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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 clock is ticking for restaurants across the country that are starving for cash and desperate for another round of aid from the federal government, as an estimated 16,000 restaurants have already closed since the COVID-19 outbreak began.For Kari Kuelzer, who owns Grendel's restaurant in Cambridge, Massachusetts, the burden of keeping her small business open in particularly heavy. This dive bar located just blocks away from Harvard University was first opened by her parents in 1971 and has been a fixture for both students, locals and tourists who visit the area.But without another round of federal aid, Kuelzer is uncertain what the future of Grendel's looks like."The dominoes are going to fall. Without some kind of support, some kind of stimulus, all facets of the economy are going to struggle and it’s needless," she said while standing in the kitchen of Grendel's.Like restaurant owners around the country, this 50-year-old business owner has tried to get creative, from outdoor screened-in pods for dining to a new line of to-go cocktails and trail mix. Kuelzer knows, though, mixed drinks aren’t going to keep her afloat forever."We need more forgivable loans," she said.Politicians in Washington are at a stalemate over another round of funding, something especially troubling to Kuelzer, who saw an immediate impact from those first round of stimulus checks."The moment people started getting their unemployment stimulus checks, we saw an uptick in business,” she recalled. “The minute it went away, we saw it fall down.”Sean Kennedy with the National Restaurant Association says Congress needs to step in to help the nation's restaurants that employ nearly 15.6 million people across the country."The restaurant industry is in a unique challenge. We were the first to shut down and we’ll be the last to recover,” Kennedy said. “What’s clear is we need a more long-term, far-reaching approach from the federal government or restaurants are going to survive.”Historically, restaurants have the lowest amount of cash on hand compared to any industry in the country. Most restaurants only have enough cash to get by for 16 days, and nationwide, more than 100,000 restaurants have had to shut down for a second time."We’ve lost more jobs and more revenue than any of industry. That needs to be an alarm bell," Kennedy said.As for restaurant owners like Kuelzer, she'll keep trying to reinvent a recipe for survival, knowing her family's legacy is on the line."We really will need to have some assurances; we’ll get some government assistance," she said. 2576

The COVID-19 pandemic has ensured that holiday gatherings will look a lot different for many this year, and for some parents, it might be difficult to explain why to their children.Children's mental health experts at Children's Hospital Colorado say parents need to be direct with kids about the importance of keeping loved ones safe and healthy.Dr. Jenna Glover says that encouraging kids to share their ideas for family gatherings could help them accept the changes. She adds that parents should also emphasize that smaller gatherings are still worth celebrating."(Parents should) really have their kids focus on what they can control and what is still available to them, rather than on a deficit and what they don't have," Dr. Glover said. "So shifting the perspective to, 'this is what we're grateful for having,' rather than, 'this is why we're sad.'"Doctors say it's important to recognize when children are having a hard time accepting smaller gatherings or missing family members. Children may change how they interact with others or express increased irritability or a desire to be alone. Parents might also notice changes in eating or sleeping habits.Experts say that if behavioral changes get serious enough, parents might want to consider professional help for their kids. And with a rise in telemedicine, getting help is a little easier."If a kid can Zoom in with somebody from their bedroom, laying on their bed flopped over, they might feel a lot more comfortable," Dr. Glover said. "That really informal setting, of being in their own space and being able to connect with somebody and share thoughts that maybe they're not willing to talk about with their parents right now."Dr. Glover says parents should be prepared for their kids to compare how their family celebrates with how their friends are celebrating the holidays. She says it's important to empathize with their children and acknowledge their concerns — but adds that parents should remind kids that the pandemic won't go on forever. 2018

The FBI says a British socialite who was accused by many women of helping procure underage sex partners for Jeffrey Epstein has been arrested in Bradford, New Hampshire.The FBI said Thursday that Ghislaine Maxwell was taken into custody at around 8:30 a.m. on charges related to the Epstein scandal.Epstein killed himself in a federal detention center in New York last summer while awaiting trial on sex trafficking charges.Maxwell was accused by many women of recruiting them to give Epstein massages, during which they were pressured into sex. She's been charged with four counts relating to sex trafficking and two counts of perjury.During a press conference Thursday, Acting Attorney for the Southern District of New York Audrey Strauss thanked the victims who came forward to authorities. She said that without their help, they would not be able to charge Maxwell.Strauss also urged Prince Andrew to speak with investigators and cooperate with the ongoing investigations into Epstein and Maxwell. The British royal was known to be friendly with Epstein during the time abuse occurred and has described their relationship as a friendship. He even stayed at Epstein's New York apartment in 2010, two years after Epstein was convicted of sex crimes.Maxwell has repeatedly denied wrongdoing and called some of the claims against her "absolute rubbish." 1361

The FDA is offering formal guidance on the amount of inorganic arsenic allowed in infant rice cereal.Exposure to inorganic arsenic has been associated with neurodevelopmental effects, according to the Food and Drug Administration, including lung and bladder cancer risk. Arsenic occurs naturally in the soil, and rice has been shown to absorb a small amount during the growing process.The new guidance identifies a level of at or below 100 micrograms per kilogram and is based on draft guidance from 2016. The guidance is recommended, but not legally enforceable.“It is important to note that the agency’s data show that most products on the market are already below this level and that parents and caregivers should know that a well-balanced diet also includes a variety of grains like oats and barley,” said a statement from Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.According to the FDA, results from testing in 2018 showed 76 percent of samples were at or below the 100 ppb level, compared to 47 percent of samples tested in 2014 and 36 percent of samples tested between 2011-2013.The FDA attributes the drop in inorganic arsenic presence to changes manufacturers are making in sourcing rice and testing their ingredients. 1279

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