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SAN DIEGO (AP) — An appeals court on Wednesday upheld a freeze on Pentagon money to build a border wall with Mexico, casting doubt on President Donald Trump's ability to make good on a signature campaign promise before the 2020 election.A divided three-judge panel of the 9th U.S. Circuit Court of Appeals in San Francisco agreed with a lower court ruling that prevented the government from tapping Defense Department counterdrug money to build high-priority sections of wall in Arizona and New Mexico.The decision is a setback for Trump's ambitious plans. He ended a 35-day government shutdown in February after Congress gave him far less than he wanted. He then declared a national emergency that the White House said would free billions of dollars from the Pentagon.The case may still be considered, but the administration cannot build during the legal challenge.A freeze imposed by U.S. District Judge Haywood Gilliam Jr. of Oakland in May prevented work on two Pentagon-funded wall contracts — one spanning 46 miles (74 kilometers) in New Mexico and another covering 5 miles (8 kilometers) in Yuma, Arizona.While the order applied only to those first-in-line projects, Gilliam made clear that he felt the American Civil Liberties Union and other groups were likely to prevail at trial in their argument that the president was ignoring Congress' wishes by diverting Defense Department money."Congress's 'absolute' control over federal expenditures — even when that control may frustrate the desires of the Executive Branch regarding initiatives it views as important — is not a bug in our constitutional system. It is a feature of that system, and an essential one," the judge wrote.Gilliam went a step further Friday by ruling definitively that the administration couldn't use Pentagon counterdrug money for the two projects covered in his May order or to replace 63 miles (101 kilometers) in the Border Patrol's Tucson, Arizona, sector and 15 miles (24 kilometers) in its El Centro, California, sector.Trump immediately vowed to appeal.At stake is billions of dollars that would allow Trump to make progress on a major 2016 campaign promise heading into his race for a second term.Trump declared a national emergency after losing a fight with the Democratic-led House that led to the 35-day shutdown. Congress agreed to spend nearly .4 billion on barriers in Texas' Rio Grande Valley, the busiest corridor for illegal crossings, which was well below the .7 billion the president requested.Trump grudgingly accepted the money but declared the emergency to siphon money from other government accounts, finding up to .1 billion for wall construction. The money includes .6 billion from military construction funds, .5 billion from Defense Department counterdrug activities and 0 million from the Treasury Department's asset forfeiture fund.Acting Defense Secretary Mark Esper has yet to approve transferring the military construction funds. The Treasury Department funds have so far survived legal challenges.The president's adversaries say the emergency declaration was an illegal attempt to ignore Congress. The ACLU sued on behalf of the Sierra Club and the Southern Border Communities Coalition.The administration said the U.S. needed emergency protection to fight drug smuggling. Its arguments did not mention illegal immigration or unprecedented numbers of Central American families seeking asylum at the U.S. border, which have dominated public attention in recent months.Justice Department attorneys argued that the freeze on Pentagon funds showed a "fundamental misunderstanding of the federal appropriations process.""The real separation-of-powers concern is the district court's intrusion into the budgeting process," they wrote.The two sides argued before a three-judge panel in San Francisco on June 20, made up of Barack Obama appointee Michelle Friedland and George W. Bush appointees N. Randy Smith and Richard Clifton.The administration has awarded .8 billion in contracts for barriers covering 247 miles (390 kilometers), with all but 17 miles (27 kilometers) of that to replace existing barriers not expand coverage. It is preparing for a flurry of construction that the president is already celebrating at campaign-style rallies.Trump inherited barriers spanning 654 miles (1,046 kilometers), or about one-third of the border with Mexico. Of the miles covered under Trump-awarded contracts, more than half is with Pentagon money.The Army Corps of Engineers recently announced several large Pentagon-funded contacts.SLSCO Ltd. of Galveston, Texas, won a 9 million award to replace the New Mexico barrier. Southwest Valley Constructors of Albuquerque, New Mexico, won a 6 million award for the work in Tucson. Barnard Construction Co. of Bozeman, Montana, won a 1.8 million contract to replace barrier in Yuma and El Centro. 4877

SAN DIEGO (CNS) - A distraught man driving a van stolen in Sorrento Valley led San Diego police and the California Highway Patrol on a lengthy chase Thursday that ended in Riverside County, authorities said.San Diego Police Department Officer Scott Lockwood said the white van was stolen from the 9400 block of Scranton Road about 10:45 a.m.SDPD officers pursued the stolen vehicle through Mira Mesa, and the CHP took over the chase when the driver got onto northbound Interstate 15. The suspect, who's in his 50s, was apprehended just south of Weirick Road in Corona at 11:54 a.m., according to the CHP."The suspect was suicidal and inflicted harm to himself, possibly with a sharp-edged knife or razor," CHP Officer Javier Muniz said.Muniz said the unidentified suspect was transported by ambulance to Inland Valley Hospital for treatment. 849

San Diegans living in their cars and recreational vehicles rallied Wednesday against a new city law that places steep restrictions on where they can stay.The City Council passed the emergency restriction in May after residents complained about safety concerns with people living in their cars.The law bans people from living in their vehicles near homes or schools, and blocks them from staying almost everywhere in the city between 9 p.m. and 6 a.m."Homeless could by anybody, it doesn't mean we're criminals," said Robert Ewing, who lives in his R.V. "Just because we ain't got no place to stay. Times are hard."The law went into effect in June, about the same time the city opened a new safe parking lot for R.V's next to SDCCU Stadium in Mission Valley. The lot, however, has largely gone unused. People who live in their vehicles describe concerns over gas mileage, location and a rule requiring them to be out by 7 a.m.Meanwhile, Disability Rights California is challenging the ordinance in court. A spokeswoman for the mayor says the city is committed to providing individuals living out of their vehicles a safe place to park at night, while connecting them to supportive services.At the same time, she says the city is committed to keeping its neighborhoods clean and safe. 1291

SAN DIEGO — Small business owners across San Diego County are about to put in for their share of a 5 billion pot of forgivable federal loans.That’s because a new round of Paycheck Protection Program loans is part of the new stimulus package, to help small businesses make it through the pandemic.“Obviously, we have major restrictions on us and visits are down probably more than ever right now,” said Cat Kom, owner of Studio Sweat in Rancho Bernardo.Even moving the exercise bikes outside was a struggle for the gym. Kom got stuck in the elevator for more than an hour before fire rescue crews got her out.But she finally sees some help on the way - in the new stimulus package.“As long as they do their best and it's moral and the funding goes to the small businesses that really need it, and loopholes aren’t exploited, then that's the best that we can hope for,” she said.The first round did not go smoothly. In fact, major corporations like Shake Shack got the maximum million, and paid it back after public outcry,.This time, however, there are protections against that.Eligibility is limited to companies with up to 300 employees, down from 500 in the first round. Loans are capped at million, down from million, and companies must show revenue down 25 percent in at least one quarter - compared to the same quarter a year earlier.“Congress doesn't want a P.R. nightmare and I think they want to try to help the people that need it but not dump taxpayers money into big business that's doing just fine,” said Kelly DuFord Williams, managing partner at Slate Law Group.Small businesses have been waiting for that help for months.Once the stimulus package becomes law, small businesses can apply for the loans through their banks. 1758

SAN DIEGO (CNN) - Two years ago, Brendan Tyne pleaded with the Food and Drug Administration to approve a drug that he was hopeful could finally bring his mother some peace.She could no longer move without assistance and had fallen victim to the debilitating and frightening psychosis that haunts many people with Parkinson's disease."She thinks there are people in the house and animals are trying to get her," he told an FDA advisory committee.He believed that a new medication called Nuplazid, made by San Diego-based Acadia Pharmaceuticals, was the answer.Nuplazid's review was being expedited because it had been designated a "breakthrough therapy" -- meaning that it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market. Congress created this designation in 2012 in an effort to speed up the FDA's approval process, which has long been criticized for being too slow. Around 200 drugs have been granted this designation since its creation.Still, to recommend approval, the advisory committee would have to find that the drug's potential benefits outweighed its risks for its intended patients.Some FDA officials concluded that Nuplazid's public health benefit was enough to merit approval of the drug. Their argument echoed the pleas of family members and caregivers like Tyne: It could possibly help patients with no other alternative. Several of the people who spoke said their loved ones had been transformed during the clinical trials, though some said there was no way for them to know whether they were on Nuplazid or a placebo.But the physician who led the FDA's medical review, Dr. Paul Andreason, 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. The company's limited testing, he said, had not convinced him that the benefits outweighed the risks.While Tyne had heard about these risks, he said he "discounted death as a real statistical possibility" and was willing to try anything to help his mother."I have two young children who love their grandmother," he told the committee. "If nothing is done to bring her back to some semblance of normalcy, my children will never remember their grandmother for who she is: a loving, funny, caring woman who has improved the lives of all of the loved ones who surround her. Please, I beg you, do not deprive my children and their grandmother of experiencing that love."The committee voted 12-2 and recommended that the FDA approve Nuplazid for the treatment of Parkinson's disease psychosis based on a six-week study of about 200 patients. Three previous studies of the drug did not show that it was effective, Andreason said in his medical review, though they showed similar risk.Even some committee members who voted in favor of the drug expressed reservations, according to the hearing transcript. "I guess I'm hoping that the risks are going to be small, and I think the benefits for some of these people who are very sick and whose families are affected by this, I think they're probably willing to take that risk," one physician stated. Another committee member said she wouldn't have voted for the drug's approval if there had been a safe and effective alternative on the market. A third made a "plea" to the FDA to "consider a large observational study so we can ensure that, once it goes into real-world use, that the benefits will outweigh the risks."It hit the market in June 2016. As caregivers and family members rushed to get their loved ones on it, sales climbed to roughly 5 million in 2017.Tyne got his mother on the drug as soon as it became available. But after trying it for months, he says he was devastated to see that it was doing nothing to halt the awful progression of the disease, and her hallucinations became more frequent and harder to manage. "She has gone straight downhill to the point she really can't function at all," he said.Shortly after the drug's release, 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. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.Creatures like cats and snakes can haunt patients with Parkinson's disease psychosis, as shown in Acadia's TV commercial.In November, an analysis released by a nonprofit health care organization, the Institute for Safe Medication Practices, warned that 244 deaths had been reported to the FDA between the drug's launch and March 2017. The organization also noted that hundreds of reports suggested the drug was "not providing the expected benefit" or potentially worsening the condition.Tracked by the FDA, these so-called "adverse event reports" document deaths, side effects and other issues, and can be made directly by consumers, caregivers and other medical professionals. Reports are submitted to either the FDA or to the drugmaker, which is required to pass along any it receives to the federal government. In some cases, the person filing the report is convinced the side effects were caused by the drug; in others, the reporter ascribes no cause but notes that the patient was on the drug.An adverse event report does not mean that a suspected medication has been ruled the cause of harm and is typically not the result of an official investigation. 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 or pulling it off the market.After analyzing the adverse event data for Nuplazid, the Institute for Safe Medication Practices concluded that this batch of reports "reinforces the concerns of those who warned that (Nuplazid) might do more harm than good." Thomas Moore, senior scientist for drug safety and policy for the nonprofit, said the deaths are an "important warning signal" and warrant further review by the FDA -- and possible action, depending on what the review finds.Since the institute released its analysis, FDA data shows that the number of reported deaths has risen to more than 700. As of last June, Nuplazid was the only medication listed as "suspect" in at least 500 of the death reports.Physicians, medical researchers and other experts told CNN that they worried that the drug had been approved too quickly, based on too little evidence that it was safe or effective. And given these mounting reports of deaths, they say that more needs to be done to assess Nuplazid's true risks."This is almost unheard of, to have this many deaths reported," said Diana Zuckerman, founder and president of the nonprofit thinktank the National Center for Health Research, adding that because reports are voluntary, potential problems may be underreported. "You just don't see this with most new drugs -- you don't see all these reports -- so you have to take it seriously."Acadia and the FDA maintain that the medication's potential benefits continue to outweigh the risks and help fill a desperate need. Psychosis affects up to 50% of the roughly one million Americans suffering from Parkinson's disease, according to the FDA, and Nuplazid is the first drug to be approved to treat this specific condition.Acadia said there are a number of reasons for the higher volume of death reports. Parkinson's disease psychosis is more commonly seen in patients in the most advanced stages of the disease, meaning they are already at a high risk of death. Plus, the company distributes Nuplazid through a network of specialty pharmacies that allow them to be in more frequent contact with both patients and caregivers -- meaning it is more likely to receive reports of death, which it is required to pass along to the FDA."If you are actively and regularly engaging patients and/or caregivers, it is inevitable that you will see a higher number of adverse events reported, especially in an older, chronically ill patient population," the company said in a statement.It said its "benefit/risk assessment of Nuplazid remains unchanged," and it carefully monitors and regularly analyzes safety reports from both ongoing studies and adverse event reports. The company noted, for example, that since the drug's approval, two studies of a total of more than 300 patients with Alzheimer's disease did not find a difference in the number of deaths reported between Nuplazid and the placebo.The company also provided CNN with a statement from Dr. Joseph Jankovic, professor of neurology and an expert on movement disorders at Baylor College of Medicine. "I have accumulated a great deal of experience with this drug," Jankovic said in the statement. "While not all patients are completely satisfied, many of my patients have experienced marked improvement in their visual hallucinations, paranoia and other psychotic symptoms."In an interview this week, FDA commissioner Scott Gottlieb was asked by CNN's Dr. Sanjay Gupta about his thoughts on drugs that receive expedited reviews and then prompt concerns about safety once they become available, like Nuplazid. While Gottlieb didn't want to comment on a specific product, he said he is "familiar with the circumstances" and that it's very important for the agency to make sure it is "appropriately balancing" safety with medical need. He said this is a flexible standard, however, and there may be more tolerance for risk in situations where there is a significant need and patients don't have an alternative."You've seen us take regulatory action recently in the post-market setting to limit the use of drugs when new safety concerns became known," he said.The FDA told CNN it will continue to monitor the adverse event reports and review the drug's safety. It added that Nuplazid's "complex safety profile," recognized at the time of its approval, resulted in a requirement that the medication carry a number of warnings on its label so that doctors could analyze potential risks and benefits before prescribing the drug.The cases reported so far, according to the FDA, typically involved elderly patients with advanced-stage Parkinson's disease who suffer from numerous medical conditions and often take other medications that can increase the risk of death."Based on these data, the FDA has, at this time, not identified a specific safety issue that is not already adequately described in the product labeling," the agency said in a statement.The FDA has required antipsychotics to carry its most severe "black box" warning for the treatment of elderly dementia patients, after studies found that the medications increase the risk of death in this population. Between 50% and 80% of Parkinson's patients experience dementia as the disease worsens, according to the Alzheimer's Association. Because Nuplazid is a new kind of antipsychotic that targets a different receptor in the brain, its maker claims it comes with fewer toxic side effects. Even so, Nuplazid also carries a black box warning.Geriatric psychiatrist and former FDA medical officer Susan Molchan said that the number of deaths is alarming and questioned whether patients and their families are aware of the risks associated with the drug.To determine the true risks of Nuplazid, the researchers interviewed by CNN said, the FDA needs to require further scientific studies -- and not just rely on the reports, which are challenging to interpret and are not systematically collected. They also worried that, because the drug was already approved, these studies and any action by the FDA could take years.A CNN review of several hundred adverse event reports shows that the detail provided for each case varies widely and that thorough investigations are rarely conducted -- making it difficult to determine whether Nuplazid might have been involved in the deaths of already sick and elderly patients.In these reports, the physicians who prescribed the drug sometimes suggest that their patients likely died from complications from Parkinson's rather than because of Nuplazid. In other cases, it's unclear when exactly the patient started or stopped taking the medication. And in yet others, family members and sometimes doctors are convinced the drug contributed to the deaths.One report recounts the death of a 73-year-old woman in a long-term care facility who was taking Nuplazid. Just before 8 in the morning, a nurse noted that the woman was "sleepy." Shortly after, she was found unresponsive and without a pulse. Paramedics were not able to revive her and, less than an hour after the nurse's visit, she was pronounced dead. While her physician didn't believe her death was "related" to Nuplazid, her husband was convinced that it had played a role and paid for an autopsy. It showed only that she had pre-existing heart issues and died of cardiac arrest.In another report, an 89-year-old man was taken off the drug after experiencing a significant decline. His doctor blamed Nuplazid for his deteriorating condition. The patient died weeks later. In a third report, a woman flagged her husband's death to the FDA after he was taken to the hospital due to dehydration. After he passed away, she said, she was told by "someone at the hospital" that the death was connected to his use of Nuplazid.Acadia said it analyzed these reports and concluded that there "is nothing to suggest a causal relationship to Nuplazid." Acadia calculated a mortality rate for Nuplazid, which it said was lower than what you'd see in the general population of Parkinson's disease psychosis patients covered by Medicare. It calculated this using deaths reported to the FDA and what it considered a conservative estimate of patients on the drug, along with Medicare claims data. However, multiple experts interviewed by CNN said that this is an unreliable calculation since it is comparing apples to oranges.In the weeks after the Institute for Safe Medication Practices issued its report on the deaths, Acadia's stock price dropped by more than 20%. While many large investors remain bullish about the stock, some investment analysts have made public records requests to the FDA for the death reports.Currently, Nuplazid can cost nearly 0 a day, according to wholesale pricing data from First Databank. That can add up to more than ,000 a year for a single patient, though the amount a patient actually pays depends on factors including individual insurance coverage.Acadia expects sales of Nuplazid to at least double this year.Acadia's TV commercial shows how frightening Parkinson's disease psychosis can be.The company, meanwhile, is forging ahead with clinical trials in an attempt to get the medication approved for use in a larger patient population: patients who have dementia-related psychosis. In October, the FDA granted its coveted breakthrough designation for this potential use as well, meaning it will also undergo a speedier review process.While a doctor can legally prescribe a drug for any reason, insurance companies may not approve it for uses that are not FDA-approved. So FDA approval to treat dementia patients would likely result in Nuplazid being prescribed to a much wider population, concerned medical experts told CNN."You would certainly hope they don't approve it for anything else," said Zuckerman of the National Center for Health Research, based on the current research and FDA adverse event reports. "If they're going to approve it for another group of patients that is much, much larger -- that would be unconscionable."That is something they should absolutely not do given these unanswered questions about risk."Roughly two years have passed since that FDA meeting, where family members and caregivers -- some of whom traveled there on Acadia's dime -- gathered with medical experts to debate the merits and potential risks of Nuplazid.Andreason, the physician who led the FDA's medical review of Nuplazid, no longer works for the agency.He said that while he stands by the warnings he made at the time, he understands that other antipsychotics used to treat Parkinson's patients also come with an increased risk of death and that, when patients have a debilitating disease like Parkinson's, physicians and caregivers may choose a medication that improves quality of life even if it could also shorten life expectancy.He said that he was not surprised to hear about the reports of death."This is exactly what I thought was going to happen," he said. "We were going to get a burst of reports of serious adverse events and deaths."Dr. Stephanie Fox-Rawlings, a senior fellow at the National Center for Health Research who spoke against the drug's approval at the FDA committee meeting, recently told CNN she understands how desperate families in these situations are, but she does not think Nuplazid is the answer based on her review of Acadia's public research. She and Zuckerman said that, after previous studies didn't show it was effective, the drugmaker changed the way the medication's ability to improve psychosis was measured, which resulted in a positive outcome. Acadia said its studies have had different objectives and all of them have used "consistent, appropriate, and validated assessment methodology.""If patients know there is some level of benefit, they can judge their risk," said Fox-Rawlings. "But if we don't even know that it does work, how do you even judge that? It's kind of a false hope."Kim Witczak was the consumer representative on the FDA committee evaluating Nuplazid. She and the patient representative were the only two members to vote against its approval. She still can't believe it's on the market."I remember leaving really, really frustrated," she said.CNN reached two of the three family members who petitioned for Nuplazid's approval at the meeting, despite having had no experience with the drug or its clinical trials, to ask whether they tried the medication once it hit the market.One of these was Elaine Casavant. Despite the "staggering cost" of the medication, she said, she was quick to get her husband on it. But after three months, he showed no improvement and they stopped the medication. She has heard success stories, however, and remains optimistic that the drug could be helping certain people.The other person was Tyne.The 43-year-old New Jersey resident works in New York and visits his mother every weekend at a nursing home in the Bronx. Tyne has attempted to move on from the disappointment of Nuplazid, but he still gets frustrated talking about it."Knowing what I know now -- that it didn't work at all -- I wouldn't have gotten my hopes up," he said.But he doesn't regret trying."If there was something that could possibly help my mom and I didn't do it, I wouldn't be able to look at myself in the mirror." 18971