," she said. "He was meeting with a top chef here to learn how to make delicate designs on chocolate."Airbnb has also introduced an "Enhanced Clean" option, which Lehane says gives hosts more control over their environments and allows vacationers to feel more comfortable."The protocol includes the types of equipment to use when cleaning, the type of chemicals you should use...really explaining and educating and providing protocol about the difference between cleaning, picking up clutter and dust-and-sanitizing," Lehane said. 2711