井研哪里算卦比较准(庆安哪里算命准) (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 flu vaccine may have an important benefit beyond protecting against influenza: It may also prevent heart attacks, especially in those at high risk, experts say."It's been a long time that people have recognized that association with flu season and development of a heart attack," said Dr. Kevin Schwartz, an infectious disease physician at Public Health Ontario.When it comes to preventing heart attacks in people with cardiovascular problems, experts have put getting the flu vaccine on par with long-term measures such as quitting smoking or taking one's medication for high blood pressure.  610

The country is heading into a COVID-19 winter without fully deploying widespread testing of sewage for traces of coronavirus, a Newsy investigation has found.Wastewater surveillance is one of the few proven tools able to track community spread of the disease, with the potential to help monitor immunity rates from new vaccines."It is frustrating," said David Larsen, an associate professor of public health at Syracuse University's Falk College. "We're going to see a huge amount of sadness over the next few months. And it's not too late to scale up wastewater surveillance at this time to help us with that."Early on, scientists realized infected people shed the virus in stool.The federal government began a big effort for analyzing the concentration of the virus in community wastewater."It's something I think from a national level we need to pursue," Assistant Secretary for Health ADM Dr. Brett Giroir said during a July webinar.Months later, the government has left it to state and local authorities to launch their own programs.For some, that's been a challenge.Newsy learned New York State, for example, suspended its sewage surveillance pilot after a month in part because of an equipment shortage.As a result, testing stopped in four places including Albany and Erie County, home of Buffalo.The University of Buffalo helped lead the project."UB is in the process of acquiring enough materials to continue the monitoring effort moving forward," university spokesman Cory Nealon said in an emailed statement.As with PPE, there is a global shortage of supplies needed to test sewage for COVID.Other places are struggling with how to pay for sewage analysis, with coronavirus aid from Washington running dry."The biggest factor, the limiting factor, is finances," Larsen said.The result is a patchwork of places examining wastewater across the country, mainly big cities and college campuses."It's not really a unified strategy, unfortunately," said Colleen Naughton, an assistant professor of civil and environmental engineering at the University of California Merced.She and her team plot testing sites on a map."When you zoom out of course the bubbles are big, so it looks like all U.S. is covered," Naughton said. "But when you zoom in you see it's a bit more spread out."Three states, Iowa, Rhode Island and South Dakota, don't have any surveillance sites at all, she said.Biobot Analytics looks for COVID in wastewater for about 200 cities and counties but has the capacity to do much more, said company president and cofounder Newsha Ghaeli."We're at the beginning, let's say that," Ghaeli said. "There hasn't really been a strong coming together yet around a specific approach or even standards."The CDC is still putting together a national wastewater surveillance system, building out a database not available to the public yet."It is, I think, valuable for the public to see that data and take action as a deciding factor for what activities and what risks am I going to take?" Naughton said. 3019

The CEOs of T-Mobile and Sprint are confident that their proposed merger will get approval from US regulators and create jobs — and that it won't raise prices for wireless subscribers.T-Mobile's John Legere and Sprint's Marcelo Claure told CNN's Richard Quest on Monday that the merger of the two companies would make it easier for them to build out a national, high-speed 5G network before their rivals Verizon and AT&T do."The country needs 5G," Claure said. He said the United States can't fall further behind China and South Korea, which are ahead in deploying 5G technology. 591

The Federal Reserve says economic activity has picked up in most regions of the country but still remains well below pre-pandemic levels with the country facing high levels of uncertainty.The Fed reported Wednesday that its latest survey of economic conditions around the country found improvements in consumer spending and other areas but said the gains were from very low levels seen when widespread lockdowns push the country into a deep recession.And the report said that business contacts in the Fed’s 12 regions remained wary about the future.“Outlooks remained highly uncertain as contacts grappled with how long the COVID-19 pandemic would continue and the magnitude of its economic implications,” the Fed said in its latest Beige Book.Economists said the Fed survey underscored how uncertain the outlook was at present.“Last month’s optimism as businesses were reopening has since given way to concerns over reinforced shutdowns, announced delays in school openings and growing consumer fears,” said Curt Long, chief economist of the National Association of Federally-Insured Credit Unions. “A smooth path back to normal was never likely, but it will still leave consumers and businesses more cautious until a vaccine is ready and widely available.”The information in the report will provide guidance for Fed officials at their next meeting on July 28-29. Economists expect the central bank to keep its benchmark interest rate at a record low as it tries to cushion the economy from the pandemic downturn.The Beige Book found only modest signs of improvement in most areas, noting that consumer spending had picked up as many nonessential businesses were allowed to reopen, helping to boost retail sales in all 12 Fed districts but construction remained subdued.Manufacturing activity moved up, the report said, ’but from a very low level.”The economy entered a recession in February, ending a nearly 11-year long economic expansion, the longest in U.S. history. Millions of people were thrown out of work and while 7.3 million jobs were created in May and June that represented only about one-third of the jobs lost in March and April.And now, in recent weeks with virus cases surging in many states, there are concerns that the fledgling recovery could be in danger of stalling out.The Beige Book reported that employment had increased in almost all districts in the latest survey, which was based on responses received by July 6, but layoffs had continued as well.“Contacts in nearly every district noted difficulty in bringing back workers because of health and safety concerns, child care needs and generous unemployment insurance benefits,” the Fed said.The report said that many businesses who had been able to retain workers because of the government’s Paycheck Protection Program said they might still be forced to lay off staff if their businesses do not see a pickup in demand.The Fed in March cut its benchmark interest rate to a record low of 0 to 0.25% and purchased billions of dollars of Treasury and mortgage-backed bonds to stabilize financial markets.But Fed officials have recently expressed concerns that a resurgence of the virus in many states may require more support from the central bank and from Congress.Fed board member Lael Brainard said in a speech Tuesday that the economy was likely to “ face headwinds for some time ” and that continued support from the government will remain “vital.”The Trump administration has said it plans to negotiate another support package once Congress returns from recess next week. Republicans and Democrats remain far apart on what should be in the new package with Democrats pushing for a package of around trillion while GOP lawmakers have called for smaller support of around trillion.Congress will only have two weeks to reach a compromise before two of the most popular programs providing paycheck protection for workers and expanded unemployment benefits expire. The unemployment support provided an extra 0 per week but many Republicans say that amount was too high and kept some people from returning to work. 4106

来源：资阳报