上海谁家算命准(吴江哪里算命准) (今日更新中)

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 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 football schedule starts as early as the weekend of Sept. 5 with final games slated for Nov. 21 to align with academic calendars. The Big Ten Football Championship Game remains scheduled for Dec. 5 at Lucas Oil Stadium, though it could be moved as late as Dec. 19. pic.twitter.com/vWp3OSifBc— Big Ten Conference (@bigten) August 5, 2020 348

The deaths of 22 more children from flu-related causes were reported Friday by the US Centers for Disease Control and Prevention in its weekly surveillance report.Those deaths bring the total number of children reported to have died to 84 since October, when the current flu season began. Three out of four children who died from the flu had not gotten a flu vaccine, the acting director of the CDC said in a Thursday news conference. "We continue to recommend parents get their children vaccinated even though it's late in the season," Dr. Anne Schuchat said. The season may continue for several more weeks, she added.  633

The coronavirus outbreak has put a hold on many things over the last few months, including some elective surgeries.When Nohely Uriostegui and her husband, Jose Pava, found out they were pregnant with a little boy, they were ecstatic. Then, the unfortunate news: their baby had spina bifida."After that, she said we’re going to do a test. You might be eligible for an in-utero surgery," said Uriostegui.That means surgery while the baby is still in the womb, and it had to be performed before 26 weeks of pregnancy. Everything was set up to go in Chicago until a phone call came from her doctor."He said, 'You know what? Based on COVID, everybody here on the team doesn’t feel like it’s an essential type of surgery,’" recalled Uriostegui.The same situation was unfolding for all types of patients around the country. Those hoping surgery could help their chronic pain were told they’d have to endure it for months longer. Organ transplant candidates were forced to wait as well. For Nohely and Jose, a delay meant they might miss their window to help their baby. But then, hope from three states away in Colorado."For this family, the clock was ticking. She had until she was 26 weeks to have fetal intervention, and that was literally five days, four days away. And they had to get from Chicago to here, be evaluated, have surgery set up to be performed, and so, we were able to do that for them," said Colorado Fetal Care Center surgeon Dr. Ken Liechty.The couple decided to travel to Colorado to have the procedure done."I got there on the 4th; my surgery was set for Monday, April 6, which was the exact same date that I was going to get it done in Chicago, and it was one day before I hit the 26-week mark," said Uriostegui."It’s open fetal surgery on the fetus as the actual patient," said Dr. Liechty. "We excise the cyst, we put the spinal cord back into the spinal canal."Doctors then put the muscle back over to seal it, close the skin over it, and then close the uterus. Without the in-utero surgery, Dr. Liechty says 90 percent of babies with spina bifida have a shunt put in to decompress the brain. However, that likely wouldn’t have been the only surgery he would have needed."These shunts fail, they can get infected, they can have all kinds of problems, they average seven surgeries at least for these shunts in their first few years of their life," said Dr. Liechty.In the time of this pandemic, that could mean more waiting as hospital beds begin to fill back up with coronavirus patients."COVID-19 caused a lot of places around the country to reexamine what cases could be done in their facilities, and a number of fetal centers are actually located in adult centers," said Dr. Liechty.Those places are filling up faster than children's hospitals, causing families like Uriostegui and her husband to almost miss opportunities to help their children before they even enter the world."The neurosurgeon over there actually said to us last time, that if you were to look at him, you would have never guessed that he’s born with spina bifida or that we went through this whole journey," said Uriostegui. 3126

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