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The FBI raid on President Donald Trump's personal attorney Michael Cohen sought information that included payments allegedly made to keep women silent about affairs with Trump more than a decade ago.A source familiar with the matter told CNN Tuesday that a focus of the raid was to seek records on the deal set up between ex-Playboy Playmate Karen McDougal and a company that reportedly paid her amid the 2016 presidential campaign cycle to keep her account from publication. 483
The Church of Jesus Christ of Latter-day Saints is embarking on a rebranding effort of sorts.The church, commonly referred to as the Mormons, really wants people to stop using that word. It also wants people to stop using LDS as an abbreviation. From now on, it prefers that people use the church's full name, and when a shortened reference is needed, to just use "the Church" or "Church of Jesus Christ."These preferences are contained in a new style guide that the Church of Jesus Christ of Latter-day Saints released Thursday. It states that while "the term 'Mormon Church' has long been publicly applied to the Church as a nickname, it is not an authorized title, and the Church discourages its use." It also asks that the term "Mormons" not be used in references to members.Also out: the word "Mormonism," which the style guide states is an "inaccurate" word to use to describe the "doctrine, culture and lifestyle unique to The Church of Jesus Christ of Latter-day Saints." But the word Mormon is fine to use in proper names, like the Book of Mormon, or in historical expressions like the Mormon Trail. 1126
The estimated jackpot for the next Powerball drawing is 5 million after Wednesday's drawing provided no winners.The cash value is 9.4 million and the next drawing takes place Saturday, March 17, which is also St. Patrick's Day.Click here to visit the Powerball website. 283
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 Department of Defense announced on Friday the formation of the Unidentified Aerial Phenomena Task Force, which will be tasked with looking into reports of UFOs.The Pentagon says that task force’s mission is to detect, analyze and catalog unidentified aerial phenomena, better known as UFOs, that could potentially pose a threat to U.S. national security.“As DOD has stated previously, the safety of our personnel and the security of our operations are of paramount concern,” the Department of Defense said. “The Department of Defense and the military departments take any incursions by unauthorized aircraft into our training ranges or designated airspace very seriously and examine each report. This includes examinations of incursions that are initially reported as UAP when the observer cannot immediately identify what he or she is observing.”Sen. Marco Rubio confirmed the formation of the task force last month in an interview with Miami’s WFOR-TV."We have things flying over our military bases and places where we are conducting military exercises, and we don't know what it is and it isn't ours, so that's a legitimate question to ask,"Rubio said.In April, the Pentagon released videos of “unidentified aerial phenomena” captured by Navy pilots. One of the videos was from 2004, while another two were from 2015.“After a thorough review, the department has determined that the authorized release of these unclassified videos does not reveal any sensitive capabilities or systems, and does not impinge on any subsequent investigations of military air space incursions by unidentified aerial phenomena,” the Pentagon said in April. “DOD is releasing the videos in order to clear up any misconceptions by the public on whether or not the footage that has been circulating was real, or whether or not there is more to the videos.” 1846