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1st Biden-Trump Debate of 2024: What They Got Wrong, and Right



KFF and PolitiFact staffs
Fri, 28 Jun 2024 15:28:00 +0000

President Joe Biden and former President Donald Trump, the presumptive Democratic and Republican presidential nominees, shared a debate stage June 27 for the first time since 2020, in a confrontation that — because of strict debate rules — managed to avoid the near-constant interruptions that marred their previous encounters.

Biden, who spoke in a raspy voice and often struggled to articulate his arguments, said at one point that his administration “finally beat Medicare.” Trump, meanwhile, repeated numerous falsehoods, including that Democrats want doctors to be able to abort babies after birth.

Trump took credit for the Supreme Court's 2022 decision that upended Roe v. Wade and returned abortion policy to states. “This is what everybody wanted,” he said, adding “it's been a great thing.” Biden's response: “It's been a terrible thing.”

In one notable moment, Trump said he would not repeal FDA approval for medication abortion, used last year in nearly two-thirds of U.S. abortions. Some conservatives have targeted the FDA's more than 20-year-old approval of the drug mifepristone to further restrict access to abortion nationwide.


“The Supreme Court just approved the abortion pill. And I agree with their decision to have done that, and I will not block it,” Trump said. The Supreme Court ruled this month that an alliance of anti-abortion medical groups and doctors lacked standing to challenge the FDA's approval of the drug. The court's ruling, however, did not amount to an approval of the drug.

CNN hosted the debate, which had no audience, at its Atlanta headquarters. CNN anchors Jake Tapper and Dana Bash moderated. The debate format allowed CNN to mute candidates' microphones when it wasn't their turn to speak.

Our PolitiFact partners fact-checked the debate in real time as Biden and Trump clashed on the economy, immigration, and abortion, and revisited discussion of their ages. Biden, 81, has become the oldest sitting U.S. president; if Trump defeats him, he would end his second term at age 82. You can read the full coverage here and excerpts detailing specific -related claims follow:

Biden: “We brought down the price [of] prescription drug[s], which is a major issue for many people, to $15 for an insulin shot, as opposed to $400.”

Half True. Biden touted his efforts to reduce prescription drug costs by referring to the $35 monthly insulin price cap his administration put in place as part of the 2022 Inflation Reduction Act. But he initially flubbed the number during the debate, saying it was lowered to $15. In his closing statement, Biden corrected the amount to $35.


The price of insulin for Medicare enrollees, starting in 2023, dropped to $35 a month, not $15. Drug pricing experts told PolitiFact when it rated a similar claim that most Medicare enrollees were likely not paying a monthly average of $400 before the changes, although because costs vary depending on coverage phases and dosages, some might have paid that much in a given month.

Trump: “I'm the one that got the insulin down for the seniors.”

Mostly False. When he was president, Trump instituted the Part D Senior Savings Model, a program that capped insulin costs at $35 a month for some older Americans in participating drug plans.

But because it was voluntary, only 38% of all Medicare drug plans, including Medicare Advantage plans, participated in 2022, according to KFF. Trump's plan also covered only one form of each dosage and insulin type.

Biden points to the Inflation Reduction Act's mandatory $35 monthly insulin cap as a major achievement. This cap applies to all Medicare prescription plans and expanded to all covered insulin types and dosages. Although Trump's model was a start, it did not have the sweeping reach that Biden's mandatory cap achieved.


Biden: Trump “wants to get rid of the ACA again.”

Half True. In 2016, Trump campaigned on a promise to repeal and replace the Affordable Care Act, or ACA. In the White House, Trump supported a failed effort to do just that. He repeatedly said he would dismantle the health care law in campaign stops and social media posts throughout 2023. In March, however, Trump walked back this stance, writing on his Truth Social platform that he “isn't running to terminate” the ACA but to make it “better” and “less expensive.” Trump hasn't said how he would do this. He has often promised Obamacare replacement plans without ever producing one.

Trump: “The problem [Democrats] have is they're radical, because they will take the life of a child in the eighth month, the ninth month, and even after birth.”

False. Willfully terminating a newborn's life is infanticide and illegal in every U.S. state. 

Most elected Democrats who have spoken publicly about this have said they support abortion under Roe v. Wade's standard, which allowed access up to fetal viability — typically around 24 weeks of pregnancy, when the fetus can survive outside the womb. Many Democrats have also said they support abortions past this point if the treating physician deems it necessary.


Medical experts say situations resulting in fetal death in the third trimester are rare — fewer than 1% of abortions in the U.S. occur after 21 weeks — and typically involve fatal fetal anomalies or life-threatening emergencies affecting the pregnant person. For fetuses with very short life expectancies, doctors may induce labor and offer palliative care. Some families choose this option when facing diagnoses that limit their babies' survival to minutes or days after delivery.

Some Republicans who have made claims similar to Trump's point to Democratic support of the Women's Health Protection Act of 2022, which would have prohibited many state government restrictions on access to abortion, citing the bill's provisions that say providers and patients have the right to perform and receive abortion services without certain limitations or requirements that would impede access. Anti-abortion advocates say the bill, which failed in the Senate by a 49-51 vote, would have created a loophole that eliminated any limits on abortions later in pregnancy.

Alina Salganicoff, director of KFF's Women's Health Policy program, said the legislation would have allowed health providers to perform abortions without obstacles such as waiting periods, medically unnecessary tests and in-person visits, or other restrictions. The bill would have allowed an abortion after viability when, according to the bill, “in the good-faith medical judgment of the treating health care provider, continuation of the pregnancy would pose a risk to the pregnant patient's life or health.”

Trump: “Social Security, he's destroying it, because millions of people are pouring into our country, and they're putting them onto Social Security. They're putting them onto Medicare, Medicaid.”

False. It's wrong to say that immigration will destroy Social Security. Social Security's fiscal challenges stem from a shortage of workers compared with beneficiaries.


Immigration is far from a fiscal fix-all for Social Security's challenges. But having more immigrants in the United States would likely increase the worker-to-beneficiary ratio, potentially for decades, thus extending the program's solvency.

Most immigrants in the U.S. without legal permission are also ineligible for Social Security. However, people who entered the U.S. without authorization and were granted humanitarian parole — temporary permission to stay in the country — for more than one year are eligible for benefits from the program.

Immigrants lacking legal residency in the U.S. are generally ineligible to enroll in federally funded health care coverage such as Medicare and Medicaid. (Some states provide Medicaid coverage under state-funded programs regardless of immigration status. Immigrants are eligible for emergency Medicaid regardless of their legal status.)

By: KFF Health and PolitiFact staffs
Title: 1st Biden-Trump Debate of 2024: What They Got Wrong, and Right
Sourced From: kffhealthnews.org/news/article/biden-trump-2024-presidential-debate-fact-check/
Published Date: Fri, 28 Jun 2024 15:28:00 +0000

Kaiser Health News

Why Millions Are Trying FDA-Authorized Alternatives to Big Pharma’s Weight Loss Drugs



Arthur Allen
Tue, 23 Jul 2024 09:00:00 +0000

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mikhael credits the new class of weight loss drugs. But he isn't using brand-name Wegovy or Zepbound. Mikhael, CEO of Orlando, Florida-based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He's far from alone. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk's Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly's Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The FDA, too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.


But this isn't an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular GLP-1 drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer's disease and drug addiction.

In recent years, the U.S. care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs this year made Novo Nordisk Europe's most valuable company and Lilly the world's biggest pharmaceutical company.

While the companies can't keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”


Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers' semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100 to $450 a month, compared with list prices of roughly $1,000 to $1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 co-inventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven't raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.


“I liken the compounding industry to the airline industry,” Mikhael said. “When you have an airline crash, it hurts everybody.”

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mikhael's company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient's special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.


The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the U.S., Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they're worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don't want a 503B facility to make a copy, it's pretty simple: Don't go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn't specified why it can't keep up with demand, but the bottleneck apparently lies in the company's inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.


The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. The FDA last year issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.

Compounding for Dummies

At least 28 companies mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material's price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some U.S. distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.


Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. Last July, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for three months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta of Manhattan Beach, California. Gupta said he's prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn't seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Gupta said.

There's some risk in using the non-FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can't get it,” he said. “They're constantly triggered by all this food that's causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”


Compounding semaglutide is a helpful sideline for pharmacists like him, Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It's important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA-approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.


The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that's a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

By: Arthur Allen
Title: Why Millions Are Trying FDA-Authorized Alternatives to Big Pharma's Weight Loss Drugs
Sourced From: kffhealthnews.org//article/glp1-compounding-pharmacies-wegovy-zepbound-copycat-drugs-shortages/
Published Date: Tue, 23 Jul 2024 09:00:00 +0000

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California Forges Ahead With Social Media Rules Despite Legal Barriers



Mark Kreidler
Tue, 23 Jul 2024 09:00:00 +0000

California lawmakers are pursuing legislation aimed at protecting children from the dangers of social media, one of many efforts around the country to confront what U.S. Surgeon General Vivek Murthy and other public experts say is a mental health emergency among young people.

But California's efforts, like those in other states, will likely face the same legal challenges that have thwarted previous legislative attempts to regulate social media. The tech industry has argued successfully that imposing rules regulating how social media operate and how people can use the online services violates the free speech rights of the companies and their customers.

A previous effort at confronting the issue, the California Age-Appropriate Design Code Act in 2022, now rests with the U.S. Court of Appeals for the 9th Circuit. A tech trade association sued to block the law and won an injunction from a lower court, largely on First Amendment grounds. The appeals court heard oral arguments in the case on July 17.

“At the end of the day, unconstitutional law protects zero children,” said Carl Szabo, vice president and general counsel for NetChoice, which argued for the tech giants before the federal appellate court.


Like the design code act, the two proposals now working their way through the California Legislature would reshape the way social media users under 18 interact with the services.

The first bill, by state Sen. Nancy Skinner (D-Berkeley), prohibits sending push notifications to children at night and during school hours. Skinner's measure also requires parental permission before platforms can send social media offerings via algorithms, which are designed to offer feeds that children didn't ask for but might keep them looking at their phones longer, rather than the traditional chronological feeds of those they follow on the app.

The second measure, by Assemblymember Buffy Wicks (D-Oakland), would amend California's privacy laws to prohibit businesses from collecting, using, selling, or sharing data on minors without their informed consent — or, for those under 13, without their parents' approval.

Both bills have bipartisan support and are backed by state Attorney General Rob Bonta. “We need to act now to protect our children,” Bonta said earlier this year, by “strengthening data privacy protections for minors and safeguarding youth against social media addiction.”

California Gov. Gavin Newsom, a Democrat, has been vocal about youth and social media, too, and recently called for a statewide ban on cellphones in schools. His positions on the two social media proposals are not yet known. “But I think the governor, like most every other Californian, is concerned about the harms of social media on kids,” Skinner said.


California's efforts are especially significant because its influence as the most populous state often results in its setting standards that are then adopted by other states. Also, some of the big tech companies that would be most affected by the laws, including Meta, Apple, Snap, and Alphabet, the parent company of Google, are headquartered in the state.

“Parents are demanding this. That's why you see Democrats and Republicans working together,” said Wicks, who with a Republican colleague co-authored the design code act that is tied up in litigation. “Regulation is coming, and we won't stop until we can keep our kids safe online.”

The fate of the design code act stands as a cautionary tale. Passed without a dissenting vote, the law would set strict limits on data collection from minors and order privacy settings for children to default to their highest levels.

NetChoice, which immediately sued to block the law, has prevailed in similar cases in Ohio, Arkansas, and Mississippi. It is challenging legislation in Utah that was rewritten after NetChoice sued over the original version. And NetChoice's lawyers argued before the U.S. Supreme Court that efforts in Texas and Florida to regulate social media content were unconstitutional. Those cases were remanded to lower courts for further review.

Though the particulars differ in each state, the bottom line is the same: Each of the laws has been stifled by an injunction, and none has taken effect.


“When you look at these sweeping laws like the California laws, they're ambitious and I applaud them,” said Nancy Costello, a clinical law professor at Michigan State University and the director of the school's First Amendment Clinic. “But the bigger and broader the law is, the greater chance that there will be a First Amendment violation found by the courts.”

The harmful effects of social media on children are well established. An advisory from Surgeon General Murthy last year warned of a “profound risk of harm” to young people, noting that a study of adolescents from ages 12 to 15 found that those who spent more than three hours a day on social media were at twice the risk of depression and anxiety as nonusers. A Gallup survey in 2023 found that U.S. teenagers spent nearly five hours a day on social media.

In June, Murthy called for warnings on social media platforms like those on tobacco products. Later that month came Newsom's call to severely restrict the use of smartphones during the school day in California. Legislation to codify Newsom's proposal is working its way through the state Assembly.

Federal legislation has been slow to materialize. A bipartisan bill to limit algorithm-derived feeds and keep children under 13 off social media was introduced in May, but Congress has done little to meaningfully rein in tech platforms — despite Meta's chief executive, Mark Zuckerberg, apologizing in a U.S. Senate hearing for “the types of things that your families have had to suffer” because of social media harms.

It remains unclear what kinds of regulation the courts will permit. NetChoice has argued that many proposed social media regulations amount to the government dictating how privately owned firms set their editorial rules, in violation of the First Amendment. The industry also leans on Section 230 of the 1996 Communications Decency Act, which shields tech companies from liability for harmful content produced by a third party.


“We're hoping lawmakers will realize that as much as you may want to, you can't end-around the Constitution,” said Szabo, the NetChoice attorney. “The government is not a substitute for parents.”

Skinner tried and failed last year to pass legislation holding tech companies accountable for targeting children with harmful content. This year's measure, which was overwhelmingly passed by the California Senate and is pending in the state Assembly, would bar tech companies from sending social media notifications to children between midnight and 6 a.m. every day, and 8 a.m. to 3 p.m. on school days. The bill also calls for platforms to require minors to obtain parental consent to use their core offerings, and would limit their use to an hour to 90 minutes a day by default.

“If the private sector is not willing to modify their product in a way that makes it safe for Californians, then we have to require them to,” Skinner said, adding that parts of her proposal are standard practice in the European Union.

“Social media has already accommodated users in many parts of the world, but not the U.S.,” she said. “They can do it. They've chosen not to.”

Wicks, meanwhile, said she considers her data bill to be about consumer protection, not speech. The proposal would close a loophole in the California Electronic Communications Privacy Act to prevent social media platforms from collecting and sharing information on anyone under 18 unless they opt in. The Assembly approved Wicks' measure without dissent, sending it to the state Senate for consideration.


Costello suggested that focusing the proposals more narrowly might give them a better chance of surviving court challenges. She is part of an effort coordinated by Harvard's T.H. Chan School of Public Health to write model legislation that would require third-party assessments of the risks posed by the algorithms used by social media apps.

“It means that we're not restricting content, we're measuring harms,” Costello said. Once the harms are documented, the results would be publicly available and could lead state attorneys general to take legal action. Government agencies adopted a similar approach against tobacco companies in the 1990s, suing for deceptive advertising or business practices.

Szabo said NetChoice has worked with states to enact what he called “constitutional and commonsense laws,” citing measures in Virginia and Florida that would mandate digital education in school. “There is a role for government,” Szabo said. (The Florida measure failed.)

But with little momentum on actual regulation at the national level, state legislators continue to try to fill the vacuum. New York recently passed legislation similar to Skinner's, which the state senator said was an encouraging sign.

Will NetChoice race for an injunction in New York? “We are having lots of conversations about it,” Szabo said.


This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

By: Mark Kreidler
Title: California Forges Ahead With Social Media Rules Despite Legal Barriers
Sourced From: kffhealthnews.org//article/california-social-media-regulations-legal-challenges-tech/
Published Date: Tue, 23 Jul 2024 09:00:00 +0000

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Rescue From Above: How Drones May Narrow Emergency Response Times



Michelle Andrews
Mon, 22 Jul 2024 09:00:00 +0000

The drones are coming.

Starting in September, if someone in Clemmons, North Carolina, calls 911 to report a cardiac arrest, the first responder on the scene may be a drone carrying an automated external defibrillator, or AED.

“The idea is for the drone to get there several minutes before first responders,” such as an emergency medical technician or an ambulance, said Daniel Crews, a spokesperson for the sheriff's office in Forsyth County, where Clemmons is located. The sheriff's office is partnering on the project with local emergency services, the Clinical Research Institute at Duke University, and the drone consulting firm Hovecon. “The ultimate goal is to save lives and improve life expectancy for someone experiencing a cardiac episode,” Crews said.

The Forsyth County program is one of a growing number of efforts by public safety and care organizations across the country to use drones to speed up lifesaving treatment in situations in which every second counts.


More than 356,000 people have a cardiac arrest outside of a hospital setting every year in the United States, according to the American Heart Association. Most people are at home when it happens, and about 90% die because they don't get immediate help from first responders or bystanders. Every minute that passes without medical intervention decreases the odds of survival by 10%.

“We've never been able to move the needle for cardiac arrest in private settings, and this technology could meet that need,” said Monique Anderson Starks, a cardiologist and associate professor of medicine at Duke University. Starks is leading pilot studies in Forsyth County and James City County, Virginia, to test whether drone AED delivery can improve treatment response times. The work is funded by a four-year grant from the American Heart Association.

A 2017 study found it takes an emergency medical services unit seven minutes, on average, to arrive on the scene following a 911 call, though response times vary considerably by region, and rural wait times can be much longer. Starks said she believes the drone-delivered AEDs in the pilot study could reduce the time to treatment by four minutes compared with first responders.

Unlike a heart attack, which occurs when blood flow to the heart is blocked, a cardiac arrest happens when a heart malfunction causes it to stop beating, typically because of an arrhythmia or an electrical problem. Eighty percent of cardiac arrests start as heart attacks. The only way to get the heart restarted is with CPR and a defibrillator.

In Forsyth County, a drone pilot from the sheriff's department will listen in on 911 calls. If there's a suspected cardiac arrest, the pilot can dispatch the drone even before emergency medical services are contacted. The drone, which weighs 22 pounds and can travel 60 mph, will fly to the location and hover 125 feet in the air before lowering an AED to the ground on a winch. The AED provides simple verbal instructions; the 911 dispatcher on the phone can also help a bystander use the AED.


Eventually there will be six drone bases in Forsyth and James City counties, Starks said.

While the technology is promising and research has often found that drones arrive faster than first responders, there's little conclusive evidence that drones improve health outcomes.

A Swedish study published in The Lancet in 2023 compared the response times between drones and ambulances for suspected cardiac arrest in 58 deployments in an area of about 200,000 people. It found that drones beat the ambulance to the scene two-thirds of the time, by a median of three minutes and 14 seconds.

In the United States, most programs are just getting started, and they are exploring the use of drones to also provide remedies for drug overdoses and major trauma or potential drowning rescues.

In Florida, Tampa General Hospital, Manatee County, and Archer First Response Systems, or AFRS, began a program in May to deliver AEDs, a tourniquet, and Narcan, a nasal spray that can reverse an opioid overdose. The program initially covers a 7-square-mile area, and EMS dispatchers deploy the drones, which are monitored by drone pilots.


There were nearly 108,000 drug overdose deaths in the United States in 2022, according to the National Institute on Drug Abuse.

As of early July, the Tampa program hadn't yet deployed any drones, said Gordon Folkes, the founder and chief executive of AFRS, which develops and deploys emergency drone logistics systems. One request in June to send a drone to an overdose couldn't be fulfilled because of a violent thunderstorm, Folkes said. In the testing area, which covers about 7,000 residents, Folkes estimates that 10 to 15 drones might be deployed each year.

“The bread and butter for these systems is suburban areas” like Manatee County that are well-populated and where the drones have the advantage of being able to avoid traffic congestion, Folkes said.

There are other uses for drones in medical emergencies. The New York Police Department plans to drop emergency flotation devices to struggling swimmers at local beaches. In Chula Vista, California, a police drone was able to pinpoint the location of a burning car, and then officers pulled the driver out, said Sgt. Tony Molina.

Rescue personnel have used drones to locate people who wander away from nursing homes, said James Augustine, a spokesperson for the American College of Emergency Physicians who is the medical director for the International Association of Fire Chiefs.


In the United States, one hurdle for drone programs is that the Federal Aviation Administration typically requires that drones be operated within the operators' visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA four months to issue a notice of proposed rulemaking on drone operations beyond the visual line of sight.

“The FAA is focused on developing standard rules to make [Beyond Visual Line of Sight] operations routine, scalable, and economically viable,” said Rick Breitenfeldt, an FAA spokesperson.

Some civil liberties groups are concerned that the FAA's new rules may not provide enough protection from drone cameras for people on the ground.

Jay Stanley, a senior policy analyst at the American Civil Liberties Union, acknowledged the benefits of using drones in emergency situations but said there are issues that need to be addressed.

“The concern is that the FAA is going to significantly loosen the reins of drones without any significant privacy protections,” he said.


KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.


This story can be republished for free (details).

By: Michelle Andrews
Title: Rescue From Above: How Drones May Narrow Emergency Response Times
Sourced From: kffhealthnews.org//article/drone-emergency-medical-response-times/
Published Date: Mon, 22 Jul 2024 09:00:00 +0000

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