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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 Department of Justice is suing to block California laws that extend protections for immigrants living in the United States illegally, commonly referred to as "sanctuary laws."The lawsuit by the Trump administration claims three of the state's laws intentionally undermine federal immigration law, according to The Associated Press.One of the laws prevents local police agencies from asking people about their immigration status or assisting in federal immigration enforcement activities. The Justice Department says these laws are unconstitutional.Attorney General Jeff Sessions, speaking at a law enforcement event in Sacramento Wednesday, said the administration's lawsuit against California was to "invalidate these unjust immigration laws" because the state's laws are a "violation of common sense."Sessions told those in attendance at the California Peace Officers Association's Legislative Day that the state has "a problem" and told California officials to "stop actively obstructing law enforcement … stop protecting lawbreakers."The attorney general singled out Oakland Mayor Libby Schaaf, who recently issued a public warning of an impending immigration raid in her city. Sessions claims that Immigration and Customs Enforcement officers "failed to make 800 arrests" because of Schaaf's statements. 1320

The forensic pathology industry is facing a workforce shortage. These are the men and women who determine how and why a death happens. They are being overwhelmed, and the pandemic has only made things worse.“What you’re seeing now is part of our autopsy examination room,” said Francisco Diaz as he walked around the Office of the Chief Medical Examiner in Washington D.C. He is the deputy chief medical examiner.“The purpose of the medical examiner is to do two things, to determine why people die and to classify the manor of death,” he said.Diaz and his team have their hands full. Here, bodies are brought in, x-rayed, and analyzed every day. Most of them are bodies of those who have died of unnatural causes, like homicide, suicide, and certain accidents.They’re brought here, where seven forensic pathologists work.“As medical examiners and forensic pathologists you are dealing with death and tragedy every single day,” he said.This year the volume has been higher than usual, in large part because of the COVID-19 outbreak. “The peak of our pandemic was April, May. At that time we had that emergency morgue off campus,” Diaz explained. “We handled approximately 400 descendants or dead bodies.”The increase in autopsies needed is not only due to COVID-19 directly, but other ripple effects.“What I see as a consequence of the pandemic is a lot of people are dying at home because they choose not to seek medical attention because they may have concerns that they may get contaminated at hospitals,” Diaz said.If they die at home, they’re sent straight to D.C.’s Medical Examiner’s Office. Most people who die in a hospital are handled by the hospital, except for in certain jurisdictions like D.C. where they will help out with the hospital's cases as well.Regardless of where the cases are coming from, jurisdictions are strapped for resources. It’s a problem across the industry right now -- one that’s been facing a workforce shortage for years.“A lot of the policy makers think that it's a waste of money. You're just spending money on the dead, but everything we do is for the living,” said Victor Weedn, Forensic Science Professor at George Washington University. He’s an expert in the forensic pathology industry.“We are terribly undermanned, under served these days. It is thought we have 500 to 600 board certified forensic pathologists working in the field across the United States and that's simply not enough. It’s estimated we really ought to have 1,200 to 1,500 forensic pathologists.”The lack of workers has become more evident due to the pandemic, and also a growing epidemic. “And then the opioid crisis hit. That immediately caused 10% to 30% more cases because of all the overdose deaths,” Weedn said. “On top of that you have the COVID pandemic. The overdose cases have not declined, in fact they've continued to increase. And now we’re seeing a wave of homicides increasing our caseload still further. We are facing a true workforce shortage.”Weedn also talked about how some of their investigations on COVID-19 patients who passed helped answer some questions we had early on in the pandemic.Increasing a workers caseload is not a great option, according to Weedn. The National Association of Medical Examiners has accreditation standards.“A forensic pathologist really isn't supposed to do more than 250 autopsies a year. If you have more than that it’s considered an infraction of the standard,” he said. “When you start doing more than that, things get lost. Details get lost.”This puts many offices in a bind. “In the face of such a severe workforce shortage you find that people have changed the criteria for what deaths they will investigate and that means there are certain deaths that will go uninvestigated. A murderer could get away with murder. That’s certainly a possibility,” Weedn explained.As the workload remains heavy for many jurisdictions, Diaz said education and exposure for the industry might be their best bet in getting more interest.“I think every crisis brings an opportunity. And I think this is an opportunity for forensic pathology to be on the forefront and let the public at large know what we do, how we do it, and to encourage young people to pursue a career in forensic pathology,” Diaz said. 4266

The FBI seized recordings President Donald Trump's attorney made of his conversations with a lawyer representing two women who had alleged affairs with Trump, a source familiar with the matter tells CNN.The recordings could prove valuable to the government's criminal investigation of Michael Cohen. The President's personal attorney is under scrutiny in part for his role in seeking to suppress the alleged affair through a hush deal with porn star Stormy Daniels. The warrant sought information about that payment along with any information that connected Cohen with efforts to suppress disclosure of Trump's alleged affair with Playboy model Karen McDougal.The warrant for the raids also specified that Cohen was being investigated for bank fraud, wire fraud and campaign finance issues, CNN reported earlier this week.While Cohen has admitted to no wrongdoing, the intensity of the government's investigation will put significant pressure on one of the President's closest confidants. If Cohen chooses to cooperate rather than fight a potential case against him, then his knowledge about the President's activities could create serious problems for Trump as special counsel Robert Mueller continues his investigation.The source said Cohen recorded some calls he had with attorney Keith Davidson, who at the time represented both Daniels and McDougal. Davidson no longer represents either woman. Their deals to keep their stories about alleged affairs quiet are now the subject of litigation, with each seeking to be released from their agreements.Another source tells CNN that in at least one conversation between the two men, "Cohen was being unusually simplistic, like he had bullet points that he was reading from to try and make himself look good. He was trying to clarify the timeline of the agreements made with Davidson in his (Cohen's) favor.""Attorney Davidson never consented to any recordings of his conversations with Mr. Cohen. If they in fact do exist, Attorney Davidson will pursue all his legal rights under the law," Dave Wedge, a spokesman for Davidson, said. Recording phone conversations without the consent of both parties could be a legal issue if Davidson was in a state that has such laws, like California.Cohen's attorney and a spokesman for Cohen's attorney did not reply to requests for comment.Prosecutors are "going to be very excited at the prospect of having an independent means of corroborating what was said between the two parties," CNN legal analyst and former federal prosecutor Michael Zeldin said. "If all that stuff gets recorded, then they are in deep hurt because if it was just oral between them, it could be a conspiracy of liars but the tapes undermine that."Zeldin said a conversation between attorneys for different clients would most likely not be considered covered by attorney-client privilege.McDougal alleges in a lawsuit that Cohen has a cozy relationship with Davidson. She argues Davidson was part of a "broad effort to silence and intimidate her and others." Davidson denies that claim.In an exclusive interview with CNN last month, Davidson described several calls he had with Cohen about striking a deal for Daniels to keep her story quiet.Davidson also said he was contacted in recent weeks by Cohen, who encouraged him to go out and reveal what he knew about his clients and their agreements. Davidson said Cohen argued that the women had waived attorney-client privilege by going public with their stories."He suggested that it would be appropriate for me to go out into the media and spill my guts," Davidson said.There was no discussion of recordings during a court hearing on Friday to argue over Cohen's filing of a temporary restraining order that seeks to suppress the evidence gathered in the raid.The Davidson recordings may not be the only conversations the FBI gathered in the raid. Cohen often recorded telephone conversations both before and during the 2016 presidential campaign that also could have been scooped up in the FBI raid on his apartment, office and hotel room, sources told CNN.One source said Cohen played to Trump and some associates conversations that he had with political and media figures during the exploratory part of the campaign.The-CNN-Wire 4249

The CDC is recommending Americans not travel for Thanksgiving during the current spike in coronavirus cases nationwide.“As cases continue to increase rapidly across the United States, the safest way to celebrate Thanksgiving is to celebrate at home with the people you live with,” the Centers for Disease Control and Prevention website reads. “Travel may increase your chance of getting and spreading COVID-19. Postponing travel and staying home is the best way to protect yourself and others this year.”This is the strongest urging from the health agency, which is part of the Health and Human Services Department, asking Americans to take stricter precautions to slow the spread of the coronavirus.There are more than 11 million reported cases of COVID-19 in this country since the pandemic started, and more than 250,000 Americans have died."We're seeing exponential growth in cases," CDC COVID-19 incident manager Dr. Henry Walke said during a press briefing. "The opportunity to translocate disease or infection from one part of the country to another leads to our recommendation to avoid travel at this time."If people are still planning to travel for the Thanksgiving holiday, the CDC has a series of questions on their website for travelers and family members to consider before going ahead with travel plans.Questions include: Are you, someone in your household, or someone you will be visiting at increased risk for getting very sick from COVID-19? Are cases high or increasing in your community or your destination? Are hospitals in your community or your destination overwhelmed with patients who have COVID-19? Do your plans include traveling by bus, train, or air which might make staying 6 feet apart difficult?“We understand that people want to see their family and relatives and do it as they’ve always done it. But this year we’re asking them to limit their travel," Dr. Walke said. The CDC also recommends those who travel to follow all of their guidance for slowing the spread of coronavirus: wear a mask, wash hands, social distance, get the flu shot, and bring extra masks and hand sanitizer.Whether or not there is travel involved, the CDC also recommends some safety precautions when celebrating Thanksgiving with a group of people.These include bringing individual utensils, plates and cups to reduce sharing, wear a mask when around people not in your household - even indoors, use single-use options when possible to reduce sharing.Consider eating outside and limit the number of guests, the CDC says. Also, clean and disinfect touched surfaces between use. If indoors, open windows and doors to allow ventilation.“Celebrating virtually or with the people you live with is the safest choice this Thanksgiving,” the CDC states. 2761

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