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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 founder of the Women's March is calling for the movement's current co-chairs to step down for allowing bigotry into their mission.Teresa Shook, a lawyer and educator who founded the Women's March movement, accused the group's current co-chairs -- Bob Bland, Tamika Mallory, Linda Sarsour and Carmen Perez -- of associating with bigoted outside groups and tarnishing the Women's March's initial goals in a post on her Facebook page Monday.The co-chairs "have steered the Movement away from its true course. I have waited, hoping they would right the ship," Shook wrote. "But they have not. In opposition to our Unity Principles, they have allowed anti-Semitism, anti-LBGTQIA sentiment and hateful, racist rhetoric to become a part of the platform by their refusal to separate themselves from groups that espouse these racist, hateful beliefs.""I call for the current Co-Chairs to step down and to let others lead who can restore faith in the Movement and its original intent," Shook added. "I stand in Solidarity with all the Sister March Organizations, to bring the Movement back to its authentic purpose."The Women's March leaders swiftly shot back, crediting Shook for "creating a Facebook event named the Million Women's March" and lambasting her for not working to support the movement's ongoing growth."Today, Teresa Shook weighed in, irresponsibly, as have other organizations attempting in this moment to take advantage of our growing pains to try and fracture our network," the Women's March wrote in a post on its Facebook page. "Groups that have benefited from our work but refuse to organize in accordance with our Unity Principles clearly have no interest in building the world our principles envision. They have not done the work to mobilize women from diverse backgrounds across the nation.""Our ongoing work speaks for itself. That's our focus, not armchair critiques from those who want to take credit for our labor," the statement continued.The 2019 Women's March is slated for January, two years after the initial march that followed President Donald Trump's inauguration, and inspired countless sister marches nationwide.Shook's critique comes following longstanding criticism of the group's association with Louis Farrakhan, the leader of the black nationalist group Nation of Islam, who has made numerous anti-Semitic and homophobic comments.Mallory and Perez have both posted photos on Instagram of themselves with Farrakhan praising the National of Islam leader, and Sarsour spoke at the Justice or Else rally headlined by Farrakhan in 2015. Mallory, an African-American leader of the Women's March and anti-gun violence activist, attended a large event in February where Farrakhan stated that "the powerful Jews are my enemy."Mallory declined to denounce Farrakhan after the event. The Women's March released a statement emphasizing that Farrakhan's statements were "not aligned with the Women's March Unity Principles" and that "our external silence has been because we are holding these conversations and are trying to intentionally break the cycles that pit our communities against each other."Sarsour said that following the shooting at the Tree of Life synagogue in Pittsburgh, critics suddenly called on the Women's March to denounce Farrakhan."There was nothing new that happened between Women's March and the Minister," Sarsour wrote in an online essay. "Folks decided to rehash 8 months ago."MPower Change, a Muslim organization that Sarsour co-founded, helped raise over 0,000 to cover the funeral expenses for the Tree of Life victims"This is not a letter in defense of Minister Farrakhan," she added. "He can do that for himself. We have been CRYSTAL CLEAR in BOTH of our statements that we REJECT antisemitism and all forms of racism. We have been CLEAR that Minister Farrakhan has said hateful and hurtful things and that he does not align with our Unity Principles of the Women's March that were created by Women of Color."A week before the Tree of Life shooting, Farrakhan made public anti-Semitic remarks, saying, "I'm not an anti-Semite. I'm anti-Termite." 4113

The FBI continues to investgate reports of a #jetpack near #LAX on 8/30. Anyone with info about activity on or above the ground at the location depicted here should call the FBI. The FBI takes seriously events that threaten US airspace & investigates alleged violations #SafeSkies pic.twitter.com/dLZcZeRDuc— FBI Los Angeles (@FBILosAngeles) September 4, 2020 377

The current day trading boom will end as these frenzies always do: in tears. While we wait for the inevitable crash, let’s review not only why day traders are doomed but also why most people shouldn’t trade, or even invest in, individual stocks.Day trading basically means rapidly buying and selling investments, hoping to profit from small price fluctuations. Brokerages have reported a surge in trading and new accounts this year, starting with March’s stock market crash when investors rushed in looking for bargains. As pandemic lockdowns kept people from their jobs and classrooms, trading continued to soar, especially among young adults.The poster child for this gold rush is Robinhood, a commission-free investing app that uses behavioral nudges to encourage people to trade. Robinhood added over 3 million accounts this year and in June logged more trades than any of the established, publicly traded brokerages. More than half of its customers are opening their first investment account, the company says.People can start trading with small amounts of money because Robinhood offers fractional shares. In addition to stocks and mutual funds, the app allows trading in options, cryptocurrencies and gold. Customers start out with a margin account, which allows them to borrow money to trade and amplify both their gains and their losses.Alexander Kearns, 20, is one example of what can go wrong. The University of Nebraska student killed himself after seeing a 0,165 negative balance in his Robinhood account. The novice trader may have misunderstood a potential loss on part of an options tradethat he made using borrowed money as a loss on the whole transaction. In reality, he had ,000 cash in his account when he died.Research has shown that the vast majority of day traders lose money, and only about 1% consistently get better returns than a low-cost index fund. A rising stock market, and a flood of inexperienced and excitable investors willing to bid up stock prices, has convinced more than a few day traders that they’re part of that 1%. They’re being egged on by the few people who actually will make money: the hucksters selling seminars, e-books and strategies that purport to teach you how to successfully trade.Stocks don’t always go upStocks overall are an excellent way to gain wealth over the long term. If you can weather the downturns, stocks historically have offered good returns.Those downturns can be doozies, however. Stocks lost half their value during the Great Recession that started December 2007. The market lost nearly 90% of its value in the early years of the Great Depression.Extended downturns have popped previous day trading bubbles, including the one that formed during the dot-com boom. The Nasdaq composite stock index rose 400% in five years, only to lose all of those gains from March 2000 to October 2002.Markets that go down eventually come back up. That’s not true of individual stocks. Any single stock can lose value, sometimes all the way to zero, and never recover.The sensible way to hedge that risk is diversification. That means buying stocks in many, many companies, including companies of different sizes, in different industries and in different countries. That’s prohibitively expensive for most individual investors, which is why mutual funds and exchange-traded funds are a better bet.There’s no such thing as a free tradeAnother way to grow wealth is to minimize investing costs. That means trading less, not more, because trading incurs costs even when there are no commissions involved.Investments held more than a year benefit from favorable capital gains tax rates, for example. Those held less than a year are taxed as income if the trade wasn’t made in a tax-deferred account such as an IRA.Another way cost is incurred is in what’s known as the bid/ask spread. The banks and financial institutions that facilitate trading in various stocks are called market makers. They offer to sell stocks at a certain price (the ask price) and will purchase at a slightly lower price (the bid price). People who trade stocks instantly lose a little money on each transaction because of this difference. That’s not a big deal for infrequent traders, but the costs add up if you churn stocks in and out of your portfolio.The biggest potential cost, though, is that every trade exposes your portfolio to the many ways we humans have of screwing up our money. We’re loss-averse and we want to avoid regret, so we hang on to losing stocks. We think that we can predict the future or that it will reflect the recent past, when this year should have taught us that we can’t and it won’t.We also think we know more than we do, a cognitive bias known as overconfidence. If you’re determined to trade, or day trade, don’t gamble more than you can afford to lose, because you almost certainly will.This article was written by NerdWallet and was originally published by the Associated Press.More From NerdWalletSuddenly Retired? Here’s What to Do NextSmart Money Podcast: Sudden Retirement and Finding Lost MoneyYou Can Use a Crisis to Build Helpful Money HabitsLiz Weston is a writer at NerdWallet. Email: lweston@nerdwallet.com. Twitter: @lizweston. 5216

The coronavirus pandemic pumped up bicycle sales to the point that buyers confronted the first bicycle shortage in the U.S. since the 1970s. In tandem with that sales surge, bicycle theft has soared in a number of U.S. cities.As you might expect, the rise in bike ownership and theft has prompted more Americans to ponder insurance coverage for bicycles. That’s a particularly valid concern, since more than 2 million bikes are stolen each year in North America, according to Project 529. Pedal along as we examine the numerous spokes of bicycle insurance.How Are Bicycles Insured?Bicycles are covered under the personal property section of a standard homeowners or renters insurance policy. An insurer will reimburse you, minus your deductible, if you file a claim when your bike is stolen or when it’s damaged in a fire or other disaster that’s covered by your policy.Furthermore, homeowners and renters policies offer financial protection (under liability insurance) if you injure somebody or damage someone else’s property when you’re riding your bike.If your bike is damaged because you fall off or you collide with a tree, pedestrian or curb, it won’t be covered by your homeowners or renters insurance unless you add it separately to your policy. This is known as “scheduling” an individual item.If you’re riding your bike and are injured in a crash with a vehicle, your auto insurance policy would generally cover your medical bills under either personal injury protection or medical payments coverage, assuming you have one of those.Snejina Zacharia, founder and CEO of insurance marketplace Insurify, further notes that homeowners or renters insurance usually doesn’t cover a bike (or any of your possessions, for that matter) if it’s damaged or destroyed in a flood, earthquake or landslide.What Kind of Coverage Do I Need if I Own an Expensive Bike?The Insurance Information Institute suggests that if you own an expensive bike, you should ask about an add-on to homeowners or renters insurance known as an endorsement to boost your coverage. You also can explore a standalone bike insurance policy.Bike insurance policies usually provide broader and deeper coverage than homeowners or renters insurance policies do. For example, Markel’s bike insurance can cover things like crash damage, roadside assistance, spare parts and replacement-bike rentals, whereas a typical homeowners or renters insurance does not.Markel and another bike insurer, Velosurance, say their annual premiums start at 0. Markel’s average bike insurance policy costs 0 to 0 a year.Trusted Choice, a network of independent insurance agents, says you should look into standalone bike insurance if:You spent a lot of money on your bike. An everyday bike might cost roughly 0 to 0, while a specialty bike might go for more than ,000.You frequently ride off-road, potentially placing you and your bike at greater risk for harm.You compete at cycling events.You own a bike that’s been specially designed, upgraded or modified.You lack homeowners or renters insurance.You don’t have health insurance to cover injuries you might suffer in a cycling crash.Should You File a Claim if Your Bike Is Stolen or Damaged?If your bike is worth 0 but your homeowners or renters policy carries a 0 deductible, Zacharia recommends against filing a claim.“Not only will a claim increase your monthly premiums, but you won’t be getting anything in return. Essentially, it’s a lose-lose situation,” she says.If your bike is worth more than the deductible, calculate your potential claim check amount. If it’s small, it still probably isn’t worth filing a claim and risking a rate increase in the future that could cost you more over time.“It’s really about the balance between the cost of replacement and the increased cost on your monthly premiums. Some people might also say the hassle of making a claim is an additional downside,” says Zacharia.“Remember that your deductible matters,” Zacharia adds. “If your bicycle is worth 0 but your deductible is set at ,000, you’ll be paying out of pocket to replace it. It’s up to you where you set a deductible level. Just be prepared for the bill.”Registering Your BikeOne way to discourage bike theft—or at least have a better chance of getting your stolen bike back—is to engrave a serial number on it and register the number with the local police department. For example, New York City offers a bicycle registration program. 4472