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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 caddies for Graeme McDowell and Brooks Koepka have tested positive for the coronavirus. And now both major champions have decided to withdraw from the Travelers Championship. Both say they are withdrawing to protect the rest of the field.McDowell says it feels like the snowball is getting bigger.On Tuesday, the PGA Tour announced that Cameron Champ withdrew after testing positive for the deadly virus. 416

The devastation left by Hurricane Michael in several states is still coming into focus, with coastal Florida cities destroyed beyond recognition, and homes, businesses and agriculture torn or swamped from Georgia to Virginia.More than 1 million customers were left without electricity, and emergency officials have no access to many towns. The US death toll has risen to at least 17 -- including five in Virginia and eight in Florida -- and it's expected to climb."I expect the fatality count to rise today and tomorrow as we get through the debris," Federal Emergency Management Agency Administrator Brock Long said Friday morning.Michael, which smacked Florida's Panhandle as one of the most powerful hurricanes to hit the United States, left Virginia's coast as a post-tropical low early Friday -- and its trail of destruction will take weeks to take into account.Aerial footage shows coastal cities in the Panhandle, like Mexico Beach, wiped out. Search teams used dogs as they combed the area for people killed or trapped in debris.One death was reported in Mexico Beach -- that of an elderly man found alone, Mayor Al Cathey said.City manager Tanya Castro said Mexico Beach won't be up and running for 12-18 months and advised people who evacuated not to return.Dawn Vickers rode out the storm in Mexico Beach, but her house and vehicles were demolished. Without cell phone service or transportation, she has been taking shelter in one of the few condos left standing, invited by someone she met at what's left of a gas station."This has been the worst nightmare I've ever been through in my life," she told CNN on Friday.A psychiatric hospital in Florida is isolated after downed trees blocked roads around Chattahoochee, and a tree caused a water line to break. The facility is running on power generators, and helicopters have delivered food and water, the state's Department of Children and Families said. 1938

The federal government is running up its credit bill again.The deficit rose to 9 billion in fiscal year 2018, up 17% from last year, according to final figures released Monday by the Treasury Department. That's the largest number since 2012, when the country was still spending massively to stimulate an economy struggling to recover.Government receipts were flat this year from last year. Corporate tax collections fell billion, or 22%, due to the Republican-backed tax cut. But that drop was more than offset by increased revenues from individual and self-employment taxes. The fiscal year ended September 30.Spending rose 3% over the previous year, fueled in part by increases to the defense budget agreed upon in September 2017 as part of a deal between Republicans and Democrats to head off a government shutdown. Social Security and interest on the federal debt also contributed to the increase.The Committee for a Responsible Federal Budget, a think tank that warns of the dangers of rising debt levels, said the deficit could reach trillion as soon as next year. That would still be below a high of .4 trillion reached in 2009, but in a vastly different economy."Those elected to Congress this year will face stark and difficult choices to put the debt on a downward path and protect our nation's social programs from insolvency," said Maya MacGuineas, the group's president. "It's no longer a problem for the future."The White House has steadfastly defended its policies, arguing that the yawning gap is a reason to cut deeper into social programs to balance out increases to the military budget. It's a long way from the Republican stance under President Barack Obama, when the GOP-led House demanded about trillion in budget cuts over 10 years in exchange for a debt ceiling increase, leading to years of painful automatic reductions to federal spending.White House budget director Mick Mulvaney, a notable debt hawk while he was a congressman, said the numbers underscored a need to cut spending."The president is very much aware of the realities presented by our national debt," Mulvaney said in a statement. "America's booming economy will create increased government revenues — an important step toward long-term fiscal sustainability. But this fiscal picture is a blunt warning to Congress of the dire consequences of irresponsible and unnecessary spending."His comments echoed remarks by Treasury Secretary Steven Mnuchin last week in an interview with CNN suggesting that Democrats' resistance to cutting government spending on education, health care and other social programs was to blame for deficit increases."People are going to want to say the deficit is because of the tax cuts. That's not the real story," Mnuchin told CNN. "The real story is we made a significant investment in the military which is very, very important, and to get that done we had to increase non-military spending."Not many non-military spending categories increased, however. Outlays for the departments of Housing and Urban Development, Transportation, Energy and Education all decreased, while Health and Human Services and Veterans Affairs increased slightly. The Agriculture Department saw a 7% bump from last year.The deficit figure is?in line with what the Congressional Budget Office, the official government scorekeeper of federal fiscal policy, projected earlier this month. In June, the CBO projected that the deficit would rise to 9.5% of GDP in 2018.Also in June, the federal debt — which aggregates annual deficits over time — stood at 78% of gross domestic product, the highest level since right after World War II. Updated figures were not immediately available on Monday.As interest rates rise, servicing that ballooning debt could pose challenging. Treasury spent 2 billion last year paying interest, up 14% from the year before. That's more than the cost of Medicaid, food stamps, and the department of Housing and Urban Development combined. But it is smaller as a percentage of GDP than it has been historically.In late September, the House passed a bill that would extend individual tax cuts that are currently are slated to end in 2025, at a cost of 1 billion over a 10-year window. 4260

The Food and Drug Administration issued an emergency use authorization on Tuesday to a rapid at-home coronavirus test, the first of its kind to receive such an approval.The Lucira COVID-19 All-In-One Test Kit tests can be administered at home via nasal swab. Within 30 minutes, a test display will light up to give the patient’s results. The FDA says that those who receive a negative COVID-19 test but display symptoms should continue to quarantine as a negative test does not preclude someone from having the virus.Those ages 14 and over can self-administer the test at home. Juveniles must have the test administered by a health care professional.“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”Previously, the only at-home tests for the coronavirus required samples to be sent to a lab, which meant the time to get results was significantly delayed. 1342