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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 Environmental Protection Agency blocked reporters from several news outlets from a national summit on Tuesday where Scott Pruitt, the agency's chief, was speaking.Journalists from CNN, the Associated Press and E&E News, a publication that covers energy and environment issues, were barred by the EPA from entering the event, which was focused on harmful chemicals in water. A handful of other reporters from other news organizations, however, were allowed inside the event for Pruitt's opening remarks after having been previously invited by the agency the day before.In a statement, Jahan Wilcox, an EPA spokesman, said the agency barred reporters from attending due to space limitations inside the venue. He said the EPA was able to accommodate only 10 reporters and that it provided a livestream "for those we could not accommodate.""This was simply an issue of the room reaching capacity, which reporters were aware of prior to the event," Wilcox said.A report published by The Hill, however, said a handful of seats in the press section remained vacant by the time Pruitt began speaking. Another reporter told Politico there were dozens of empty seats in the room, and a photo obtained by CNN also showed space for cameras.Additionally, the Associated Press said in a story that one of its reporters, denied entry, was grabbed by security guards and forcibly shoved out of the building after asking to speak to an EPA public affairs person. A CNN photographer saw the female journalist being shoved out of the building by a uniformed guard, and the Associated Press journalist recounted the incident to CNN immediately after it took place.When reached by phone and asked about the Associated Press report, Wilcox declined to comment to CNN beyond his original statement, which said he was "unaware of the individual situation that has been reported."CNN was also blocked from attending the summit. A CNN photographer was screened by security guards before the event and was waiting for an escort or further information. Wilcox arrived soon after and provided security with a list of news outlets and reporters, instructing them not to let anyone not on the list into the event. The CNN photographer then asked if he could enter the event and was told by security he couldn't.Separately, a CNN reporter and producer lined up with members of the public and presented their IDs and credentials, identifying themselves as reporters. The individual manning the door said he needed to ask the press office if they could be permitted to enter. A few minutes later, he returned and said the CNN journalists were not allowed in.In a statement, a CNN spokesperson said, "Today, CNN was turned away from covering the PFAS National Leadership Summit at the EPA after multiple attempts to attend. While several news organizations were permitted, the EPA selectively excluded CNN and other media outlets. We understand the importance of an open and free press and we hope the EPA does, too."Sally Buzbee, executive editor of The Associated Press, said in a separate statement, "The Environmental Protection Agency's selective barring of news organizations, including the AP, from covering today's meeting is alarming and a direct threat to the public's right to know about what is happening inside their government."Buzbee added, "It is particularly distressing that any journalist trying to cover an event in the public interest would be forcibly removed."Following the media firestorm, the EPA reversed course and opened the second portion of the summit, which Pruitt was not scheduled to speak at, to the press. 3621

The funeral for Rayshard Brooks — an Atlanta man who was killed during an altercation with police earlier this month — took place Tuesday in a church with connections to the Civil Rights movement.Brooks' funeral was held at Ebenezer Baptist Church in Atlanta — the same church where Rev. Martin Luther King Jr. served as a co-pastor between 1960 and 1968.Dr. Bernice King, one of Martin Luther King's daughters, spoke during Brooks' funeral.Actor, writer and producer Tyler Perry provided the funds for Brooks' funeral. The funeral comes after an hours-long public viewing on Monday afternoon.Brooks was shot and killed in a Wendy's parking lot by former Atlanta Police Officer Garrett Rolfe on June 12. Rolfe's partner, Officer Devin Brosnan, first encountered Brooks after Brooks had fallen asleep in his car while waiting in the restaurant's drive-thru line.Rolfe arrived on the scene a few moments later. The officers subjected Brooks to a field sobriety test, which he failed. He later offered to lock his car and walk home, but Brosnan and Rolfe told Brooks they would be taking him into custody.As the officers attempted to handcuff Brooks, a struggle ensued. Brooks was able to grab Brosnan's stun gun and attempted to flee the scene. As he fled, Brooks appeared to point the stun gun in the direction of the police. That's when Rolfe shot Brooks in the back. Brooks later died in surgery at a local hospital.Fulton County District Attorney Paul Howard says Rolfe kicked Brooks after shooting him but before calling for emergency medical help. He also alleged that Brosnan stood on Brooks' shoulder. Both face charges in connection with Brooks' death, with Rolfe facing murder charges. 1701

The family of Jacob Blake is hosting a gathering in Kenosha, Wisconsin on Tuesday ahead of President Donald Trump's visit to the city.The event, which will be held near the site where Blake was shot seven times in the back by a Kenosha police officer, will include a press conference with local officials and family representatives. The event will also include a community clean-up, a food drive, a healing circle, and a voter registration booth.Several days after police officers shot Blake during an Aug. 23 altercation, protests in Kenosha grew violent. The city estimates that million in property damages have been caused by looting and burning amid the unrest.Last Tuesday, 17-year-old Kyle Rittenhouse shot three protesters, two of them fatally, after he drove 20 miles to protect local businesses. Rittenhouse has been arrested in connection with the homicides; his lawyer says that Rittenhouse was shooting in self-defense.In recent days, protests in Kenosha have been peaceful and without incident.The event held by Blake's family comes hours before a visit to the city by President Donald Trump. Several Democratic politicians, including Kenosha's mayor and Wisconsin's governor, have asked Trump to reconsider, saying his presence could stoke more violence in the city.Blake was shot during an altercation with police on Aug. 23. Police say they were responding to a call about a man at a party who "shouldn't have been there."Police attempted to take Blake into custody but say he was non-compliant. Officers say they tried to use stun guns on Blake but could still not take him into custody.Blake had previously told officers he had a knife in his vehicle. At one point during the altercation, as Blake approached his car, Officer Rusten Sheskey shot Blake in the back at least seven times. A knife was later found on the floorboard of the car.Blake is still hospitalized and is paralyzed from the waist down. Sheskey has been placed on administrative leave but has not been charged with a crime. 2020

The divisive presidential election found students at Westminster High School in Maryland split over a controversial poster that some saw as a symbol of hope. Others viewed it as a knock on Donald Trump. But other symbols like the Confederate flag also sparked unrest at the school."Actually, we had a bunch of people having flags connected to their trucks.  People wearing it all the time,” said Jakob Hill, a 2017 graduate, “It was actually surprising to see it, but it was in the schools. I have a bunch of friends that are still in Westminster and they still see it."But starting today, they won't see it anymore.Superintendent of Schools Stephen Guthrie says both the rebel flag and the Nazi swastika are now banned anywhere on school property."While we were getting complaints from students who were not only offended. It goes much deeper than offense,” Guthrie said. “They really were losing the ability to do their work. This represented hatred to them. They thought it advocated violence. So we went through a process with our attorneys and legally to determine if we could make decisions that would limit that dress."Guthrie points to the move to remove Confederate statues from public lands and the rally that turned deadly in Virginia as evidence the change was needed."We have the Charlottesville issue with the swastika and the Confederate battle flag were side by side with acts of violence and hatred and intolerance, and so we saw this change happening around us," Guthrie said.It is a bid to prevent symbols of hate that can lead to violence."You never know who you're going to offend and it's just safe if you try not to wear them," Melanie Morel of Westminster said.Violence has already erupted among students inside the schools when symbols divide them."We had a couple of fights last year about it actually,” said Hill, “People using racist terms and all that and people taking it under a different context."The superintendent says when students violate the dress code his hope is to make it a teachable moment, rather than a punitive one, in hopes of bringing students closer together. 2160

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