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2025-06-06 15:27:15
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  中山痔疮 屁股疼   

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

  中山痔疮 屁股疼   

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

  中山痔疮 屁股疼   

The Department of Justice is suing to block California laws that extend protections for immigrants living in the United States illegally, commonly referred to as "sanctuary laws."The lawsuit by the Trump administration claims three of the state's laws intentionally undermine federal immigration law, according to The Associated Press.One of the laws prevents local police agencies from asking people about their immigration status or assisting in federal immigration enforcement activities. The Justice Department says these laws are unconstitutional.Attorney General Jeff Sessions, speaking at a law enforcement event in Sacramento Wednesday, said the administration's lawsuit against California was to "invalidate these unjust immigration laws" because the state's laws are a "violation of common sense."Sessions told those in attendance at the California Peace Officers Association's Legislative Day that the state has "a problem" and told California officials to "stop actively obstructing law enforcement … stop protecting lawbreakers."The attorney general singled out Oakland Mayor Libby Schaaf, who recently issued a public warning of an impending immigration raid in her city. Sessions claims that Immigration and Customs Enforcement officers "failed to make 800 arrests" because of Schaaf's statements. 1320

  

The classified ads website Backpage.com has been seized by federal law enforcement agencies, according to a banner that popped up on the site Friday.The banner says, "backpage.com and affiliated websites have been seized as part of an enforcement action" by the FBI, US Postal Inspection Service and the IRS Criminal Investigation Division.Lawmakers on Capitol Hill and advocacy groups have long called for an investigation into Backpage.com for allegedly facilitating prostitution and sex trafficking.A spokesperson for the Justice Department confirmed to CNN that the website has been seized and that additional information would be made available Friday evening. However, a judge decided that the federal case should remain sealed on Friday night. No other additional information was provided.A two-year Senate investigation into online sex trafficking found that found that Backpage.com knowingly aided criminal sex trafficking of women and young girls, simply scrubbing terms from ads such as "Lolita," "teenage," "rape," "amber alert," and publishing them on its site. After the investigation was published in January 2017, Backpage.com shut down its adult ads section.The company has been targeted with several lawsuits over the years, but has been largely protected by Section 230 of the 1996 Communications Decency Act, a legal protection that gives a broad layer of immunity to online companies from being held liable for user-generated content. Companies are supposed to act in good faith to protect users, but critics argue the law can be used as a shield. The law, however, does not, protect sites from federal liability against criminal law, like child-pornography laws.Last month, however, the Senate approved bipartisan legislation called the Stop Enabling Sex Traffickers Act. The legislation would create an exception to Section 230, which would pave the way for victims of sex trafficking to hold websites accountable for facilitating abuse.Two days after the Senate approval, Backpage competitor Craigslist removed its personal ads section.The-CNN-Wire 2080

  

The COVID-19 pandemic has hit people of color particularly hard, and one new study says that may be because of racial disparities in treating high blood pressure.According to the American Heart Association's Scientific Sessions, one-third of disparities in treatment may be the result of racial inequalities in prescribing or increasing the dosage of new medications used in treating high blood pressure.The study found that blood pressure control rates are lower in Black patients compared to other racial groups. Black patients also had more missed opportunities for treatment and missed more clinic appointments."A doctor might think a patient is less likely less able to afford medications, and because of that, they choose to not prescribe a certain medication," said Dr. Valy Fontil, an assistant professor of medicine at UCSF and one of the researchers involved in the study. "Or, they might know this person doesn't have transportation to the clinic, and so sometimes it might even be well-intentioned."Fontil says more standardized treatment protocols would help eliminate the disparities and prevent missed opportunities to get someone the medication they need."Sometimes people present, and the main thing that they're there for is not for the blood pressure," he said. "So, the clinician just sort of kind of might ignore the blood pressure. So automating these sort of standardized treatments would tell the clinician that they — even if the patient's not here for blood pressure — you have to address it in some way."Previous studies have also shown Black patients have more apprehension about why someone is giving them more medication. Fontil says one solution is having the patient be part of the treatment decision making.Fontil adds that the increasing number of virtual visits for blood pressure issues could make the racial disparities even worse. 1876

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