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The death of a missing six-year-old boy with autism whose body was found in a North Carolina creek in September has been classified as a "probable drowning," according to an autopsy report from the Mecklenburg County Medical Examiner.Maddox Ritch went missing while on a walk with his father at a Gastonia park on September 22. In an extensive search, authorities used dogs, drones and sonar, and partially drained an 80-acre lake to better see its shoreline.Maddox's body was found five days later in a creek about a mile east of Rankin Lake Park, where he was last seen with his father and a friend, authorities said."The findings are not inconsistent with drowning," the medical examiner's report said. "In conjunction with investigative information at this time, which gives no indication of other than an accidental drowning, it seems reasonable to conclude that the likely cause of death is drowning."The body was partially submerged in 2 to 3 feet of water. The area, thick with underbrush, had been searched numerous times."We appreciate everyone's patience and support while we worked to uncover every piece of evidence available to bring our death investigation to this conclusion," Gastonia Police Chief Robert Helton said in a statement Thursday, adding that no criminal charges were expected to be filed in connection with the death."I ask for continued prayers for Maddox's family and everyone touched by this child's tragic death."Maddox's father, Ian Ritch, said in late September that he and a friend were walking when his son ran ahead, likely triggered by a passing jogger. Maddox was about 25 to 30 feet away when he broke into a sprint, Ritch said.Ritch said he "was giving him just a little leeway, freedom" but he had a clear view of his son. Maddox often would run ahead but let him catch up, Ritch said."I couldn't catch up with him. I feel guilt for letting him get so far ahead of me before I started running after him," Ritch told reporters.The FBI became involved in the case, with investigators waiting to determine the cause and manner of death, as well as the boy's exact movements. At the time, authorities pleaded for anyone with information to come forward.In an emotional Facebook post after the discovery of his son's body, Ritch wrote: "I had big plans with my son. I wanted us to go fishing play ball go camping. I wanted to be his hero. I wanted him to say I was more than superman or batman to him. I wanted people to ask him who his hero is and him say my daddy. Now I'm no hero I couldn't save him or protect him at all. I would give anything to go back and save him." 2624

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 company that makes Cream of Wheat says it is initiating an immediate review of its brand and packaging as the nation's institutions hold ongoing conversations about race amid weekslong protests."B&G Foods, Inc. today announced that we are initiating an immediate review of the Cream of Wheat brand packaging," the company said in a statement Wednesday. "We understand there are concerns regarding the Chef image, and we are committed to evaluating our packaging and will proactively take steps to ensure that we and our brands do not inadvertently contribute to systemic racism."Cream of Wheat's packaging includes an image of a black chef. In early advertisements, copy refers to the chef as "Rastus" — a term now considered a slur. The name refers to a minstrel show caricature of a stereotypically happy black man.Cream of Wheat follows in the footsteps of Aunt Jemima pancake mix, which announced Wednesday that it would drop its mascot (also rooted in minstrel show tropes) and change its name. Uncle Ben's rice, which also uses a black man's portrait on its packaging, said it planned to "evolve" the brand, but did not offer specifics.Protests against systemic racism and police brutality across the country were sparked by the death of George Floyd, a black man who died in police custody in Minneapolis. Bystander video from Floyd's arrest showed a police officer, later identified as Derek Chauvin, kneeling on Floyd's neck for more than eight minutes. 1478

The former football coach for The Ohio State University, Earle Bruce, died early Friday morning, ESPN reports.Bruce was the coach for the Buckeyes from 1979 to 1987 and had the difficult task of replacing legendary Buckeyes coach Woody Hayes. He was well-regarded, leading the team to four Big Ten titles and had a 5-3 record in bowl games. A number of his players, such as Jim Lachey, Keith Byars and Pepper Johnson, went onto pro careers. 478

The Federal Trade Commission (FTC) is cracking down on glasses and contact prescribers who may try to stop you from shopping around.The FTC sent warning letters to almost 30 different eyeglass prescribers. The letters say the prescriber must give a copy of the prescription to the patient without them asking.They can't charge a special fee for doing that and they can’t force you to buy from them just because they did the examination.“However, there were a lot of prescribers that just weren't doing that,” said Linda Sherry, Director of National Priorities at Consumer Action. “If you asked for it, in most cases, you would get it. They also are required to post notices in the offices to say that you have a right to your prescription and a lot of prescribers we're not posting those notices.”Consumer Action is educating people on their eyeglass and contacts prescription rights. Sherry says prescriptions allow you to go online and to other eyeglass and contact sellers to shop for the best deal.Another thing she says to ask for, especially if you're shopping online, is pupil distance. It may not be on the prescription.“I had an experience where I asked for the pupil distance and was told that would be to put the pupil distance on, so I was like, ‘I've been coming here for three years and you've obviously measured my pupil distance, because I bought glasses from you. So, all you have to do is open your records and tell me my pupil distance.’ And they did do it, but there was that moment there when she said for the pupil distance measurement when I thought, ‘oh, something's very, very wrong here.’”Prescribers shouldn't be charging for that info either.If you're having trouble getting prescription information from your provider, you can contact the FTC. But remember you may also be due for a new eye exam. State laws vary but most eye prescriptions are only good for one year. 1912