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The Dow Jones Industrial just closed above 29,000! You are so lucky to have me as your President??With Joe Hiden’ it would crash??— Donald J. Trump (@realDonaldTrump) September 2, 2020 192
The current spike in COVID-19 cases is stressing the testing system across the country.As the virus spreads at unprecedented rates, more Americans are seeking COVID-19 tests. But in recent days, companies that make the tests and the supplies needed for them are struggling to keep up with demand."Those companies were operating on an allocation basis, and that just means that basically everything they make is going out the door," said Kelly Wroblewski, the Director of Infectious Disease Programs at the Association of Public Health Laboratories. "There is no reserve, so there's an increased demand in a lab for testing. There's no more reagent to be had, so to meet that demand, that lab has to use a different manufacturer's test."Wroblewski adds that along with issues in getting supplies, officials are also short on human resources — there is only so much lab capacity and only so many trained people to conduct the tests.The American Clinical Laboratory Association says the surge in demand for testing means some labs could reach or exceed their current testing capacities soon — meaning it could take longer for patients to get PCR test results back.Wroblewski says that it can take currently take anywhere from 24 hours to a week to get PCR test results back.With antigen tests, patients can get results back in less than 30 minutes. There is currently enough of a supply for antigen tests, but not all facilities offer them.Both lab groups stress that COVID-19 testing is important, but patients should be strategic."There's been a lot of emphasis put on testing, but testing is only one piece of the puzzle," Wroblewski said. "It gives you some information, and if you're not going to do anything with that information — whether it be targeted closures. whether it be staying home and isolating — we're not going to stop the spread of disease."As far as getting more tests, it's going to take a while. Wroblewski says it could take up to six months or more to increase production capacity significantly. Labs don't expect to see a ramp-up in supplies until early 2021. 2090

The calendar just turned to November but some companies are already in the Christmas spirit. Starbucks and McDonald's have already released their 2017 holiday cups.Starbucks scrapped its traditional red design for a DIY cup. There's a stack of presents, a Christmas tree, doves, two people holding hands and lots of white space. Customers are encouraged to color the cups themselves. 412
The election is days away, and ballots across the country are already being cast in person, via mail. Billed as one of the most important elections of our time, ABC 10News D.C. Correspondent Joe St. George joins us to talk about the presidential election, what to watch for in Thursday's dueling town halls, and to explain how Nevada and Arizona could play a major role in deciding our next president.You can join us at 9:30 a.m. for the conversation right here on our ABC 10News Facebook page. 502
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
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