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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 Democratic National Convention featured a video on Tuesday highlighting the friendship between former Senate colleagues John McCain and Joe BidenThe video featured Cindy McCain, Sen. McCain’s widow.“My husband and Vice President Biden enjoyed a 30+ year friendship dating back to before their years serving together in the Senate, so I was honored to accept the invitation from the Biden campaign to participate in a video celebrating their relationship,” Cindy McCain tweeted.The Biden-McCain relationship has been well documented over the years.In 2017, following Sen. McCain’s brain cancer diagnosis, Biden appeared on ABC’s “The View,” which is co-hosted by the senator’s daughter Meghan McCain. The segment was emotional, as Biden discussed how he lost his son Beau in 2015 from the same type of cancer that ultimately killed Sen. McCain.McCain died in August 2018 from brain cancer.The Democratic Party has used the convention to paint Biden as a bipartisan candidate who can attract moderate Republicans. On Night 1 of the convention, Democrats featured former Ohio Gov. John Kasich among other Republicans to display their support for Biden.While McCain was once the standard bearer for the Republican Party, his influence in the party dwindled in his later years. In 2017, shortly after his cancer diagnosis, McCain joined just two other GOP senators in striking down legislation that would have repealed parts of the Affordable Care Act. McCain’s vote drew scorn from Republican leaders including President Donald Trump.The frosty relationship between Trump and McCain became evident following McCain’s death, when he opted in his will not to invite Trump to his funeral, but extended invitations to former Presidents Bill Clinton, George W. Bush and Barack Obama. 1786

The Flores family has been farming dates for three generations.For the past few years, Marco Flores, owner of San Marcos Date Farm, says he’s seen major changes in temperature and weather patterns.“It’s drier than it used to be,” he said of the land his father bought in California’s Coachella Valley more than 55 years ago. “It used to be a lot more moist before.”These are conditions his 300 fruit-producing palm trees don’t like.“Sometimes there’s no rain,” Flores said. “The impact of climate change is definitely doing something to them.”Similar concerns are being expressed across the planet.“Climate change is impacting agriculture and farmers abilities,” said Paul Minehart of the Syngenta Group, a global agricultural innovation company.Minehart’s team recently published a study showing 72% of farmers they interviewed from around the world are worried about climate changes impacting crop yields.“It’s coming down to, especially in the United States, is the unpredictable weather patterns that are beginning to emerge,” he said.Minehart says those unpredictable weather patterns include unusual droughts and flooding in America and extremely arid conditions in other countries. Conditions that could impact farmers production and profits.“If you have fewer crops than the price could go up,” he said. “That could impact the overall cost of producing food and then at the consumer level buying the food.”Marco Juarez is the third generation of Flores farmers at San Marcos Date Farm.He says while using more water could cause his family to raise their prices from a pound for dates, there’s another growing concern: getting skilled workers to take a job in this heat.“I don’t think anyone really wants to work in this,” he said. “It slowly drives people away. I mean, who wants to be here in 120 degrees?” 1826

The county of San Diego is preparing to ask the state for nearly million to repave stretches of hundreds of roads it maintains.The Board of Supervisors could vote Wednesday to seek revenue from the recent gas-tax hike to repair the roads. The roads are in all ends of the county, from Bonita to Alpine to Vista. You can see a list of the roads here (it starts on page 3)."The proposed projects will improve the overall condition of the roads and will protect roads from deterioration and costly future repairs," a county staff report said. Gov. Jerry Brown signed the billion gas tax hike into law last year. Californians already pay a series of gas taxes ranking among the highest in the nation. The tax hike raised the per-gallon tax by 12 cents last November, with future increases planned. The bill, SB1, also added a 0 fee to the annual registration for electric vehicles, starting with model year 2020."People can't afford it. I'm retired but if you're working and have to commute, I don't think people realize how much of a dent that's going to make," said Vicky Bamburger, a Bonita resident who is supporting an effort to repeal the tax that appears to be headed to this November's ballot.But those who support the increase say fixing the roads will save California drivers from expensive car repairs due to problems like potholes, and save taxpayers from larger repairs later."A small improvement now - if you have a road that needs to be covered - that's going to be so much more cost effective, cost saving in the long run," said Catherine Hill, of the League of California Cities.Local governments have until May 1 to submit their gas-tax revenue road repair requests to the state. Still, county agencies have already received millions of dollars in new revenue for road repairs, which includes major improvements to Interstate 5 in North County.  1892

The Collective Brewing project has teamed up with Lone Star Taps and Caps in Fort Worth, Texas to turn Easter's most polarizing treat—Marshmallow Peeps—into a craft beer. They plan to tap the concoction Friday, March 30 at 6 p.m. at the Taproom in Fort Worth, and they're calling the collaboration "Peep this Collab."On the website, the taste is described as tart and lemon-y and the look is described as a glitter bomb with fabulous sparkle. However, Ryan Deyo, Collective Brewing's head brewer and co-founder said drinkers could expect a "lightly tart" and marshmallow-y" taste from the beer on guidelive.Regardless of the flavor, Deyo said they mashed 30 boxes of peeps into a beer brewed with sour ale, vanilla and butterfly pea flowers (yes, actual flowers). If that doesn't sound delicious already, the beer will have purple tint thanks to the pea flowers and they will have edible glitter to up the sparkle content. This whole idea is a part of Deyo's passion to make beer for more fun."I've been on a kick to assert beer should be a fun thing," Deyo told guidelive. "We make a beer with ramen noodles, so Peeps isn't really a stretch."If Ramen Noodle beer sound just as good as peep beer, you're in luck, but neither of those flavors top the wackiest ever made by craft brewers. Flavors like Rocky Mountain Oyster, Oyster, Coconut Curry and Pizza beer have turned heads in the past.  1439