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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 global pandemic has changed what “work” looks like for millions of people, and those changes could become permanent, according to workplace and hiring experts.In a report from Glassdoor looking at job trends in 2021 they remind people that moments of crisis, like the coronavirus pandemic, can present risks and opportunities.Some companies have already announced long-term work-from-home opportunities, are embracing mental health and culture-building initiatives, and are scaling back in-person meetings and positions that are in-person focused.Part of the report focused on jobs Glassdoor predicts will either not exist or will be drastically different in the future because of the pandemic.In 2021, lower-skilled service jobs, education jobs, administrative office roles, sales roles and discretionary healthcare jobs could start disappearing. These findings are based on job listings from October 2019 to October 2020, and noticing trends of decreasing job postings during the pandemic that do not show signs of bouncing back.Some of those jobs specifically include beauty consultants, valets, pet groomers, event coordinators, executive assistants, receptionists, sales product demonstrators, product or brand ambassadors and even sales managers.In education, the higher ed system “is facing an overwhelming financial crisis due to falling enrollment and mandated campus closures, and these jobs may not return for a long time.” That includes college professors and instructors, according to Glassdoor.In healthcare, while frontline workers like doctors and nurses are in high demand, other positions are not as some health needs are being postponed or canceled altogether. Jobs for audiologists, opticians and physical therapists are all down.They do predict that jobs like nursing, warehouse worker and e-commerce sector jobs will continue to increase in number in 2021.This lines up with a recent report from the World Economic Forum that predicted about 85 million jobs around the world would become obsolete by 2025 because of the rapid change to automation and remote work during the pandemic.The WEF report also focused on jobs that will rise in the wake of the pandemic. According to the report, by 2025, roles and jobs that leverage human skills will rise in demand.Machines will primarily be focused on information and data processing, administrative tasks and routine manual jobs.The WEF says emerging professions in the next several years will be in data and artificial intelligence, content creation and cloud computing. They also say employers will be looking for these top skills among their employees: analytical thinking, creativity and flexibility.The report from Glassdoor also looked at workplace benefits and initiatives that employees will begin to expect from an employer post-pandemic and how salaries could be impacted by permanent work-from-home changes. 2898

The FDA has ended an emergency use authorization (EUA) order for hydroxychloroquine, saying that the agency has determined that drug is "unlikely to be effective in treating COVID-19."In the announcement, the agency said that the benefits of hydroxychloroquine and a related drug, chloroquine phosphate, "no longer outweigh the known and potential risks for the authorized use."The FDA issued the EUA for the drug in March. In April, the FDA warned that the drug should only be used in hospital settings due to the severe side effects some experienced while taking the drug.Shortly after the coronavirus arrived in the United States, President Donald Trump touted the drug as a potential treatment for the disease. He encouraged those sickened with the virus to take the drugs, saying, "what do you have to lose?"Trump said he took the drug for a few weeks in May as several White House staffers contracted the virus. In an open letter, White House physician Sean Conley said he prescribed the drugs after determining that the "potential benefit from treatment outweighed the relative risks."Earlier this month, a study showed that the drug was likely not effective in treating COVID-19. That study was published just days after a separate study — which determined that people who took the drugs died at a higher rate than those who did not take the drugs — was retracted by three of its authors. 1404

The CDC is considering changing its quarantine guidelines for those who have been in close contact with someone who is infected with the coronavirus.Currently, those who have been in close contact with someone infected with the virus would be advised to quarantine for 14 days. Possible new guidance would shorten the quarantine period to 10 days. At the end of the 10-day period, a test would be need to end quarantine.In an interview with CNN’s Wolf Blitzer, Adm. Brett Giroir, the assistant secretary for health at Health and Human Services, explains why a 10-day quarantine might be more effective at getting more compliance with the guidance."People are much more likely to listen to a 10-day quarantine than they are a 14-day quarantine,” Giroir said. “If we can shorten it safely with most risk because we have a quarantine plus a test, we have a lot of tests available now, that might improve our public health responses.”Giroir stressed that final guidelines have not been approved, and the current guidance still calls for a 14-day quarantine.“It's not an announcement that is happening but we are reviewing it and the CDC team is modeling it and looking at data every day,” Giroir said.“And it may change or it may not. Just depends on where the data and the evidence wind up." According to the CDC, a person can become infected with the virus up to 14 days following exposure. But researchers say most illnesses begin five to seven days after COVID-19 exposure.A close contact is considered someone who is within 6 feet of someone with the virus for a period of 15 minutes or more over the course of a day. 1626

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