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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 Centers for Disease Control and Prevention released a report today that says fentanyl has become the deadliest drug in the nation, overtaking heroin.From 1999 to 2016, drug overdose deaths in the United States tripled from 6.1 per 100,000 people to 19.8 per 100,000 people, the CDC report says. The study examined decedents who were U.S. residents with an underlying cause of death being a drug overdose, including people who did it unintentionally and intentionally (suicide and homicide and undetermined reasons)."The top 10 drugs involved in overdose deaths remained consistent throughout the 6-year period, 622

The death toll in a series of wildfires in California, Oregon and Washington rose to 36 as officials warn that an already-historic fire season is "far from over."As of Tuesday morning, wildfires have killed 25 people in California, 10 people in Oregon and one person in Washington dating back to mid-August.Fifteen people alone have died in California's North Complex Fire, which is currently burning in the Sierra Nevada mountains north of Sacramento. According to Cal Fire, the fire which has been burning for nearly a month, is currently 39% contained.In Oregon, the Beachie Creek fire and the Alameda Fire have each killed four people in recent days. The Beachie Creek fire, currently burning in the northern part of the state since Aug. 16, is 15% contained. The Alameda Fire is 100% contained, according to the Oregon wildfire dashboard.Though 2020 has already marked a record-setting year for wildfires in the western U.S., officials are bracing for more damage in the coming weeks. Wildfire season typically lasts through the end of October on the West Coast."We've had major destruction and, even sadly, two dozen fatalities already and we still have several months to go in our fire season here. Unfortunately, this record-setting year is far from over," Cal Fire spokesperson Daniel Berlant told Fox News on Monday night.The wildfires garnered the focus of both President Donald Trump and his political rival, Democratic presidential nominee Joe Biden on Monday. After receiving a briefing from officials in California, Trump placed the blame for the fires on "forest management," and seemed to downplay the effect of climate change during a conversation with California Gov. Gavin Newsome. In a speech from Delaware, Biden promised to address climate change should be elected president, and slammed Trump for ignoring the facts on the changing climate. 1872

The FBI's top liaison on Capitol Hill is out.Greg Brower, an FBI assistant director and head of the Office of Congressional Affairs, stepped down last Friday after a year on the job. In the role, Brower was on the receiving end of a pack of congressional probes into the law enforcement agency's conduct.The decision, a "tough" one he made of his own accord, Brower said, follows other high-level departures from the bureau as FBI Director Christopher Wray assembles his own team of close advisers."It was tough but I had an offer I couldn't refuse from a great law firm," Brower said in an interview Thursday. "It was very gratifying to be a part of that team. I could not be more proud of how people work and how committed they are to the mission."Brower was appointed to the position by then-FBI director James Comey in March of 2017 after serving as the bureau's deputy general counsel. He will join the lobbying and law firm Brownstein Hyatt Farber Schreck as a shareholder in the litigation department.The work in the legislative affairs office has heated up during Brower's tenure, as the fallout from Comey's firing by President Donald Trump has fanned a growing mistrust of the FBI among some lawmakers and spurred a round of congressional investigations.Not long before Brower's departure, the chairman of the House Judiciary Committee slapped the Justice Department with a subpoena for documents related to a trio of recent controversial decisions made by the FBI, including the move in 2016 to not charge Hillary Clinton after the probe of her email server and the internal recommendation by an FBI office to fire former FBI Deputy Director Andrew McCabe.In response, Wray said last week that the pace of document production for congressional inquiries at the bureau was "too slow" and doubled the number of FBI staff responsible for reviewing the records.On Thursday, Brower said he had worked with the FBI's Office of the General Counsel, which reviews the internal documents for release, before his departure to get a "a better plan in place" to respond to "an unprecedented wave of oversight requests.""That's all really on track," Brower said, adding that his decision to leave had nothing to do with the probes. "As the director mentioned, it's probably taking longer than it should, but the volume is just so unprecedented that we finally had to put more people on it."Brower's year atop the office saw big wins for the bureau on Capitol Hill, including a six-year extension of the controversial foreign surveillance program known as FISA Section 702 in January and the recent passage of the CLOUD Act, which makes it easier for the US to collect data stored overseas."I felt like the biggest things I set off to do in '17 were done and I felt less bad about leaving," he said.Brower is the fifth top adviser to the director to leave his position since Trump tapped Wray to replace Comey in June. 2943

The government of Puerto Rico has quietly admitted that the death toll from Hurricane Maria -- a subject of great controversy -- may be far higher than its official estimate of 64.In a report to Congress dated Wednesday, the US commonwealth's government says documents show that 1,427 more deaths occurred in the four months after the storm than "normal," compared with deaths that occurred the previous four years.The 1,427 figure also appeared in a draft of the report -- "Transformation and Innovation in the Wake of Devastation" -- which was published and opened for public comment July 9. The figure was first "revealed" by the Puerto Rico government, according to the final report, on June 13, one day after officials were forced by a judge to release death records that CNN and the Centro de Periodismo Investigativo in Puerto Rico had sued to make public.Officials stopped short of updating the official death toll for the September 20 storm."The official number is being reviewed as part of a study under way by George Washington University," the report says. Officials hired that university to review the toll after news reports, including those from CNN, called it into question.The George Washington University study "will have certainty" about the number of people the government believes died in Hurricane Maria and its aftermath, Pedro Cerame, a spokesman for the Puerto Rican government in Washington, told CNN. Officials initially said that report would be released in May. Now they expect it to publish this month."We understand that the number is higher," Carlos Mercader, executive director of the Puerto Rico Federal Affairs Administration, told CNN in an interview. "We didn't commission the study to prove there were 64 (deaths). We wanted a scientific and epidemiological study that would give us light, not only on the number -- we know the number is higher -- but the reasons why this happened."The 1,427 figure is "an estimate," Cerame said, and it may include deaths that weren't related to the storm.It's an estimate that follows many others like it.In November, CNN surveyed 112 funeral homes -- about half the total -- across the island, finding that funeral home directors and staff had identified at least 499 deaths they believed to be related to Hurricane Maria and its chaotic aftermath, which included months without power for many of the island's 3.3 million residents. In December, the New York Times estimated the "excess death" toll from the storm to be 1,052, based on comparisons with previous years.In May, a team that included researchers from Harvard University published a study in the New England Journal of Medicine estimating that 793 to 8,498 people died in Maria's wake, a range that some academics have criticized as overly broad. The study's midpoint estimate -- 4,645 deaths -- became a rallying cry for activists upset by what they see as a lack of accountability for the scale of the catastrophe by officials in Puerto Rico and the United States.The Harvard estimate was based on surveys of 3,299 households in Puerto Rico, in which residents were asked about deaths in their homes after Hurricane Maria.Mercader, the Puerto Rico official, criticized that study in an interview with CNN on Thursday. "We all know that's impossible, that that couldn't happen," he said of the estimate that 4,645 people may have died after Maria. "We have the data. You all know that is an exaggeration."Then last week, a research letter published in the medical journal JAMA estimated that between 1,006 and 1,272 people died in relation to the storm -- with a midpoint estimate of 1,139.An accurate death toll is important, according to officials and academics, because it can help Puerto Rico and other governments better prepare for future storms, which are expected to become worse in the era of climate change. The official count also matters a great deal to the families of the deceased. Not only are they eligible for certain federal aid if the deaths are officially counted, but some relatives of the dead simply want their loved ones to be remembered."They were not numbers; they were people," Lisa De Jesús, whose friend Reinaldo Ruiz Cintron died while working in hurricane cleanup, told CNN in June. "And the government thinks that just p