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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 Christian evangelist who attempted to convert one of the world's last remaining isolated tribes wrote of his convictions in pursuing the mission even in the face of open hostility and attempts on his life, according to diary entries and notes.In excerpts from his journal, John Allen Chau, the American who is believed to have been killed by members of the isolationist Sentinelese tribe on a tiny, remote island in the Bay of Bengal, wrote of returning to the island to continue his attempts at conversion even after a tribesman shot at him with a bow and arrow, piercing a Bible he was carrying."I hollered, 'My name is John, I love you and Jesus loves you,'" he wrote in his diary, pages of which were shared by his mother with the Washington Post. Shortly after, a young member of the tribe shot at him, according to his account.In pages left with the fishermen who facilitated his trip to the island, his musings are a clear indication of his desire to convert the tribe."Lord, is this island Satan's last stronghold where none have heard or even had the chance to hear your name?" he wrote.His notes indicate that he knew the trip was illegal, describing how the small fishing vessel transported him to the isolated island under cover of darkness, evading patrols."God Himself was hiding us from the Coast Guard and many patrols," he wrote.All seven locals who facilitated the trip have been arrested. 1419

The death of a 22-year-old African-American man shortly after a struggle with police last week has been ruled a homicide, authorities in Jefferson Parish, Louisiana said Monday.Keeven Robinson, of Metairie, died last Thursday, following a police chase and an altercation with narcotics detectives from the Jefferson Parish Sheriff's Office, located outside of New Orleans, according to authorities.An initial autopsy found significant traumatic injuries to the soft tissue of Robinson's neck, said Jefferson Parish Coroner Dr. Gerry Cvitanovich, who cautioned that the results from the autopsy, which was conducted Saturday, are preliminary and more tests need to be conducted.Cvitanovich said the findings are consistent with compressional asphyxia, which will likely be cause of death at the end of the process.The four detectives involved in the incident are white, said Sheriff Joseph P. Lopinto, who declined to release their names at this point."I understand ... this investigation will be under a microscope, understand it fully," Lopinto told reporters.Gaylor Spiller, president of the West Jefferson Parish NAACP branch, said Robinson's family is also seeking a second independent autopsy."I like the fact that Sheriff Lopinto stepped up to plate, and he's doing his part," Spiller said, according CNN affiliate WDSU. "He knows that the NAACP will be on his trail."Robinson was being investigated by narcotics detectives early Thursday, Lt. Jason Rivarde, spokesman for Jefferson Parish Sheriff's Office, told CNN.Undercover detectives assigned to the case tracked Robinson down at a local gas station and tried to arrest him, according to Rivarde. But Robinson jumped back in his vehicle and led police on a chase after spotting them, Rivarde said.The suspect rammed several police cars before crashing his vehicle, according to Rivarde.Robinson took off on foot, jumping several fences before deputies caught him in a backyard of a nearby residential neighborhood, Rivarde said.Rivarde says a struggle ensued with deputies who eventually handcuffed Robinson. Once handcuffed, detectives noticed Robinson was not breathing, Rivarde said. Detectives administered life saving techniques before Robinson was taken to a local hospital where he died, Rivarde said.The agency is not equipped with body cameras or dash cameras, according to Rivarde."They were in a struggle," Lopinto said. "They used force." He added that the officers admitted to using force during the arrest.But the sheriff said he's "not coming to the conclusion that this was a chokehold."Lopinto said he contacted the Louisiana State Police on Saturday after he was told of the initial findings, and asked them to assist in the investigation.The sheriff said he has "every faith" in his officers to do their job well."I know they have the expertise because this is what they do every day, but I also understand that an independent set of eyes is something that's appropriate in a case like this," he said.The four detectives involved in the arrest were read their rights and have given statements, Lopinto said.They are being reassigned to administrative duty pending the outcome of the investigation, the sheriff's said.The FBI's Civil Rights Task force is also looking into the matter after he contacted them Saturday, the sheriff said.The actions of the coroner's office were largely praised Monday by Robinson's family.Hester Hilliard, an attorney for Robinson's family, thanked the coroner's office "for their professionalism and their transparency.""Today is just as hard as Thursday for this family. They're grieving, and today they had to find out that Keeven lost his life at the hands of another," she said, according DSU. "And that's very, very hard for them.""Now, it's time for us to move on to making funeral arrangements for a 22-year-old that should not have died," she said.In an interview with CNN, Hilliard said she is hoping "to see the same justice for Keeven as with any other individual who has died at the hands of someone other than the police.""We are hoping for a thorough investigation, an arrest and prosecution of those that caused his death unjustifiably," she said. 4201

The Centers for Disease Control and Prevention is investigating a multi-state outbreak of campylobacter infections linked to contact with puppies sold through Petland, a national pet store chain.Campylobacteriosis, a common bacterial infection, can cause diarrhea, abdominal pain and fever, according to the CDC.As of Sept. 11, a total of 39 people have fallen ill in seven states, including 11 cases in Florida, five in Kansas, one in Missouri, 18 in Ohio, two in Pennsylvania, one in Tennessee and one in Wisconsin. There have been nine hospitalizations and no deaths reported. The first case within this outbreak occurred on September 15, 2016.Symptoms, which typically begin within two to five days after contact with the bacteria, last around a week, though some people don't experience any signs of illness.While many cases go unreported, about 14 cases for every 100,000 people are diagnosed each year in the United States, according to the CDC. Overall, campylobacteriosis -- which occurs much more frequently in the summer months than in the winter -- is estimated to affect over 1.3 million persons every year.Almost every patient recovers within five days without treatment, though drinking extra fluids is recommended. In rare cases, an infection can lead to complications, including paralysis and even death.People with weakened immune systems, such as infants, the elderly and people with cancer or other severe illnesses, are most at risk for a serious infection.People sickened in the current outbreak range in age from younger than 1 year to 64 years old.Most -- 28 of the 39 -- are female and 12 are Petland employees. Of the total, 27 either recently purchased a puppy at Petland, visited a Petland, or visited or live in a home with a puppy sold through Petland."The CDC has not identified any failures of Petland's operating system that would lead to any campylobacter infection," Elizabeth Kunzelman, a spokeswoman for the company, said in an email. "Last week the CDC advised Petland to 'continue to do what we are already doing' and to continue to educate customers and staff to sanitize their hands after handling our puppies."The CDC noted that no matter where a puppy comes from, it may carry a campylobacter infection. Petland is cooperating with the investigation, the government agency said.Kunzelman added that Petland has many sanitation stations in each store and has strict kennel sanitation procedures and protocols put in place by consulting veterinarians."Our extensive health warranty protects both our pets and our customers from bacterial, viral and congenital issues," she said.Most people become infected with campylobacteriosis through eating raw or undercooked poultry. Most infections are singular and not part of an outbreak.By contrast, outbreaks of campylobacteriosis are often linked to unpasteurized dairy products, contaminated water, poultry and produce. Sometimes, though, people get sick after coming into contact with the stool of an ill dog or cat.To avoid contamination from your pet, CDC recommends you wash your hands thoroughly after touching dogs, their poop, or their food. Extra care is needed so that children playing with puppies also wash their hands carefully. Pick up and dispose dog poop carefully, especially in areas where children might play. Finally, you need to contact your veterinarian if you see signs of illness in your puppy or dog.While puppies and dogs with a campylobacter infection might have diarrhea, vomiting, or a fever, just like humans, they also sometimes show no signs of illness.The investigation is ongoing, according to the CDC, which is working with the US Department of Agriculture's Animal and Plant Inspection Service, and several health departments. 3761

The CDC announced Friday a pilot project intended on decreasing chronic diseases in high-risk communities. The government is putting million toward the project to address five areas of social detriments.Some groups—including racial and ethnic minorities, those living in poverty, and people in certain parts of the country—are disproportionately impacted by the burden of chronic conditions, the CDC said.“Chronic diseases touch every American, in one way or another,” said Karen Hacker, M.D., M.P.H., director of CDC’s NCCDPHP. “This important pilot project will help us better understand strategies to advance health equity and reduce the immense burden of chronic disease.”The program will address five areas on concern, said the CDC:Built environment: human-made surroundings that influence overall community health and individual behaviors that drive healthCommunity-clinical linkages: connections made among health care systems and services, public health agencies, and community-based organizations to improve population healthFood insecurity: an economic and social condition characterized by limited or uncertain access to adequate and nutritious foodSocial connectedness: the degree to which individuals or groups of individuals have and perceive a desired number, quality, and diversity of relationships that create a sense of belonging and being cared for, valued, and supportedTobacco-free policy: population-based preventive measures to reduce tobacco use and tobacco-related morbidity and mortality.The CDC said it will work with the Association of State and Territorial Health Officials and the National Association of County and City Health Officials to identify community to join the pilot program. 1727

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