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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 coronavirus pandemic has already caused depleted toilet paper shelves and concerns about meat shortages, but now it’s also to blame for some other, maybe more surprising shortages across the country.Coca-Cola announced at the beginning of July that it was stopping production on Odwalla Juice at the end of the month. On a call with investors, James Quincey, Chairman & Chief Executive Officer of The Coca-Cola Co. said of Odwalla, “In the case of a brand like Odwalla and its chilled direct store delivery, which has struggled over the last several years, we started to stop operations effective July 31. This gives us the flexibility to support our investments in brands like Minute Maid and Simply.”And if you thought you were imagining fewer types of Coke products on store shelves, there’s a good chance you weren’t. A representative from the soft drink giant said in an email, “We continue to see high demand for products consumed at home. We are implementing contingency plans as best we can to get the products people want to store shelves. We appreciate everyone’s patience as we work through these unprecedented times,” going on to say, “we are focusing on the availability of our most popular brands.”“Coke is facing is a different sort of thing right now; it's something that's a shift in demand, which is temporary, and they're not in position to respond to it other than to…put all of their eggs into the baskets that are going out the door fastest,” said William Dickens, University Distinguished Professor and chair of the economics department at Northeastern University.Another issue for Coke likely ties into another shortage – aluminum cans.According to Robert Budway, the president of the Can Manufacturers Institute, the aluminium can industry was seeing demand increase even before the pandemic began because cans are more environmentally friendly than plastic bottles, and the demand has only gone up.“Can manufacturers are fully focused on filling the extraordinary demand from all sectors of the industry’s customer base,” said Budway in a statement. He also said that although there is enough aluminum, can makers have announced the construction of several new plants in the United States and Canada, but they will take between 12 and 18 months to build.Chains like Taco Bell announced they’re trimming the menu too, removing things like the 7-Layer Burrito and Nachos Supreme. And Red Robin Gourmet Burgers ditched a third of its menu.The national burger chain cut 55 items, and a representative pointed to what they told their investors about the changes saying the cuts have resulted in “faster cook times, higher quality food” and say it’s reduced waste.“Sure,” said Dickens. “But why wouldn't they have done it before this, if it made such a big difference? The best explanation is that now they're in a different circumstance, and they just can't afford to produce the type of variety that they did before because they aren't having as many people coming in.”Dickens said everything, each menu item and each flavor of soda, has a specific cost to make. For a business to be profitable, it has to sell a certain number of each offering.So it makes sense that less popular items might hit the road right now.“As for menus and shortages…I think we may very well see more firms follow suit. I know my favorite restaurant is only offering a couple of items compared to what it used to. So I know it's a phenomenon that's out there,” said Dickens. “It's more profitable for [restaurants] to focus on a couple of items that they know that they're going to sell a lot of.”He went on to say what we can expect to see in the next month or year largely depends on how things go with COVID-19 and the subsequent handling of the economy.“I guess my biggest fear is that we're mishandling the economy,” said Dickens.He said that the United States’ economy hasn’t shrunk as much as it might have since the pandemic hit because Congress authorized an extra 0 per week for unemployment benefits. He said that the people who are getting those benefits are also then spending that money on things like food and drink.With the final unemployment supplements already distributed, Dickens predicts people will have less money to spend, which in turn will mean less money in the economy overall, more job layoffs – and a deeper recession. He said that could ultimately mean more shortages – and more businesses closing for good.“We should not let the smart things that were done fade away too early, and this is clearly too early since a large part of the country is still seeing growing numbers of cases,” said Dickens. “They're probably going to have to take action to pull back from re-opening and people are gonna need economic support.” 4769

The doors to Interior Secretary Ryan Zinke's office are getting a nearly 9,000 upgrade.The Interior Department confirmed the project Thursday, saying it is both necessary to replace old doors that are in "disrepair" and attributing the high cost to the historical nature of the building.News of the 8,670 contract comes as several agencies are facing scrutiny over excessive spending. Last month, Housing and Urban Development Secretary Ben Carson withdrew an order for pricey dining room furniture, including a ,000 table. Zinke is also under fire for questionable travel habits.Zinke was unaware of the expense for the doors, Interior spokeswoman Heather Swift said, saying the project was driven by "career facilities and security officials" as part of a decade-long modernization of the 1930s building."The secretary was not aware of this contract but agrees that this is a lot of money for demo, install, materials, and labor," Swift said in a statement. "Between regulations that require historic preservation and outdated government procurement rules, the costs for everything from pencils to printing to doors is astronomical. This is a perfect example of why the secretary believes we need to reform procurement processes."The new doors will be made of fiberglass. The previous sets of doors have been damaged for years, according to an Interior official, to the point where wind and water come into the office during inclement weather, which in turn damaged the historic hardwood floors. Damage has caused bottom panels to fall out and be "replaced with cardboard and duct tape," the official said.The Associated Press previously reported on the door contract Thursday."What a waste. Just think how many dining sets you could have bought or private jets you could have chartered with that money," Rep. Adam Schiff, D-California, joked on Twitter. 1898

The Department of Homeland Security and the Pentagon are having initial discussions that could lead to a 45-day extension of the southern border mission for US troops, according to two administration officials.DHS would have to make a specific request to the Pentagon. Under the current plan, the border mission is scheduled to end December 15.The discussion comes following tensions at the border Sunday, when about?500 migrants overwhelmed police blockades on the Mexican side of the San Ysidro port of entry, two journalists in Tijuana told CNN. US authorities used tear gas to disperse the crowds, which included families and small children, and more than 100 migrants were arrested.One of the officials said that "based on what happened on Sunday" DHS still wants the help of the Defense Department, adding that "the threat has not gone away."The agencies are also discussing whether some engineers who worked on fortifying crossing points in Arizona and Texas can now be sent home and whether more troops will shift to California.President Donald Trump sent about 5,800 federal troops to the border after spending the weeks leading up to the midterm elections decrying a procession of migrants that was still thousands of miles from the US border. Last week, Trump granted the troops new powers to aid in "crowd control, temporary detention and cursory search" while protecting Customs and Border Protection personnel from the migrants, should they engage in violence.On Wednesday afternoon, Secretary of Defense James Mattis said the Pentagon was ready to "react to the Department of Homeland Security" if it asks for any extensions. Mattis added, "Right now we have no new requests, although we are discussing every day the situation and so I can't forecast when that will be."Last week Homeland Secretary Kirstjen Nielsen said she had "no doubt that DoD will continue to be our partners in this mission until it is resolved."NPR was first to report the possible extension. 2004

The Democratic National Committee is suing the Trump campaign, Russia, WikiLeaks founder Julian Assange and several associates of President Donald Trump alleging a grand racketeering, hacking and fraudulent conspiracy that harmed Democrats through WikiLeaks' publication of internal party emails during the 2016 presidential campaign.Those named in the lawsuit include several top Trump advisers who attended the now-infamous June 2016 meeting in Trump Tower, longtime Trump confidant Roger Stone, former Trump campaign chairman Paul Manafort and former campaign adviser George Papadopoulos and others.The 66-page lawsuit filed in Manhattan federal court on Friday lays out how the Trumps curried favor in Russia through their family business, and then Russia allegedly worked with Trump advisers before the presidential election to disseminate the spoils from a cyberattack of the DNC.The Democratic Party says the conspiracy and the hacking hurt their relationship with voters, chilled donations, disrupted their political convention and subjected their staffers to harassment. The lawsuit outlines nearly every known communication between Trump advisers and Russians.The Washington Post first reported the lawsuit.Special counsel Robert Mueller was appointed by Deputy Attorney General Rod Rosenstein last year to investigate Russian efforts to interfere in the 2016 election. As part of that mandate, Mueller is empowered to investigate any links between the Russian government and Trump campaign associates.The US intelligence community has concluded that Russian President Vladimir Putin ordered "an influence campaign" in 2016 with the goal of undermining public confidence in the US democratic process and eroding Hillary Clinton's chances of winning the presidency.Trump, however, has repeatedly insisted that there was no collusion between his campaign and the Russians, and has denounced the special counsel investigation as a "witch hunt."In the summer of 2016, the Democratic National Committee went public with claims that Russians hackers had gained access to their computer systems, obtaining emails and opposition research against Trump.Then, just days before the Democratic National Convention when Clinton was set to receive the party's presidential nomination, WikiLeaks published tens of thousands of hacked DNC emails.The release of the emails, which included messages disparaging Bernie Sanders, threw the Democratic Party into turmoil at a moment when the party was supposed to be coming together in support of a nominee, and intensified in-fighting between supporters of Clinton and Sanders.  2630

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