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Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market

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by Liz Szabo, KFF News
Thu, 03 Aug 2023 09:00:00 +0000

Hospital toxicologist Ryan Marino has seen up close the violent reactions of children poisoned by liquid nicotine from electronic cigarettes. One young boy who came to his emergency room experienced intense nausea, diarrhea, and vomiting, and needed intravenous fluids to treat his dehydration.

Kids can also become dizzy, lose consciousness, and suffer dangerous drops in blood pressure. In the most severe case he's seen, doctors put another boy on a ventilator in the intensive care unit because he couldn't breathe, said Marino, of Case Western Reserve School of Medicine.

Thousands of kids a year are exposed to the liquid nicotine in e-cigarettes, also known as vapes. For a toddler, even a few drops can be fatal.

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Cases of vaping-related nicotine exposure reported to poison centers hit an all-time high in 2022 — despite a 2016 law, the Child Nicotine Poisoning Prevention Act, that requires child-resistant packaging on bottles of vaping liquid. In what doctors call a major oversight, the doesn't require protective packaging on devices themselves.

Refillable vapes are designed to hold liquid nicotine in a central reservoir, making them dangerous to kids, Marino said. Even vapes that appear more child-resistant — because their nicotine is sealed inside a removable cartridge — present a risk, because the cartridges can be pried open. And some disposable e-cigarettes, now the top-selling type on the market, allow users to take thousands of “puffs” and contain as much nicotine as multiple packs of cigarettes.

Many e-cigarettes and liquids seem designed to appeal to kids, with pastel packages, names such as “Candy King,” and flavors such as bubble gum and blue raspberry. That makes vapes far more tempting — and hazardous — than traditional cigarettes, which have lower doses of nicotine and a bitter that often prompts children to quickly spit them out, said Diane Calello, the executive and medical director of the New Jersey Poison Information and Education System.

“Nicotine liquid is an accident waiting to happen,” Calello said. “It smells good and it's highly concentrated.”

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Sen. Richard Blumenthal (D-Conn.), who co-sponsored the 2016 legislation, said he would push to expand the childproof packaging requirement to disposable and pod-based e-cigarettes.

“Every day that FDA allows flavored e-cigarette products to remain on the market is another day that children can be enticed by these dangerous, and sometimes deadly, products,” he said.

Although the FDA declined to comment for this article, on Aug. 2 the agency included a special feature about nicotine poisoning in children in its “CTP Connect” newsletter.

The number of reports to poison control centers about e-cigarettes has more than doubled since 2018, according to an FDA analysis. Poison control centers reported more than 7,000 vaping-related exposures in people of all ages from April 1, 2022, to March 31, 2023.

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According to the FDA, 43 of those exposures resulted in hospitalization and an additional 582 in other medical treatment. About half of poison center reports had no information about whether needed medical care.

Nearly 90% of exposures involved children under 5. Authors of the say their numbers likely underestimate the problem, given that poison control centers aren't contacted in every case.

A 1-year-old died from vaping-related nicotine poisoning in 2014. The new FDA report also mentions the apparent suicide of an adult via e-cigarette poisoning.

A spokesperson for the vaping industry said companies take safety seriously.

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“All e-liquid bottles manufactured in the United States conform to U.S. law,” said April Meyers, the president of the board of directors and CEO of the Smoke- Alternatives Trade Association, which represents the vaping industry. “Not only are the caps child-resistant, but the flow of liquid is restricted so that only small amounts can be dispensed.”

Yet many vaping products are made outside the U.S., which has recently been flooded with illegal e-cigarettes, mostly from China.

The increasing number of nicotine exposures among kids — especially curious toddlers who put virtually everything they can grab into their mouths — likely reflects the sheer volume of e-cigarette sales, said Natalie Rine, the director of the Central Ohio Poison Center at Nationwide Children's Hospital.

E-cigarette unit sales grew 47% from January 2020 to December 2022, rising from 15.5 million every four weeks to 22.7 million, according to a report published by the Centers for Disease Control and Prevention.

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“This isn't something that parents see as a really big risk,” Marino said. “But with the popularity of e-cigarettes, the risk isn't going away anytime soon.”

One effective strategy to reduce e-cigarette sales has been to ban flavored products. California, , New Jersey, New York, Rhode Island, and Washington, D.C., have banned all flavored e-cigarettes, while Utah and Maryland have banned some flavors. A study showed overall e-cigarette sales dropped 25% to 31% in states after flavor bans, compared with states that didn't ban them.

Some doctors say the country needs to do more to protect children.

“If the numbers are rising, then the law ain't working,” said Carl Baum, a professor of pediatrics and emergency medicine at Yale School of Medicine.

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Pediatrician Gary Smith said the lack of child safety requirements for e-cigarette devices is a major problem. Refillable e-cigarettes are relatively easy for kids to open.

Although most poison control center reports don't include brand information, disposable e-cigarettes — Elfbar, Puff Bar, and Pop Vape — were some of the most common products mentioned in the FDA analysis. Elfbar is now known as EB Design.

Expanding the federal law to include devices would be “an important step,” said Smith, president of the Child Injury Prevention Alliance, an Ohio-based advocacy group that works to prevent injuries in children.

In addition, federal officials should limit the nicotine concentration in vape juices to make them less toxic, as well as ban candy-like flavors and colors on packaging, Smith said.

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“The public health response should be comprehensive,” Smith said.

Kids have been known to pick up a vape and begin puffing, in imitation of their parents, Calello said.

Even if children don't inhale the aerosol, sucking on a vape exposes their skin to nicotine, which can be absorbed into the bloodstream, said Robert Glatter, an assistant professor of emergency medicine at Lenox Hill Hospital in New York City. Glatter noted that e-cigarette liquids also contain numerous harmful chemicals, including arsenic and lead, which is toxic at any dose; carcinogens such as acetaldehyde and formaldehyde; and benzene, a volatile organic compound found in auto exhaust.

Fortunately, children who inhale nicotine get a much lower dose than those who ingest it, reducing the risk of serious harm, said Marc Auerbach, a professor of pediatric emergency medicine at Yale School of Medicine.

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Only about 2% of exposures in the FDA study were recorded as a moderate or major effect.

That may be because little kids who get into dangerous liquids — from vape juice to household cleaning products or gasoline — usually spill most of it, Baum said. “They often end up wearing it rather than swallowing it,” Baum said.

Although Stephen Thornton has seen a lot of children with nicotine exposure, he said, the human body has ways of protecting itself from toxic substances. “Fortunately, when kids do ingest these e-cig nicotine products, they self-decontaminate. They vomit — a lot — and this keeps the mortality rate very low, but these kids still often end up in emergency departments due to all the nausea and vomiting,” said Thornton, an emergency medicine physician and medical director of the Kansas Poison Control Center.

The FDA urges parents and guardians of young children to keep e-cigarettes and vaping liquid out of reach and in its original container.

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For emergency assistance, call Poison Help at 800-222-1222 to speak with a poison expert, or visit poisonhelp.org for support and resources.

By: Liz Szabo, KFF Health News
Title: Doctors Sound Alarm About Child Nicotine Poisoning as Vapes Flood the US Market
Sourced From: kffhealthnews.org/news/article/child-nicotine-poisonings-surge-electronic-cigarettes-vapes/
Published Date: Thu, 03 Aug 2023 09:00:00 +0000

Kaiser Health News

Exclusive: Senator Urges Biden Administration To Thwart Fraudulent Obamacare Enrollments

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Julie Appleby, KFF Health News
Tue, 21 May 2024 15:45:00 +0000

Stronger actions are needed immediately to thwart insurance brokers who fraudulently enroll or switch people in Affordable Care Act coverage, Sen. Ron Wyden, chairman of the powerful Senate Finance Committee, said Monday.

“We want the Centers for Medicare & Medicaid Services to hold these brokers criminally responsible for ripping people off this way,” he told KFF Health News.

In a sharply worded letter sent to CMS Administrator Chiquita Brooks-LaSure, the Oregon Democrat expressed “outrage” over the practice, which nets unscrupulous agents commission payments while leaving consumers with a potential host of problems, from losing access to their regular doctors or treatments to higher deductibles and even owing taxes.

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Noting that tens of thousands of Americans have been victimized, Wyden called on regulators to step up enforcement and be more proactive in notifying potentially affected consumers. He vowed to introduce legislation that would make participating in such schemes subject to criminal penalties.

“CMS must do more and you must do it now,” he wrote in his letter.

Complaints about such unauthorized enrollment schemes have grown in recent months. KFF Health News has reported that unscrupulous brokers or agents can easily access policyholder information to change their coverage through private commercial platforms integrated with the federal Obamacare marketplace, healthcare.gov, which serves 32 states.

The challenge for federal regulators is to thwart the activity without reducing enrollment — a top priority for 's administration.

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CMS, which oversees the federal website, said it's working on regulatory and technological fixes and can suspend or terminate problem agents' access to healthcare.gov.

The agency will respond directly to Wyden, said Jeff Wu, acting director of CMS' Center for Consumer Information & Insurance Oversight, in a written statement. He further noted that the agency is “consistently evaluating opportunities to identify and resolve issues sooner, through outreach, technical assistance, and compliance actions.”

Ronnell Nolan, president and of Health Agents for America, whose group has been outspoken about the need for regulators to do more, welcomed Wyden's involvement and the potential for criminal penalties for perpetrators.

“It's a when a person's insurance is taken from them when they're in the middle of cancer treatment or on a transplant list and they're put in a predicament where they might lose their because of the fraudulent activity,” she said.

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After initially declining to quantify the problem, CMS this month issued a statement saying it had received more than 90,000 complaints in the first quarter of 2024 about unauthorized enrollments and plan switches. While the number of complaints represents a small percentage of the more than 16 million enrollments processed through healthcare.gov for this year's coverage, it may understate the breadth of the problem, as complaints likely don't reflect the magnitude of cases.

Although Wyden lauded CMS' efforts to fix problems already encountered by consumers, he said in his letter that the agency needs to be more proactive about preventing them.

He urged regulators to contact potentially affected consumers instead of waiting to investigate only after a policyholder files a complaint, which sometimes doesn't occur until weeks or months after a plan is switched.

It can be difficult for victims to recognize the changes. Rogue agents don't obtain their consent, and many are signed up for plans that have no monthly premiums, so they don't get a bill. Other consumers unknowingly enroll when they respond to misleading marketing promising gift cards, “ subsidies,” or other financial .

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Rather than wait for a consumer to complain, regulators could reach out directly when they see a policy submitted or changed by a broker or agency that has been found to be fraudulently enrolling others, Wyden wrote.

Wyden also said CMS should use its authority to impose civil penalties, up to $250,000, against “brokers who submit fraudulent enrollments.”

“I am disappointed these penalties have not yet been used to hold bad actors accountable,” he wrote.

Finally, he wants the agency to private-sector platforms used by agents and brokers to enroll consumers in ACA plans. Those private companies are not used by 18 states and the District of Columbia, which their own ACA marketplaces. The state-run marketplaces impose additional layers of identity-proofing and other security measures and have reported far fewer problems with unauthorized enrollment.

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Dozens of private “enhanced direct enrollment” entities are certified by CMS to integrate with healthcare.gov. Their involvement was expanded during the Trump administration, which also sharply reduced for nonprofits to help with outreach and enrollment.

The platforms were designed to be simpler to use than healthcare.gov. But they have drawn criticism from agents, who say the private websites make it too easy for unscrupulous brokers or others to access policyholder information and make changes. Currently, more than half of federal marketplace enrollments are assisted by agents or brokers, and most act legitimately, regulators and others say.

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By: Julie Appleby, KFF Health News
Title: Exclusive: Senator Urges Biden Administration To Thwart Fraudulent Obamacare Enrollments
Sourced From: kffhealthnews.org/news/article/aca-enrollment-fraud-senator-ron-wyden-urges-biden-administration-crackdown/
Published Date: Tue, 21 May 2024 15:45:00 +0000

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High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment

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Renuka Rayasam
Tue, 21 May 2024 09:00:00 +0000

For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill their prescriptions for the medications they need to control their blood sugar.

Without Ozempic or a similar drug, Cooper Harris suffers blackouts, becomes too tired to watch her grandchildren, and struggles to earn extra money braiding hair. Marcus Harris, who works as a Waffle House cook, needs Trulicity to keep his legs and feet from swelling and bruising.

The 's doctor has tried prescribing similar , which mimic a hormone that suppresses appetite and controls blood sugar by boosting insulin production. But those, too, are often out of stock. Other times, their insurance through the Affordable Care Act marketplace burdens the couple with a lengthy approval or an out-of-pocket cost they can't afford.

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“It's like, I'm having to jump through hoops to live,” said Cooper Harris, 46, a resident of Covington, Georgia, east of Atlanta.

Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy.

One root of the problem is the very high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was “difficult” to afford, according to KFF poll results released this month. But it is with the lowest disposable incomes who are being hit the hardest. These are people with few resources who struggle to see and buy healthy foods.

In the United States, Novo Nordisk charges about $1,000 for a month's supply of Ozempic, and Eli Lilly charges a similar amount for Mounjaro. Prices for a month's supply of different GLP-1 drugs range from $936 to $1,349 before insurance coverage, according to the Peterson-KFF Health System Tracker. Medicare spending for three popular diabetes and weight loss drugs — Ozempic, Rybelsus, and Mounjaro — reached $5.7 billion in 2022, up from $57 million in 2018, according to research by KFF.

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The “outrageously high” price has “the potential to bankrupt Medicare, , and our entire health care system,” Sen. Bernie Sanders (I-Vt.), who chairs the U.S. Senate Committee on Health, Education, Labor and Pensions, wrote in a letter to Novo Nordisk in April.

The high prices also mean that not everyone who needs the drugs can get them. “They're kind of disadvantaged in multiple ways already and this is just one more way,” said Wedad Rahman, an endocrinologist with Piedmont in Conyers, Georgia. Many of Rahman's patients, including Cooper Harris, are underserved, have high-deductible health plans, or are on public assistance programs like Medicaid or Medicare.

Many drugmakers have programs that help patients get started and stay on medicines for little or no cost. But those programs have not been reliable for medicines like Ozempic and Trulicity because of the supply shortages. And many insurers' requirements that patients prior authorization or first try less expensive drugs add to delays in care.

By the time many of Rahman's patients see her, their diabetes has gone unmanaged for years and they're suffering from severe complications like foot wounds or blindness. “And that's the end of the road,” Rahman said. “I have to pick something else that's more affordable and isn't as good for them.”

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GLP-1 agonists — the category of drugs that includes Ozempic, Trulicity, and Mounjaro — were first approved to treat diabetes. In the last three years, the Food and Drug Administration has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand to skyrocket. And demand is only growing as more of the drugs' benefits become apparent.

In March, the FDA approved the weight loss drug Wegovy, a version of Ozempic, to treat heart problems, which will likely increase demand, and spending. Up to 30 million Americans, or 9% of the U.S. population, are expected to be on a GLP-1 agonist by 2030, the financial services company J.P. Morgan estimated.

As more patients try to get prescriptions for GLP-1 agonists, drugmakers struggle to make enough doses.

Eli Lilly is urging people to avoid using its drug Mounjaro for cosmetic weight loss to ensure enough supplies for people with medical conditions. But the drugs' popularity continues to grow despite side effects such as nausea and constipation, driven by their effectiveness and celebrity endorsements. In March, Oprah Winfrey released an hourlong special on the medicines' ability to help with weight loss.

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It can seem like everyone in the world is taking this class of medication, said Jody Dushay, an assistant professor of medicine at Harvard Medical School and an endocrinologist at Beth Israel Deaconess Medical Center. “But it's kind of not as many people as you think,” she said. “There just isn't any.”

Even when the drugs are in stock, insurers are clamping down, leaving patients and health care providers to navigate a thicket of ever-changing coverage rules. Medicaid plans vary in their coverage of the drugs for weight loss. Medicare won't cover the drugs if they are prescribed for obesity. And commercial insurers are tightening access due to the drugs' cost.

Health care providers are cobbling together care plans based on what's available and what patients can afford. For example, Cooper Harris' insurer covers Trulicity but not Ozempic, which she said she prefers because it has fewer side effects. When her pharmacy was out of Trulicity, she had to rely more on insulin instead of switching to Ozempic, Rahman said.

One day in March, Brandi Addison, an endocrinologist in Corpus Christi, , had to adjust the prescriptions for all 18 of the patients she saw because of issues with drug availability and cost, she said. One patient, insured through a teacher retirement health plan with a high deductible, couldn't afford to be on a GLP-1 agonist, Addison said.

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“Until she reaches that deductible, that's just not a medication she can use,” Addison said. Instead, she put her patient on insulin, whose price is capped at a fraction of the cost of Ozempic, but which doesn't have the same benefits.

“Those patients who have a fixed income are going to be our more vulnerable patients,” Addison said.

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By: Renuka Rayasam
Title: High Price of Popular Diabetes Drugs Deprives Low-Income People of Effective Treatment
Sourced From: kffhealthnews.org/news/article/high-prices-ozempic-mounjaro-wegovy-glp1s/
Published Date: Tue, 21 May 2024 09:00:00 +0000

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Biden Leans Into Health Care, Asking Voters To Trust Him Over Trump

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Phil Galewitz, KFF Health News
Tue, 21 May 2024 09:00:00 +0000

Angling to tap into strong support for the sweeping health he helped pass 14 years ago, one of 's latest reelection strategies is to remind voters that former tried to repeal the Affordable Care Act.

“Folks, he's coming for your , and we're not going to let it happen,” Biden says of Trump in a television and digital ad out this month, part of a $14 million investment in the handful of states expected to decide the presidency in November.

The new draws on the popularity of the ACA among independent voters and alludes to Biden's edge over Trump on health issues, which the current president hopes will help propel him to victory.

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Swaying even a tiny percentage of voters could make a difference for Biden, said Kenneth Miller, an assistant professor of political science at the of Nevada-Las Vegas.

“It will be so close,” he said. “Any little thing can be a deciding factor.”

Political experts say Biden is wise to draw attention to the ACA, which ended long-standing insurance practices denying coverage to people with preexisting conditions or charging them more — a change that is “popular across the partisan divide” and benefits about half of U.S. households, said Ashley Kirzinger, KFF's associate director of public opinion and survey research.

“Framing the ACA around those protections is a very smart move,” she said.

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A new KFF survey found Biden has an edge with independent voters when it comes to health care issues.

Independents trust Biden more than Trump to ensure access to affordable health insurance (47% to 22%) and maintain protections for people with preexisting conditions (47% to 23%).

Biden holds a smaller advantage over Trump in whom independents trust more to address high health care costs (39% to 26%). The survey also found the issue isn't a slam dunk for either candidate: About a third of independent voters said they trust neither Biden nor Trump to address costs.

Democrats are fighting to extend higher government subsidies for most people with ACA coverage, which were increased during the pandemic and are set to expire in 2025. They're also banking on outrage over the Supreme Court's 2022 decision striking down , and strict abortion bans that have followed in many Republican-led states, to juice Democratic turnout.

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The stakes “could not be higher for Americans who rely on the Affordable Care Act,” Biden campaign spokesperson Michael Tyler told reporters on a call this month.

The Trump campaign did not respond to a request for comment.

At least one Democratic-aligned super PAC is also running health-related ads, including on Trump's appointment of Supreme Court justices who helped overturn the constitutional right to an abortion.

Barry Burden, director of the Elections Research Center at the University of Wisconsin-Madison, said focusing on health care plays to Biden's strengths.

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“Biden has been mired by voter concerns about inflation and immigration, where Republicans are preferred,” he said. “Health care is more favorable territory where the Trump campaign does not have much of a defense to offer.”

Some recent polls have shown Trump leading in most battleground states, with voters expressing pessimism about the economy.

But Trump is vulnerable on health care, Miller said. He unsuccessfully tried to repeal the ACA as president and has alluded to trying again if he returns to the White House. In November, he declared “Obamacare Sucks!” on social , and in March he said he wants to improve the law without saying how.

“These ads are an effort to shake up the agenda,” Miller said. “Biden needs more work reminding Democrat-leaning independent voters who probably voted for him in 2020 that he is the better choice.”

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Biden's ad also claims his health care policies have helped save Americans $800 a year. The Biden administration has said that's how much 13 million people buying coverage on ACA insurance marketplaces saved in 2022.

The ad's primary claim, that 100 million people would be harmed if Trump eliminated preexisting protections, is misleading, said Robert Speel, director of the Public Policy Initiative at Penn Behrend. That's because many would retain the protections under their coverage, particularly those on Medicare and employer-sponsored insurance.

“The ad looks too generic to have a significant impact on the outcome of the election, though it may get through to enough of the small universe of swing voters to have at least some potential impact on who wins Pennsylvania,” Speel said.

The KFF survey of 1,243 registered voters conducted April 23-May 1 had a margin of sampling error of plus or minus 4 percentage points.

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By: Phil Galewitz, KFF Health News
Title: Biden Leans Into Health Care, Asking Voters To Trust Him Over Trump
Sourced From: kffhealthnews.org/news/article/biden-health-care-ad-buy-obamacare-aca/
Published Date: Tue, 21 May 2024 09:00:00 +0000

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