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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 CDC appears to be making slight changes to who should be tested for coronavirus for a second time this week, after their changes on Monday sparked confusion and reaction from the scientific community.On Monday, the CDC updated their website to read that testing is no longer recommended for symptom-less people who were within 6 feet of an infected person for more than 15 minutes.This set off a wave of confusion about who should be tested and the reason for the change. All questions were directed to the CDC’s parent organization, the Department of Health and Human Services.In a statement distributed to media Thursday, CDC Director Robert Redfield said those who come in contact with a confirmed or probable COVID-19 patient(s) could be tested, even if they don’t show symptoms, according to TheHill.com.“Testing is meant to drive actions and achieve specific public health objectives. Everyone who needs a COVID-19 test, can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action,” Redfield said in the statement.The New York Times reports the guidelines are not changed on the Centers for Disease Control and Prevention’s website, and appears unlikely the agency will change them. 1326

The FBI has fired Peter Strzok, an agent who was removed from the Russia probe last year for sending text messages disparaging President Donald Trump, Strzok's lawyer said Monday.Aitan Goelman, Strzok's attorney, said FBI Deputy Director David Bowdich ordered the agent's termination on Friday. Goelman said that the deputy director's decision comes after the head of the office that normally handles disciplinary actions decided Strzok should instead face a demotion and 60-day suspension."The decision to fire Special Agent Strzok is not only a departure from typical Bureau practice, but also contradicts (FBI) Director (Christopher) Wray's testimony to Congress and his assurances that the FBI intended to follow its regular process in this and all personnel matters," Goelman said in his statement.The FBI declined to comment on Goelman's assertions.Strzok played a lead role in the investigation into Hillary Clinton's private email server and was involved in the FBI's recommendation that no criminal charges be filed against the former secretary of state. He later helped oversee the beginnings of the probe into Russian meddling in the 2016 election, and his involvement in both investigations has been seized on by Republicans as evidence of anti-Trump bias in the bureau and those investigating potential coordination between the Trump campaign and Moscow.The President tweeted about the firing Monday afternoon, calling Strzok a "total fraud" and repeated his claim that there was no collusion nor that he obstructed justice."Agent Peter Strzok was just fired from the FBI - finally. The list of bad players in the FBI & DOJ gets longer & longer. Based on the fact that Strzok was in charge of the Witch Hunt, will it be dropped? It is a total Hoax. No Collusion, No Obstruction - I just fight back!" Trump wrote, adding in another tweet, "Just fired Agent Strzok, formerly of the FBI, was in charge of the Crooked Hillary Clinton sham investigation. It was a total fraud on the American public and should be properly redone!"Because Strzok, who is 48, was fired before his 50th birthday, he potentially stands to lose a portion of his pension benefits.His firing was earlier reported by The Washington Post. 2236

The country’s top infectious disease expert is standing by his prediction that even if a COVID-19 vaccine is available by the end of this year, Americans should not expect a return to normalcy until late next year.Dr. Anthony Fauci’s latest comments come in an interview with MSNBC Friday in which he says, “If you're talking about getting back to a degree of normality which resembles where we were prior to covid, it's going to be toward the middle of 2021, maybe even end of 2021.”These statements come as more states are relaxing social distancing and lockdown measures; opening more theaters, gyms, salons and indoor dining.Dr. Fauci, who is the director of the National Institute for Allergy and Infectious Diseases, remains confident a vaccine will be available by the end of the year. However, he says just because it’s available doesn’t mean a quick return to pre-COVID life."But by the time you mobilize the distribution of the vaccine and get a majority or more of the population vaccinated and protected, that’s likely not going to happen until the end of 2021," Dr. Fauci told host Andrea Mitchell.He also expressed concern about states reopening certain indoor activities, because of the increased risk of contracting COVID-19. 1249

The Ebola virus outbreak in the Democratic Republic of Congo has killed 33 people, the World Health Organization said Sunday.An additional 43 suspected cases of Ebola were reported, including 13 confirmed by lab testing, according to WHO.The outbreak is spreading through five health zones in North Kivu province and one health zone in Ituri province, which poses geographic and political challenges, the WHO said. North Kivu borders Rwanda and Uganda and trade activity fuels heavy movement across the borders.North Kivu also hosts over 1 million displaced people and fighting between government forces and armed militant groups makes containing the highly infectious virus a challenge. 695

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