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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 erratic stock market just made a serious comeback.Fears about slowing earnings growth sent the Dow careening 549 points lower on Tuesday before the index raced back to life.By the closing bell, the Dow was only down 126 points, or 0.5%.Similarly, the Nasdaq closed down 0.4%, erasing the vast majority of a 2.6% plunge. The index also climbed out of a technical correction, a 10% decline from prior highs.The S&P 500 suffered its fifth straight loss. But the broad index finished just modestly lower after touching its weakest point in nearly four months.Market veterans saw little reason for the dramatic recovery -- other than the fact that stocks had gotten to oversold levels."It was an impressive day. We reversed on very little news," said Art Hogan, chief market strategist at B. Riley FBR.Hogan pointed to how the rebound was led by two of the most beaten-down corners of the market: homebuilders and chip makers.Stocks sold off early on Tuesday after major US companies reported gloomy results and guidance. Disappointing numbers from Caterpillar and 3M reinforced ongoing concerns about how long blockbuster profits can last, especially given tariffs and rising costs."Investors are skittish about whether we've seen a peak in earnings," said Mark Luschini, chief market strategist at Janney Capital Management. "It's a schizophrenic market environment where things that didn't matter suddenly do."It's been a scary month for investors. The Dow and Nasdaq are on track for their worst months since January 2016."The market is fragile," said Rich Guerrini, CEO of PNC Investments. "But we're telling our investors to relax. We're in a correction. I think the market does have some legs left."The CNN Business Fear & Greed Index slipped further into "extreme fear." A month ago the gauge of market sentiment was flashing "extreme greed."Wall Street was also spooked by extreme turbulence in China, the epicenter of the trade war. The Shanghai Composite dropped 2.3% overnight. The sell-off wiped out a chunk of Monday's spike, the benchmark index's best day since March 2016. 2114

The FBI is warning financial institutions that their ATMs could be targeted in a hacking attempt.The threat was reported Sunday by Krebs On Security, a popular cybersecurity blog run by the journalist Brian Krebs.Krebs reported that the scheme is known as an "ATM cash-out," which means the attackers can hack a bank or payment card processor and use stolen information to withdraw large sums of money at ATMs worldwide. His report cited a confidential alert the FBI shared with banks last Friday.The FBI did not comment specifically on this potential attack. In a statement to CNN, a spokeswoman said that "in furtherance of public-private partnerships, the FBI routinely advises private industry of various cyber threat indicators observed during the course of our investigations.""This data is provided in order to help systems administrators guard against the actions of persistent cyber criminals," the spokeswoman said.CNN reached out to two major banks, Wells Fargo and JPMorgan Chase, both of which declined to comment.Krebs has reported on similar "unlimited operations" before, including a scheme in which more than million was stolen from a Virginia bank in 2016 and 2017.The alert, called a private industry notification, was sent to a narrow group of cybersecurity professionals and system administrators at financial firms that had assets at risk, according to a federal law enforcement official.Though the FBI at times makes PSAs for significant cybersecurity threats, like when they told the public in May to reboot certain internet routers after a malware attack, no wider notification was made about the ATM scheme. 1659

The CDC announced Friday a pilot project intended on decreasing chronic diseases in high-risk communities. The government is putting million toward the project to address five areas of social detriments.Some groups—including racial and ethnic minorities, those living in poverty, and people in certain parts of the country—are disproportionately impacted by the burden of chronic conditions, the CDC said.“Chronic diseases touch every American, in one way or another,” said Karen Hacker, M.D., M.P.H., director of CDC’s NCCDPHP. “This important pilot project will help us better understand strategies to advance health equity and reduce the immense burden of chronic disease.”The program will address five areas on concern, said the CDC:Built environment: human-made surroundings that influence overall community health and individual behaviors that drive healthCommunity-clinical linkages: connections made among health care systems and services, public health agencies, and community-based organizations to improve population healthFood insecurity: an economic and social condition characterized by limited or uncertain access to adequate and nutritious foodSocial connectedness: the degree to which individuals or groups of individuals have and perceive a desired number, quality, and diversity of relationships that create a sense of belonging and being cared for, valued, and supportedTobacco-free policy: population-based preventive measures to reduce tobacco use and tobacco-related morbidity and mortality.The CDC said it will work with the Association of State and Territorial Health Officials and the National Association of County and City Health Officials to identify community to join the pilot program. 1727

The company behind Ben & Jerry’s ice cream, Dove soap and a host of other consumer products says it will stop advertising on Facebook, Twitter and Instagram in the U.S. through at least the end of the year because of the amount of hate speech online. Unilever said that the polarized atmosphere in the United States ahead of November's presidential election placed responsibility on brands to act. The company, which is based in the Netherlands and Britain, joins a raft of other companies halting advertising on online platforms. Facebook in particular has been the target of an escalating movement to siphon away advertising. 639

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