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The Centers for Disease Control and Prevention is set to shorten the recommended length of quarantine after exposure to someone positive for COVID-19, as the virus rages across the nation.According to a senior administration official, the new guidelines, which are set to be released as soon as Tuesday evening, will allow people who have come in contact with someone infected with the virus to resume normal activity after 10 days, or 7 days if they receive a negative test result.That's down from the 14 days recommended since the onset of the pandemic.According to the Associated Press, the agency adjusted its guidance in July by shortening it from 14 days to 10.The agency presented the new guidance during a White House coronavirus task force meeting on Tuesday for final approval, the AP reported. 812
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 Bureau of Transportation Statistics released preliminary data on Monday, which shows U.S. airlines carried almost twice as many passengers in June than in May. According to the news release, BTS said data collected showed that 16.3 million passengers flew on large airlines in June, up from 8.4 million on all U.S. airlines in May.The BTS said airlines carried 80% fewer passengers in June than it did exactly one year ago.The data was by 20 airlines that carry 90% of the passengers, the agency said."June 2020 was the second consecutive month that the annual decrease in the number of U.S. airline passengers was less than annual change in the previous month," BTS reported.According to the agency, preliminary data showed a 77% decline in domestic passengers between June 2019 to June 2020 following more substantial annual reductions in May (88%) and April (96%).Preliminary data showed that international passengers on U.S. airlines declined 96% from June 2019 to June 2020, following annual decreases of 99% in April and 98% in May, the agency said.BTS says final U.S. airline traffic reports for June will be released on Sept. 11. International data by origin and destination, which is under a six-month confidentiality restriction, will be released on Dec. 10, the agency said. 1297
The CIA has determined that Saudi Crown Prince Mohammed bin Salman personally ordered the killing of journalist Jamal Khashoggi, despite the Saudi government's denials that the de facto ruler was involved, according to a Washington Post report.Citing people familiar with the matter, the Post reported Friday that the CIA reached its conclusion by examining several sources of intelligence. According to the Post, US officials have high confidence in the CIA's assessment.A spokesman for the CIA declined to comment to the Post. The Saudi government has denied bin Salman's involvement in Khashoggi's death.Fatimah Baeshen, a spokeswoman for the Saudi Embassy in Washington, told the newspaper that the claims in the CIA's "purported assessment are false.""We have and continue to hear various theories without seeing the primary basis for these speculations," she told the Post.Khashoggi, a former Saudi royal insider who became a critic of the country's government, went missing in October after he visited the Saudi consulate in Istanbul to obtain papers for his upcoming marriage. The Saudi government offered changing explanations for Khashoggi's disappearance.Included in the US intelligence analyzed by the CIA was a phone call the prince's brother Khalid bin Salman made to Khashoggi, encouraging the journalist to make the trip to the consulate to get the documents, according to the Post. Sources told the Post that Khalid made the call at his brother's command.Khalid denied the Post's reporting, saying on Twitter that he had never spoken to Khashoggi by phone."I never talked to him by phone and certainly never suggested he go to Turkey for any reason. I ask the US government to release any information regarding this claim," Khalid said.He said the last contact he'd had with Khashoggi was via text in October 2017.Baeshen told the Post that Khalid, who is the Saudi ambassador to the US, and Khashoggi never discussed "anything related to going to Turkey."The CIA also examined an audio recording from inside the Saudi consulate provided by Turkey and a phone call placed from inside the consulate after Khashoggi was killed, according to the Post.Maher Mutreb, an alleged member of the Saudi hit team and a security official for the crown prince, placed the phone call to a top aide for bin Salman informing the aide that the job had been done, people familiar with the call told the newspaper.According to the Post, the CIA also based its conclusion on its evaluation of bin Salman as a leader who is involved in minor matters.The CIA does not know the location of Khashoggi's remains, according to the Post.The Trump administration on Thursday?imposed penalties on 17 individuals over their alleged roles in the killing of Khashoggi. Khashoggi's assassination has created a crisis for the Trump administration and drawn attention to President Donald Trump's business ties to Saudi Arabia and the relationship between bin Salman and Trump's son-in-law and senior adviser, Jared Kushner.Earlier Thursday, the Saudi Public Prosecutor's Office said 11 people had been charged for their involvement in the death of Khashoggi, adding that five are facing capital punishment for being directly involved in "ordering and executing the crime."Khashoggi was killed following "a fight and a quarrel" at the Saudi consulate, the prosecutor's office claimed. Prosecutors said Khashoggi was tied up and injected with an overdose of a sedative that killed him. Then, according to prosecutors, his body was dismembered and removed from the consulate by five people. 3617
The Department of Veteran's Affairs (VA) is facing a huge undertaking as COVID-19 vaccines roll out to the general public.More than 418,000 healthcare workers and 10 million patients will eventually get the COVID-19 vaccine through the VA.The department received 73,000 doses of Pfizer's COVID-19 vaccine this week, and residents and staff at long term communities run by the department are first in line to be inoculated.There are about 17,500 veterans living in VA long-term care facilities across the country, and several thousand more work in those centers.The vaccine could not have arrived sooner for those staff members and patients."I know a lot of VA medical centers are going through COVID surges right now, alongside with their communities," said Dr. Jane Kim, the Chief Consultant for Preventive Medicine at the VA.Most vaccines are mandatory for military members. For now, the COVID-19 vaccine is still voluntary. That's likely due to the limited supply of the vaccine and because it's only under Emergency Use Authorization right now.Still, veteran doctors want to reassure their patients."I got the vaccine yesterday," Kim said. "I had a sore arm yesterday, but my arm feels good today. I feel fine today. I would recommend this vaccine to my family and also my patients when it's available for them and it's their turn."More than 5,500 veteran patients and 87 VA staff members have died of COVID-19 since the start of the pandemic. That doesn't include state-run veteran's homes.The VA is not responsible for providing COVID-19 vaccines to those state-run veteran's homes. 1596