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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 Broward County Sheriff's deputy who was assigned to be the school resource officer at Stoneman Douglas High School during last week's massacre that left 17 dead resigned this morning after being suspended without pay, Sheriff Scott Israel announced on Thursday. Israel said that Deputy Scot Peterson was outside of the building during the time of the shooting. According to Israel, video evidence suggested that Peterson remained outside for four minutes. The entire mass shooting lasted an estimated six minutes, Israel said.Related story: Parkland shooter Nikolas Cruz recorded during 911 call in Palm Beach County 648

The Environmental Protection Agency confirmed Monday the content of internal EPA emails that appear to contradict EPA Administrator Scott Pruitt's claim he didn't know about or authorize big pay raises for two close aides.However, an EPA spokeswoman said there was no evidence in the emails that Pruitt knew about the pay raises.The Atlantic reported last Monday that Pruitt requested pay raises for "two of his closest aides," in March, a request the White House declined, according to a source with knowledge of the discussion. EPA then used an obscure provision to give the staffers, Sarah Greenwalt and Millan Hupp, the raises.On Wednesday, Pruitt told Fox News, "I did not know that they got the pay raises until (Tuesday)."The EPA spokeswoman confirmed to CNN an email exchange, also first reported by The Atlantic, between Greenwalt and the human resources department at the EPA. She previously worked with Pruitt in the Oklahoma attorney general's office.In one of the emails, EPA's human resources department tells Greenwalt that it processed her title change. When Greenwalt asks what her salary increase was, the department told her there was no increase in her salary. Greenwalt responded that the administrator indicated she should have one, referring to a salary increase."There's no way to prove what she said is true; a lot of people say the administrator said this or that," said the EPA spokeswoman, who reached out to CNN to explain the emails.The spokeswoman confirmed she saw the emails and confirmed the content of the emails. No specific dollar amount for the raise was mentioned in the email exchange, according to the spokeswoman."While she may claim that the administrator knows about her raise, there is no email proof that I've seen, or communications or documents from Scott Pruitt to HR or to (Greenwalt) about that particular raise," the spokeswoman said.On Monday, EPA chief of staff Ryan Jackson said in a statement to The Atlantic that he is taking responsibility for the raises and that Pruitt "had zero knowledge of the amount of the raises, nor the process by which they transpired."The EPA spokeswoman confirmed the existence of a second email from the liaison between the White House and EPA to the agency's human resources department expressing concerns from the White House about such significant raises, but noting that the administrator had indicated to move forward with it.In an effort to explain that email, the spokeswoman said despite the content of the second email, what that person really meant was "the administrator's office," not the administrator himself, decided to go ahead with the raises.Pruitt has come under increasing fire in recent weeks as reports steadily uncover extensive spending on travel and other potentially major ethical lapses, including an agreement to rent a room in Washington for only a night from a lobbyist couple whose firm lobbies the EPA.President Donald Trump said last Thursday he still had confidence in Pruitt.  3015

The Collective Brewing project has teamed up with Lone Star Taps and Caps in Fort Worth, Texas to turn Easter's most polarizing treat—Marshmallow Peeps—into a craft beer. They plan to tap the concoction Friday, March 30 at 6 p.m. at the Taproom in Fort Worth, and they're calling the collaboration "Peep this Collab."On the website, the taste is described as tart and lemon-y and the look is described as a glitter bomb with fabulous sparkle. However, Ryan Deyo, Collective Brewing's head brewer and co-founder said drinkers could expect a "lightly tart" and marshmallow-y" taste from the beer on guidelive.Regardless of the flavor, Deyo said they mashed 30 boxes of peeps into a beer brewed with sour ale, vanilla and butterfly pea flowers (yes, actual flowers). If that doesn't sound delicious already, the beer will have purple tint thanks to the pea flowers and they will have edible glitter to up the sparkle content. This whole idea is a part of Deyo's passion to make beer for more fun."I've been on a kick to assert beer should be a fun thing," Deyo told guidelive. "We make a beer with ramen noodles, so Peeps isn't really a stretch."If Ramen Noodle beer sound just as good as peep beer, you're in luck, but neither of those flavors top the wackiest ever made by craft brewers. Flavors like Rocky Mountain Oyster, Oyster, Coconut Curry and Pizza beer have turned heads in the past.  1439

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