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The European leg of Lady Gaga's "Joanne World Tour" has been postponed as the singer grapples with health issues, Live Nation announced Monday.In a statement posted on the promoter's site,?Live Nation revealed that the portion of the tour that was set to begin September 21 in Barcelona, Spain, and conclude on October 28 in Cologne, Germany, has been postponed until 2018."Lady Gaga is suffering from severe physical pain that has impacted her ability to perform," the statement read. "She remains under the care of expert medical professionals who recommended the postponement earlier today." 602
The Country Music Association on Friday reversed its decision to ban reporters from asking questions about the Las Vegas mass shooting during its upcoming awards show.The CMA faced criticism after it sent out media guidelines for its "51st Annual CMA Awards" which will be held Wednesday, November 8 at Bridgestone Arena in Nashville, Tennessee, and broadcast live on ABC.The guidelines asked journalists to avoid discussing several politically charged topics, including the mass shooting at the Route 91 Harvest Festival in Las Vegas last month, which left 58 people dead and more than 500 injured."In light of recent events, and out of respect for the artists directly or indirectly involved, please refrain from focusing your coverage of the CMA Awards Red Carpet and Backstage Media Center on the Las Vegas tragedy, gun rights, political affiliations or topics of the like," a section of the guidelines read. "It's vital, more so this year than in year's past due to the sensitivities at hand, that the CMA Awards be a celebration of Country Music and the artists that make this genre so great."But on Friday, the organization reversed that edict."CMA apologizes for the recently distributed restrictions in the CMA Awards media guidelines, which have since been lifted," it said in a statement to CNNMoney. "The sentiment was not to infringe and was created with the best of intentions to honor and celebrate Country Music."The CMA Awards draw some of the music genres' biggest names and for the tenth straight year, it will be hosted by country superstars Carrie Underwood and Brad Paisley.The original guidelines included a warning to those who don't heed them, including potentially missing out on covering country music's premiere event."It's an evening to honor the outstanding achievements in Country Music of the previous year and we want everyone to feel comfortable talking to press about this exciting time," the guidelines state. "If you are reported as straying from these guidelines, your credential will be reviewed and potentially revoked via security escort."The tragedy has stirred a great deal of discussion in the country music community among fans and performers alike, given the genre's association with gun culture.Gun control debate enters country music community: 'Is this the kind of world we want to live in?'Paisley told Rolling Stone last month that he feels the pressure of handling the tragedy correctly while hosting the awards show."We're not going to ignore it, but we're not going to also dwell on that," he said.. "We have to make sure we honor those we've lost, but we also [have to] celebrate this music, which lives on, and do a good job having the heart we need to have on that night. And also the theme of the show this year is very much about unity and coming together as a format."Friday morning, the singer had slammed the ban in a tweet that urged the CMA to reverse the guidelines."I'm sure the CMA will do the right thing and rescind these ridiculous and unfair press guidelines," he wrote. "In 3...2....1....." 3070
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 first hearing in CNN and Jim Acosta's federal lawsuit against President Trump and several top White House aides lasted for two hours of tough questioning of both sides.At the conclusion of the hearing, Judge Timothy J. Kelly said he would announce his decision Thursday afternoon.CNN and Acosta are alleging that the White House's suspension of his press pass violates the First and Fifth Amendments.The hearing started around 3:40 p.m., Kelly began by probing CNN's arguments for the better part of an hour. Then he turned to questioning a lawyer representing the government.Lawyers for the network and Acosta asked for a temporary restraining order and a preliminary injunction that would restore his press pass right away, arguing that time is of the essence because his rights are violated every day his pass is suspended.Kelly opened the hearing by quizzing CNN attorney Theodore Boutrous on the network's First Amendment claim and asking how the President's history of attacks on CNN should be viewed in the context of the lawsuit.Boutrous rattled off examples of Trump's missives against CNN, including his claim that the network is an "enemy of the people."Kelly expressed skepticism that this proves the Acosta ban is "content-based discrimination," as CNN is alleging.Kelly said there is some evidence that Acosta's conduct -- not his content -- led the White House to suspend his press pass.But Boutrous disputed that and said there "never will there be more evidence of facial discrimination and animus against an individual reporter" than in this case.Kelly said "we've all seen the clip" of the White House press conference where Trump and Acosta had a combative exchange last week. Kelly said that Acosta "continued speaking after his time expired" and "wouldn't give up his microphone" -- points that the Trump administration made in its briefs earlier Wednesday.Under questioning from the judge, Boutrous cited Trump's words to Acosta from the press conference, and said, "'Rudeness' is really a code word for 'I don't like you being an aggressive reporter.'"Kelly peppered CNN's attorney with hypotheticals as he tried to determine what a lawful move by the White House, responding to Acosta's actions, would look like."Could they let him keep the pass but tell him he couldn't come to presidential press conferences?" Kelly asked.Boutrous contended that even a partial response like that would be a violation of Acosta's First Amendment rights.Boutrous called the White House's move to revoke Acosta's hard pass "the definition of arbitrariness and capriciousness.""What are the standards?" Boutrous asked. "Rudeness is not a standard. If it were no one could have gone to the press conference."Boutrous separately brought up evidence that hadn't been available when CNN filed its suit: A fundraising email that the Trump campaign sent Wednesday.The email touted the decision to revoke Acosta's credentials and attacked CNN for what it called its "liberal bias." Boutrous said that by grouping that all together in the same breath, the email made it clear that it was Acosta's coverage and not his conduct at a press conference that triggered the revocation of his press pass.Kelly asked CNN's lawyers to state the company's position regarding the original White House accusation that Acosta placed his hands a White House intern as she tried to grab his microphone away."It's absolutely false," Boutrous said.Boutrous also pointed out that Trump administration never mentioned that accusation against Acosta in the 28-page brief that Justice Department lawyers filed with the court earlier on Wednesday."They've abandoned that" claim, Boutrous said.In his first question in a back and forth with the government, Kelly asked Justice Department attorney James Burnham to clear up the government's shifting rationale for revoking Acosta's pass."Why don't you set me straight," Kelly said. "Let me know what was the reason and address this issue of whether the government's reason has changed over time.""There doesn't need to be a reason because there's no First Amendment protection and the President has broad discretion," Burnham said.Still, Burnham called the White House's stated reasonings "pretty consistent throughout," and walked through a series of statements that the administration has made — from Trump's first comments at the press conference to Sanders' tweets announcing the revocation to the official statement put out Tuesday after CNN filed its suit.Burnham said Sanders' claim that Acosta had inappropriately touched a White House intern was not a part of their legal argument."We're not relying on that here and I don't think the White House is relying on that here," Burnham said.Burnham said that it would be perfectly legal for the White House to revoke a journalist's credentials if it didn't agree with their reporting.He made the assertion under questioning from Kelly, who asked him to state the administration's position in this hypothetical situation.The judge asked if the White House could essentially tell any individual journalist, "we don't like your reporting, so we're pulling your hard pass." Burnham replied, "as a matter of law... yes."Pressed again by the judge on Sanders' claim that Acosta had inappropriately touched the intern, Burnham said "we don't have a position" on that."The one consistent explanation," Burnham said, "is disorder at the press conference."Burnham contended that revoking Acosta's hard pass was not "viewpoint discrimination" — part of a legal threshold for a First Amendment claim."A single journalist's attempt to monopolize a press conference is not a viewpoint and revoking a hard pass in response to that is not viewpoint discrimination," Burnham said.Kelly tried to press for details about how Acosta's pass came to be revoked, asking Burnham who made the actual decision.Burnham said he didn't have any information beyond what had been filed in court documents: that the revocation was first announced by Sanders on November 7 and then "ratified" by Trump the next day."Do you have any information to suggest that it was anyone other than Ms. Sanders that made the decision?" Kelly asked."No, not that I'm offering today. I'm not denying it but I don't know anything beyond what's been filed," Burnham said.Later, Burnham argued that revoking Acosta's press pass does not infringe on his First Amendment rights because he can still call White House staffers for interviews or "catch them on their way out" of the building."I think the harm to the network is very small," Burnham said."Their cameras are still in there," he added.Burnham said CNN had made an "odd First Amendment injury" claim and suggested that Acosta could do his job "just as effectively" watching the President's appearances piped into a studio on CNN."The President never has to speak to Mr. Acosta again," Burnham said. "The President never has to give an interview to Mr. Acosta. And the President never has to call on Mr. Acosta at a press conference.""To be in a room where he has no right to speak... this seems to me like an odd First Amendment injury that we're talking about," Burnham said.Boutrous, the CNN attorney, fired back on rebuttal."That's not how reporters break stories. It's simply a fundamental misconception of journalism," Boutrous said, adding how unscheduled gaggles and source meetings throughout the White House amounted to "invaluable access."In a legal filing by the Justice Department on Wednesday, the White House asserted that it has "broad discretion" to pick and choose which journalists are given a permanent pass to cover it.That position is a sharp break with decades of tradition. Historically both Republican and Democratic administrations have had a permissive approach to press access, providing credentials both to big news organizations like CNN and obscure and fringe outlets.Acosta's suspension -— which took effect one week ago — is an unprecedented step. Journalism advocates say it could have a chilling effect on news coverage.CNN and Acosta's lawsuit was filed on Tuesday morning, nearly one week after Acosta was banned.Before the hearing began, CNN's lawyers said the case hinges on Acosta and CNN's First Amendment rights; the shifting rationales behind the ban; and the administration's failure to follow the federal regulations that pertain to press passes, an alleged violation of Fifth Amendment rights. The lawsuit asserts that this ban is really about Trump's dislike of Acosta.The "reasonable inference from defendants' conduct is that they have revoked Acosta's credentials as a form of content- and viewpoint-based discrimination and in retaliation for plaintiffs' exercise of protected First Amendment activity," CNN's lawsuit alleges.In addition to the temporary restraining order and preliminary injunction that CNN is seeking at the hearing, CNN and Acosta are also seeking what's known as "permanent relief." The lawsuit asks the judge to determine that Trump's action was "unconstitutional, in violation of the First Amendment and the Due Process Clause of the Fifth Amendment." This could protect other reporters against similar actions in the future."If the press is not free to cover the news because its reporter is unjustly denied access, it is not free," former White House correspondent Sam Donaldson said in a declaration supporting CNN that was filed with the court on Tuesday. "And if denying access to a reporter an organization has chosen to represent it -- in effect asserting the president's right to take that choice away from a news organization and make it himself -- is permitted, then the press is not free."Ted Olson, a Republican heavyweight who successfully argued for George W. Bush in Bush v. Gore, is representing CNN, along with Boutrous — himself another prominent attorney — and the network's chief counsel, David Vigilante.Olson said Tuesday that while it was Acosta whose press pass was suspended this time, "this could happen to any journalist by any politician."He spoke forcefully against Trump's action. "The White House cannot get away with this," Olson said.Most of the country's major news organizations have sided with CNN through statements and plan to file friend-of-the-court briefs. 10291
The FBI said on Tuesday that cybercriminals and foreign actors are attempting to influence the upcoming election.According to the FBI, “Foreign actors and cybercriminals could create new websites, change existing websites, and create or share corresponding social media content to spread false information in an attempt to discredit the electoral process and undermine confidence in U.S. democratic institutions.”Beyond attempts to influence the vote, the FBI says these actors are attempting to sow distrust in the electoral system. The FBI in particular warns that cybercriminals could take advantage of the likelihood several states will need additional time to count ballots due to increased mail-in voting and social distancing protocols. While a delay in results does not indicate any wrongdoing, the FBI warns that foreign actors could attempt to spread misinformation to cause distrust in the system while votes are being tallied.Last month, the Office of the Director of National Intelligence released a statement outlining efforts by Iran, China and Russia to attempt to undermine this year’s presidential election.“Ahead of the 2020 U.S. elections, foreign states will continue to use covert and overt influence measures in their attempts to sway U.S. voters’ preferences and perspectives, shift U.S. policies, increase discord in the United States, and undermine the American people’s confidence in our democratic process,” William Evanina, director of the United States National Counterintelligence and Security Center, said. "They may also seek to compromise our election infrastructure for a range of possible purposes, such as interfering with the voting process, stealing sensitive data, or calling into question the validity of the election results. However, it would be difficult for our adversaries to interfere with or manipulate voting results at scale.”As part of Evanina’s assessment, he said that China and Iran were attempting to seek a favorable outcome for Biden, while Russia was working to ensure a favorable outcome for Trump.“As Americans, we are all in this together; our elections should be our own,” Evanina previously said. “Foreign efforts to influence or interfere with our elections are a direct threat to the fabric of our democracy. Neutralizing these threats requires not just a whole-of-government approach, but a whole-of-nation effort.”The FBI offered the following recommendations to voters:Seek out information from trustworthy sources, such as state and local election officials; verify who produced the content; and consider their intent.Verify through multiple reliable sources any reports about problems in voting or election results, and consider searching for other reliable sources before sharing such information via social media or other avenues.For information about final election results, rely on state and local government election officials.Report potential election crimes—such as disinformation about the manner, time, or place of voting—to the FBI.If appropriate, make use of in-platform tools offered by social media companies for reporting suspicious posts that appear to be spreading false or inconsistent information about election-related problems or results. 3236