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The first wife of the Texas church shooter described him as a menacing and abusive man who constantly threatened her and her family with death.Devin Patrick Kelley carried out the deadliest mass shooting in Texas history on Sunday, killing 25 people and an unborn child at First Baptist Church in Sutherland Springs, near San Antonio.In an interview Friday with the TV show "Inside Edition," Kelley's ex-wife, Tessa Brennaman, 25, said her life was filled with abuse when she was married to him. 508

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 cold open of "Saturday Night Live" usually belongs to politics, but on Saturday night it belonged to moms.The mothers of cast members from the NBC variety show took over the beginning of Saturday's episode with many taking jabs at the show's political jokes.Kenan Thompson asked his mother if she liked the show and she responded, "I do, except for all the political stuff. We get it!"Mikey Day introduced his mother and reminded her of the time he was in a production of "The Crucible" in high school."You know, 'The Crucible' is a lot like that witch hunt against President Trump," Day's mother said before Day quickly ushered her off.The mother of the newcomer Luke Null asked, "Why doesn't 'SNL' talk about 'Crooked Hillary'?""Mom, I'm so new here," he said. "Please don't do this to me."As for Chris Redd's mother, she wondered why everyone is focused on Trump rather than "focusing on Jesus.""Okay, well, Jesus isn't president," Redd said."And that's the problem," his mother said back.And "Weekend Update" host Colin Jost asked his mom if she likes the political stuff on the show."I think Alec Baldwin does a great Trump impression," she said. "But why does it have to be so mean? Who writes that stuff?"Jost, who is also one of the show's head writers, hesitated and responded saying he didn't know blaming his "Weekend Update" co-host, Michael Che, who is also a head writer, for the jokes. 1412

The FBI seized recordings President Donald Trump's attorney made of his conversations with a lawyer representing two women who had alleged affairs with Trump, a source familiar with the matter tells CNN.The recordings could prove valuable to the government's criminal investigation of Michael Cohen. The President's personal attorney is under scrutiny in part for his role in seeking to suppress the alleged affair through a hush deal with porn star Stormy Daniels. The warrant sought information about that payment along with any information that connected Cohen with efforts to suppress disclosure of Trump's alleged affair with Playboy model Karen McDougal.The warrant for the raids also specified that Cohen was being investigated for bank fraud, wire fraud and campaign finance issues, CNN reported earlier this week.While Cohen has admitted to no wrongdoing, the intensity of the government's investigation will put significant pressure on one of the President's closest confidants. If Cohen chooses to cooperate rather than fight a potential case against him, then his knowledge about the President's activities could create serious problems for Trump as special counsel Robert Mueller continues his investigation.The source said Cohen recorded some calls he had with attorney Keith Davidson, who at the time represented both Daniels and McDougal. Davidson no longer represents either woman. Their deals to keep their stories about alleged affairs quiet are now the subject of litigation, with each seeking to be released from their agreements.Another source tells CNN that in at least one conversation between the two men, "Cohen was being unusually simplistic, like he had bullet points that he was reading from to try and make himself look good. He was trying to clarify the timeline of the agreements made with Davidson in his (Cohen's) favor.""Attorney Davidson never consented to any recordings of his conversations with Mr. Cohen. If they in fact do exist, Attorney Davidson will pursue all his legal rights under the law," Dave Wedge, a spokesman for Davidson, said. Recording phone conversations without the consent of both parties could be a legal issue if Davidson was in a state that has such laws, like California.Cohen's attorney and a spokesman for Cohen's attorney did not reply to requests for comment.Prosecutors are "going to be very excited at the prospect of having an independent means of corroborating what was said between the two parties," CNN legal analyst and former federal prosecutor Michael Zeldin said. "If all that stuff gets recorded, then they are in deep hurt because if it was just oral between them, it could be a conspiracy of liars but the tapes undermine that."Zeldin said a conversation between attorneys for different clients would most likely not be considered covered by attorney-client privilege.McDougal alleges in a lawsuit that Cohen has a cozy relationship with Davidson. She argues Davidson was part of a "broad effort to silence and intimidate her and others." Davidson denies that claim.In an exclusive interview with CNN last month, Davidson described several calls he had with Cohen about striking a deal for Daniels to keep her story quiet.Davidson also said he was contacted in recent weeks by Cohen, who encouraged him to go out and reveal what he knew about his clients and their agreements. Davidson said Cohen argued that the women had waived attorney-client privilege by going public with their stories."He suggested that it would be appropriate for me to go out into the media and spill my guts," Davidson said.There was no discussion of recordings during a court hearing on Friday to argue over Cohen's filing of a temporary restraining order that seeks to suppress the evidence gathered in the raid.The Davidson recordings may not be the only conversations the FBI gathered in the raid. Cohen often recorded telephone conversations both before and during the 2016 presidential campaign that also could have been scooped up in the FBI raid on his apartment, office and hotel room, sources told CNN.One source said Cohen played to Trump and some associates conversations that he had with political and media figures during the exploratory part of the campaign.The-CNN-Wire 4249

The Democratic National Convention gets underway this week. Republicans will hold their convention next week. While this year's convention is virtual for both parties, have you asked yourself what's the point of these anyway?CONVENTIONS YEARS AGO WERE DIFFERENT Americans have known for months that Joe Biden is going to be the Democratic nominee and that Donald Trump would be the Republican nominee. However, before political parties started relying on primaries, conventions were the place the nominee was decided.In 1856, it took Abraham Lincoln three rounds of voting to become the Republican nominee. In 1924, Democrats needed 103 ballots over 16 days to pick John Davis as their party nominee.CONVENTIONS PURPOSE In 1948, networks began televising conventions and since then, many argue conventions have become taxpayer-funded spectacles for insiders. While taxpayers are no longer directly funding conventions, they are paying for security. In 2016, it was estimated that around 0 million of taxpayer funds were spent on convention security. 1952 was the last year both political parties had a contested convention; however, party insiders believe conventions still play a pivotal role. Conventions are where networking can take place and where delegates can debate the party platform. It's also a place where training sessions can occur and speeches can take place. Could Barack Obama have become president in 2008 without his speech at the 2004 convention? Sure, it's possible, but that speech was credited with making the Illinois state senator a household name. WILL 2020 CHANGE CONVENTIONS? With the events now online, after these next two weeks, both parties will likely sit down and see if in-person conventions need to be changed at all. Do parties need a full week of expensive arena space? Or would that money be better spent on staffing in swing states? Will Americans tune in like they did in 2016 this year? These are just some of the questions that will be asked following the conventions. 2023