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The fatal shooting of two black people in a Kroger grocery store in Kentucky is being investigated as a hate crime, Jeffersontown Mayor Bill Dieruf told CNN on Monday.Gregory A. Bush, a white 51-year-old, is accused of killing Maurice Stallard, 69, and Vickie Jones, 67, last Wednesday inside the Jeffersontown grocery store and in the parking lot, respectively.Prior to the shooting, Bush allegedly tried to enter a predominantly black church nearby but was unable to get inside, officials said. When that attempt failed, he went to Kroger instead and opened fire in the store. 586

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 Democratic National Committee chairman assured supporters Thursday that a scaled-down convention would go on as scheduled in August in Milwaukee, Wisconsin."From the very beginning of this pandemic, Democrats have put the health and safety of the American people first. Unlike Trump, we followed the science, listened to doctors and public health experts, and worked through plans to protect lives," DNC Chairman Tom Perez said in a series of tweets. "That's how we made the decision to hold a responsible convention that will bring our country together, ensure our delegates can take care of official business without risk to public health, and still shine a spotlight on our host community of Milwaukee."In June, DNC leaders announced plans to transform the convention amid the pandemic, moving it from the Fiserv Forum, a 17,000-seat arena, to Wisconsin Center, a convention center. The DNC also advised state delegates to not travel to Milwaukee.Presumptive Democratic nominee Joe Biden still plans to accept the nomination in Milwaukee. The DNC is slated to begin Aug. 17. 1089

The daughter of a former Russian spy who was poisoned alongside her father in Britain last month has been discharged from the hospital, an official from the hospital said Tuesday.Yulia Skripal and her father Sergei Skripal were found slumped on a bench on March 4 in the English city of Salisbury after being exposed to a military-grade nerve agent, British authorities said.The UK government blamed Russia for the attack, but Moscow has denied any involvement.Yulia Skripal regained consciousness in late March and released a statement last week thanking those who treated her and father and those who had sent "messages of goodwill.""Yulia has asked for privacy from the media and I want to reiterate that request," Salisbury District Hospital medical director Christine Blanshard said Tuesday. "I also want to take this opportunity to wish Yulia well. This is not the end of her treatment, but marks a significant milestone."Blanshard added that Sergei Skripal's condition was still improving, albeit at a slower pace than Yulia."Her father has also made good progress," Blanshard said. "On Friday, I announced that he was no longer in a critical condition. Although he is recovering more slowly than Yulia, we hope that he too will be able to leave hospital in due course."London's Metropolitan Police refused to comment on whether Yulia Skripal was receiving police protection following her release from the hospital.In a tweet, the Russian embassy in the UK said: "We congratulate Yulia Skripal on her recovery. Yet we need urgent proof that what is being done to her is done on her own free will."  1618

The Department of Justice has issued a clarification after some social media users spread disinformation about the use of masks amid the coronavirus pandemic.As cases of COVID-19 spike throughout the country, several states, counties and cities have issued mandates requiring masks in public — and local media reports from across the country indicate that Facebook users in those areas may have seen a viral post containing inaccurate information.While regulations differ from state to state and city to city, many local governments have determined those with pre-existing conditions that would make wearing a mask difficult are exempt from the ordinances. But some viral Facebook posts indicate that the Department of Justice has required exemption cards for those who cannot wear masks.Many of the viral posts contain a screenshot of the "card," containing the Department of Justice seal and a reference to the "Freedom to Breathe Agency.""The Department of Justice has been made aware of postings or flyers on the internet regarding the Americans with Disabilities Act (ADA) and the use of face masks due to the COVID-19 pandemic, many of which include the Department of Justice's seal. These postings were not issued by the Department and are not endorsed by the Department," the DOJ said on its website.The Freedom To Breathe Agency refers to a private Facebook group opposed to government restrictions related to COVID-19 with about 7,000 members. A website listed on the "card" for the agency is not currently active.The Department of Justice recommends visiting Americans with Disabilities Act website for the latest updates from the department. 1661