濮阳东方妇科预约电话(濮阳东方医院男科阳痿效果) (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 Department of Homeland Security formally requested that the Pentagon extend the deployment of active-duty troops on the southern border Friday, potentially extending their deployment 45 days beyond the original deadline of December 15."Given the ongoing threat at our Southern border -- today the Department of Homeland Security submitted a request for assistance to the Department of Defense to extend its support through January 31, 2019," Department of Homeland Security spokeswoman Katie Waldman told CNN in a statement."This request refines support to ensure it remains aligned with the current situation, the nature of the mission, and (Customs and Border Protection) operational requirements," she added.The Pentagon confirmed receipt of the request but said Secretary of Defense James Mattis had yet to sign off on it:"We have received the Request for Assistance from the Department of Homeland Security, it is with the Secretary (of Defense) for consideration."There are currently some 5,600 troops at the border, divided among Texas, California and Arizona.President Donald Trump sent the troops 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.Defense officials have suggested that some of the troops, primarily engineers involved in enhancing infrastructure at points of entry, could be drawn down in the relative near term as those tasks are completed.Two officials tell CNN that the number of trumps assigned to the mission is likely to drop to 4,000 as a result.Other functions, including helicopter support to help move Customs and Border Protection personnel to different areas along the border, are likely to continue.The deployment's extension means the Pentagon's initial cost estimate of million for the border deployment is likely to increase as that estimate was based on the mission ending on December 15. 2175

The Center for Disease Control (CDC) has issued a reminder to the public to stop washing and reusing condoms.The CDC said in a tweet that this reminder to all sexually-active Americans was sent out "because people do it." 229

The FBI raided Michael Cohen's office on Monday, the personal lawyer to President Donald Trump who allegedly oversaw a 0,000 payment to adult film actress Stormy Daniels in the days leading up to the 2016 election, the New York Times reported. According to the Times, Special Counsel Robert Mueller issued a referral for the raid, although the search does not appear to be directly related to his ongoing investigation of Russian meddling and possible coordination with the Trump campaign during the 2016 election. The Times report does indicate, however, that the raid stemmed from information Mueller uncovered and gave to prosecutors.In order to secure a raid, Mueller went to US Attorney Geoffrey Berman, who was appointed in January. Berman took the information to a federal judge, who green lighted the raid. Berman replaced acting US Attorney Joon Kim, who replaced Preet Bharara. Bharara was fired by Trump after he refused to resign when Trump demanded that all US Attorneys who worked under President Barack Obama to step down. Despite Berman being a Trump appointee, the President said the investigation is a "witch hunt.""I have this witch hunt constantly going on, it is a real disgrace," Trump said. "It is an attack on what we all stand for," It is at an all new level of unfairness."Attorney General Jeff Sessions vowed to stay out of the Mueller investigation shortly after being confirmed as AG. He assigned his Deputy Attorney General Rod Rosenstein to oversee Mueller's investigation. Trump admitted on Monday that had he known that Sessions would recuse himself, that he would have looked for a different attorney general."The attorney general made a terrible mistake when he did this and when recused himself or he certainly should have let us know if he was going to recuse himself and we would have put a different attorney general in," Trump said. "So he made what I consider to be a very terrible mistake for the country. But you'll figure that out."Trump was asked whether he should fire Mueller. "I think it's a disgrace what's going on. We'll see what happens..Many people have said you should fire him," Trump said. "Again, they found nothing and in finding nothing that's a big statement because you know the person who is in charge of the investigation."Cohen was reportedly responsible for paying Daniels 0,000 to keep quiet about a previous sexual encounter with Trump. Daniels has since gone public about the alleged sexual encounter, recently appearing on "60 Minutes" in an interview with Anderson Cooper. The possible payment, which Trump has claimed he has no knowledge of, has also brought questions on its legality, and whether the payment by Cohen constituted as an undisclosed campaign contribution. Cohen's lawyer on Monday told the New York Times the raid was “completely inappropriate and unnecessary.” 2927

The end of net neutrality is now scheduled for next month.The Federal Communications Commission said in a notice filed Thursday that new rules repealing the net neutrality protections are set to take effect 30 days from this Friday, or June 11."Now, on June 11, these unnecessary and harmful internet regulations will be repealed and the bipartisan, light-touch approach that served the online world well for nearly 20 years will be restored," Ajit Pai, chairman of the FCC, said in a statement Thursday.The Republican-led FCC voted along party lines in December to repeal the Obama-era net neutrality rules, which were intended to prevent internet providers from blocking, speeding up, or slowing down access to specific online services.The FCC previously said that parts of the repeal order would take effect on April 23. The rest of the order required the approval of the Office of Management and Budget, which the FCC says it received earlier this month.The new timeline comes as net neutrality advocates make a last ditch effort to undo the repeal.Related: Trump administration sends mixed messages on big mediaSenate Democrats are currently pushing for a vote on a bill to overturn the decision as soon as next week. Even if the resolution passes the Senate, it still faces an uphill battle in the House.Gigi Sohn, a counselor to former FCC chairman Tom Wheeler, recently told CNN that the future of net neutrality will likely "stay murky" through the remainder of this calendar year, "at the very least."More than 20 states have filed a lawsuit to stop the net neutrality repeal. Several states, including New Jersey, Washington, Oregon and California, have gone so far as to push legislation to enforce the principles of net neutrality within their borders.This local legislation could lead to a legal showdown, however.A spokeswoman for the FCC previously directed CNNMoney to a section of the final order for net neutrality, in which the FCC asserts authority to prevent states from pursuing laws inconsistent with the net neutrality repeal."You do have a number of states who have passed rules and they haven't really implemented them because if they do they will be sued by the operators."It's patently illegal for the states to make their own internet policy," says Roslyn Layton, a visiting scholar at the American Enterprise Institute who served on President Trump's transition team for the FCC.Layton expects telecommunications companies will sue the states if they try to enforce the protections.  2527

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