NOTE: On Friday, hours after KFF Health News reported that the National Education Association had threatened to cut off striking workers’ health benefits, the union reversed course and said it would continue providing coverage. This story has been updated to reflect that decision.

The National Education Association, the nation’s largest union, reversed course Friday on its threat to cut off health insurance to about 300 Washington, D.C.-based workers in an effort to end a bitter contract dispute.

“The NEA is not discontinuing its unionized staff’s health insurance and will continue to pay insurance premiums as we bargain a new contract,” Kim Anderson, NEA’s executive director, said in a statement to KFF Health News. “Both parties have mutually agreed to mediation and we are making every effort to reach an agreement as quickly as possible.”

The NEA’s decision came just hours after KFF Health News reported on the union’s warning that it would cancel health benefits on Aug. 1 for striking workers, including some with ongoing medical issues. Reached Friday, officials at the NEA staff union could not immediately confirm whether they had been notified by the NEA.

Some private employers have used the threat of cutting off health benefits as leverage against unionized workers, a tactic that has drawn scrutiny from congressional Democrats and is prohibited for state employers in California. Experts on labor law say they’ve never seen a union make the move against its own workers.

“This is like a man-bites-dog situation where the union is now in a position as the employer,” said Paul Clark, a professor of labor and employment relations at Penn State University. “It’s not a good look for a union.”

NEA workers with pressing health needs were worried but said they wouldn’t fold. Joye Mercer Barksdale, a writer on the NEA’s government relations team, said she needs coverage for a medical procedure to address atrial fibrillation, a cardiac disorder. “This is insane for the NEA to use our health benefits as a bargaining chip,” she said.

But Barksdale had said she was “not ready to give in.” Reached Friday morning, she said she was thrilled by the reversal: “Oh my God, I am so thankful.”

The NEA Staff Organization, the union representing workers at the NEA’s headquarters, launched a strike on July 5 in Philadelphia, during the union’s annual delegate assembly. It was its second walkout this summer as the two parties negotiate a new contract, navigating sticking points such as wages and remote work.

In response, the NEA ended the conference early. President Joe Biden was supposed to speak at the event but withdrew, refusing to cross the picket line. The NEA on July 24 endorsed Kamala Harris for president.

On July 8, the day after the conference had been scheduled to end, the NEA locked out workers. In a letter the day before, the NEA informed its unionized workers that they would not be paid, effective immediately, and their health benefits would expire at the end of July unless a new deal were reached.

“NEA cannot allow NEASO to act again in a way that will bring such lasting harm to our members and our organization,” Anderson, the NEA’s executive director, wrote in the letter, obtained by KFF Health News. “We are, and have always been, committed both to our union values and to the importance of conducting ourselves as a model employer.”

Democrats in Congress, including Sens. Sherrod Brown of Ohio and Bob Casey of Pennsylvania, introduced legislation last year to protect striking workers from losing their health benefits, after several large companies, including General Motors, John Deere, RTX (formerly Raytheon Technologies), and the maker of Kellogg’s cereals, threatened to or did cut off coverage during labor disputes.

“Workers shouldn’t have to choose between their family’s health and a fair contract,” Brown said in a statement to KFF Health News.

The legislation was endorsed by large labor unions including the Service Employees International Union and United Steelworkers, according to a press release from Brown’s office. The NEA wasn’t among them.

“This tactic is immoral, and it should be illegal,” United Steelworkers’ president at the time, Thomas Conway, said in the release.

Officials at the NEA, which represents teachers and other administrators, declined an interview request. In a statement Wednesday, the organization’s president, Becky Pringle, said “we are making every effort to reach an agreement as quickly as possible” with its staff union.

“As union leaders who have been on strike, we recognize the significance and impact of these important decisions on a personal and family level. We truly value our employees and look forward to continued collaboration with NEASO to develop a new contract that benefits us all,” she said.

Kate Hilts, a digital strategist who works for the NEA, said she feared losing her coverage would leave her unable to afford treatment for a rare autoimmune disease that attacks her kidneys. Her next treatment was slated for August.

“I wake up every day and can’t believe this is happening,” she said. “You would expect this from an employer that is antiworker or has a terrible labor record, but I am totally flabbergasted that a labor union would do this that bills itself as pro-worker, pro-family, pro-education, and pro-children.”

The NEA staff union has filed multiple charges with the National Labor Relations Board this year, including allegations that the NEA withheld holiday overtime pay and failed to provide information on the outsourcing of millions of dollars in bargaining unit work.

California is one of the only states that protect striking workers from losing health coverage. The state legislature passed a law in 2021 that blocks the tactic from being used against public employees and another law in 2022 that allows any striking workers who lose their insurance to immediately get heavily discounted coverage through the state’s Affordable Care Act marketplace.

If they had remained locked out, the NEA workers would have been eligible for coverage under COBRA, a federal program that allows people who are fired or laid off to maintain their employer-sponsored insurance for 18 months.

But the coverage can be a financial hardship, as individuals often must pay the entire cost of their insurance premiums, plus a 2% administrative fee.

Another option for workers would have been coverage through the Affordable Care Act marketplace, though that also can be costly. And it may have been unclear how soon that coverage would begin or whether insurers would cover their existing doctors.

“I’m hoping the NEA will be so ashamed of what they are doing that, at the very least, they will not take away our health benefits,” Barksdale said before the NEA’s decision.

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The Host Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

As Vice President Kamala Harris appears poised to become the Democratic Party’s presidential nominee, health policy in general and reproductive health issues in particular are likely to have a higher profile. Harris has long been the Biden administration’s point person on abortion rights and reproductive health and was active on other health issues while serving as California’s attorney general.

Meanwhile, Congress is back for a brief session between presidential conventions, but efforts in the GOP-led House to pass the annual spending bills, due by Oct. 1, have run into the usual roadblocks over abortion-related issues.

This week’s panelists are Julie Rovner of KFF Health News, Stephanie Armour of KFF Health News, Rachel Cohrs Zhang of Stat, and Alice Miranda Ollstein of Politico.

Panelists Stephanie Armour KFF Health News @StephArmour1 Read Stephanie's stories. Rachel Cohrs Zhang Stat News @rachelcohrs Read Rachel's stories. Alice Miranda Ollstein Politico @AliceOllstein Read Alice's stories.

Among the takeaways from this week’s episode:

• President Joe Biden’s decision to drop out of the presidential race has turned attention to his likely successor on the Democratic ticket, Vice President Kamala Harris. At this late hour in the campaign, she is expected to adopt Biden’s health policies, though many anticipate she’ll take a firmer stance on restoring Roe v. Wade. And while abortion rights supporters are enthusiastic about Harris’ candidacy, opponents are eager to frame her views as extreme.
• As he transitions from incumbent candidate to outgoing president, Biden is working to frame his legacy, including on health policy. The president has expressed pride that his signature domestic achievement, the Inflation Reduction Act, took on the pharmaceutical industry, including by forcing the makers of the most expensive drugs into negotiations with Medicare. Yet, as with the Affordable Care Act’s delayed implementation and results, most Americans have yet to see the IRA’s potential effect on drug prices.
• Lawmakers continue to be hung up on federal government spending, leaving appropriations work undone as they prepare to leave for summer recess. Fights over abortion are, once again, gumming up the works.
• In abortion news, Iowa’s six-week limit is scheduled to take effect next week, causing rippling problems of abortion access throughout the region. In Louisiana, which added the two drugs used in medication abortions to its list of controlled substances, doctors are having difficulty using the pills for other indications. And doctors who oppose abortion are pushing higher-risk procedures, like cesarean sections, in lieu of pregnancy termination when the mother’s life is in danger — as states with strict bans, like Texas and Louisiana, are reporting a rise in the use of surgeries, including hysterectomies, to end pregnancies.
• The Government Accountability Office reports that many states incorrectly removed hundreds of thousands of eligible people from the Medicaid rolls during the “unwinding” of the covid-19 public health emergency’s coverage protections. The Biden administration has been reluctant to call out those states publicly in an attempt to keep the process as apolitical as possible.

Also this week, Rovner interviews Anthony Wright, the new executive director of the consumer health advocacy group Families USA. Wright spent the past two decades in California, working with, among others, now-Vice President Kamala Harris on various health issues.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too: 

Julie Rovner: NPR’s “A Study Finds That Dogs Can Smell Your Stress — And Make Decisions Accordingly,” by Rachel Treisman.  

Alice Miranda Ollstein: Stat’s “A Pricey Gilead HIV Drug Could Be Made for Dramatically Less Than the Company Charges,” by Ed Silverman, and Politico’s “Federal HIV Program Set To Wind Down,” by Alice Miranda Ollstein and David Lim. 

Stephanie Armour: Vox’s “Free Medical School Won’t Solve the Doctor Shortage,” by Dylan Scott.  

Rachel Cohrs Zhang: Stat’s “How UnitedHealth Harnesses Its Physician Empire To Squeeze Profits out of Patients,” by Bob Herman, Tara Bannow, Casey Ross, and Lizzy Lawrence. 

Also mentioned on this week’s podcast:

• States Newsroom’s “Anti-Abortion Researchers Back Riskier Procedures When Pregnancy Termination Is Needed, Experts Say,” by Sofia Resnick.
• KFF Health News’ “Louisiana Reclassifies Drugs Used in Abortions as Controlled Dangerous Substances,” by Rosemary Westwood, WWNO.
• The New York Times’ “Biden and Georgia Are Waging a Fight Over Medicaid and the Future of Obamacare,” by Noah Weiland.

Credits Francis Ying Audio producer Emmarie Huetteman Editor

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Not so long ago, Bonner General Health, the hospital in Sandpoint, Idaho, had four OB/GYNs on staff, who treated patients from multiple rural counties.

That was before Idaho’s near-total abortion ban went into effect almost two years ago, criminalizing most abortions. All four of Bonner’s OB/GYNs left by last summer, some citing fears that the state’s ban exposed them to legal peril for doing their jobs.

The exodus forced Bonner General to shutter its labor and delivery unit and sent patients scrambling to seek new providers more than 40 miles away in Coeur d’Alene or Post Falls, or across the state border to Spokane, Wash. It has made Sandpoint a “double desert,” meaning it lacks access to both maternity care and abortion services.

One patient, Jonell Anderson, was referred to an OB-GYN in Coeur d’Alene, roughly an hour’s drive from Sandpoint, after an ultrasound showed a mass growing in her uterus. Anderson made multiple trips to the out-of-town provider. Previously, she would have found that care close to home.

The experience isn’t limited to this small Idaho town.

A 2023 analysis by ABC News and Boston Children’s Hospital found that more than 1.7 million women of reproductive age in the United States live in a “double desert.” About 3.7 million women live in counties with no access to abortion and little to no maternity care.

Texas, Mississippi and Kentucky have the highest numbers of women of reproductive age living in double deserts, according to the analysis.

Amelia Huntsberger, one of the OB/GYNs who chose to leave Sandpoint — despite having practiced there for a decade — did so because she felt she couldn’t provide the care her patients needed under a law as strict as Idaho’s.

The growing provider shortages in rural states affect not only pregnant and postpartum women, but all women, said Usha Ranji, an associate director for Women’s Health Policy at KFF, a health information nonprofit that includes KFF Health News.

“Pregnancy is obviously a very intense period of focus, but people need access to this care before, during and after, and outside of pregnancy,” Ranji said.

The problem is expected to worsen.

In Idaho, the number of applicants to fill spots left by departing doctors has “absolutely plummeted,” said Susie Keller, CEO of the Idaho Medical Association.

“We are witnessing the dismantling of our health system,” she said.

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Sacramento, California. — Los californianos que trabajan en espacios interiores están recibiendo protecciones inmediatas contra el calor extremo, cuando el estado enfrenta temperaturas de tres dígitos.

California ha tenido estándares para proteger a los trabajadores al aire libre del calor desde 2005, pero el estado anunció el miércoles 24 de julio que ya había acelerado la revisión de un conjunto de reglas para los trabajadores en interiores.

La Junta de Normas de Seguridad y Salud Ocupacional del estado aprobó la regulación en junio, pero necesitaba ser evaluada para su cumplimiento legal.

“Esta regulación proporciona protecciones para los trabajadores en todo California y ayuda a preparar a los empleadores para enfrentar los desafíos de las temperaturas en aumento en ambientes interiores”, dijo Debra Lee, jefa de la División de Seguridad y Salud Ocupacional estatal.

California es uno de los pocos estados que están actuando frente a los crecientes impactos del cambio climático y el calor extremo con estándares de seguridad para los trabajadores.

A principios de este mes, la administración Biden propuso reglas federales para proteger a los trabajadores en interiores y exteriores, ya que el calor extremo, el asesino número 1 relacionado con el clima número en el país, se vuelve aún más peligroso.

Los estándares de California requieren que los lugares de trabajo en interiores se mantengan por debajo de los 87 grados Fahrenheit cuando hay empleados presentes, y por debajo de 82 grados en lugares donde los trabajadores usan ropa protectora o están expuestos al calor radiante, como hornos.

Los sitios de trabajo que no tienen aire acondicionado pueden usar ventiladores, nebulizadores y otros métodos para bajar la temperatura.

Las reglas permiten alternativas para los negocios si no pueden enfriar sus espacios lo suficiente. En esos casos, los empleadores deben proporcionar a los trabajadores agua, descansos, áreas donde puedan refrescarse, chalecos refrigerantes u otros medios para evitar el sobrecalentamiento.

Pero incluso con alternativas, las empresas están preocupadas por el costo de cumplir con la regulación, especialmente las pequeñas empresas que no son dueñas de sus locales o están en edificios antiguos, dijo Robert Moutrie, defensor de políticas senior en la Cámara de Comercio de California.

“La respuesta más simple a esta regulación es el aire acondicionado, y eso es una inversión costosa”, dijo Moutrie. “Si eres una pequeña empresa y no eres dueño de tu estructura, no puedes hacer cambios como crear un nuevo espacio para refrescarte”.

Las reglas se han estado desarrollando desde 2016, retrasadas, en parte, por la pandemia de covid. La Junta de Seguridad Laboral pidió que las regulaciones se aceleraran. Una revisión estándar habría retrasado la entrada en vigencia de la regulación hasta el otoño, dejando a los trabajadores en gran medida desprotegidos del calor del verano.

La regulación se aplica a la mayoría de los lugares de trabajo en interiores, incluidas aulas e incluso vehículos de reparto. Pero los reguladores estatales dejaron fuera a las prisiones y las instalaciones correccionales locales después que la administración del gobernador Gavin Newsom proyectara que podría costar miles de millones de dólares al Departamento de Correcciones y Rehabilitación de California implementarlas.

La junta tiene la intención de redactar una regulación separada para los miles de trabajadores en las 33 prisiones estatales, campamentos de conservación y cárceles locales del estado. Eso podría llevar un año, si no más.

En 2021, el Departamento de Salud y Servicios Humanos (HHS) informó que ocurrieron 1,602 muertes relacionadas con el calor a nivel nacional, lo que probablemente sea un subregistro porque los proveedores de atención médica no están obligados a informarlas.

En 2023, el HHS informó 2,302 muertes relacionadas con el calor. No está claro cuántas de estas muertes estuvieron vinculadas al trabajo, ya sea en interiores o exteriores.

Mientras tanto, en junio, las temperaturas globales registraron récords históricos por decimotercer mes consecutivo.

“Este es realmente uno de los mayores problemas de seguridad que vemos que los trabajadores experimentan en California en muchas industrias”, dijo Tim Shadix, director legal del Warehouse Worker Resource Center, que abogó por las protecciones. “Y el problema solo está empeorando con el cambio climático y los veranos más calurosos”.

Esta historia fue producida por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

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Montana’s proposal to increase oversight is part of a national trend by states to ensure nonprofit hospitals act as charitable organizations as they claim tax-exempt status. LISTEN here:

https://kffhealthnews.org/wp-content/uploads/sites/2/2024/07/Community-Benefits-for-KFF.mp3

The proposal comes some four years after a state audit found shortcomings in the health department’s oversight. The rules largely mirror federal requirements that national health policy analysts said have yet to lead to any meaningful enforcement.

“What is being proposed in Montana doesn’t really move the needle,” said Kevin Barnett, a researcher with the California-based nonprofit Public Health Institute who has studied hospital community benefits for decades. “It kicks the can down the road to say ‘we’ll consider this another day.’”

State officials would now be paying more attention, he said, but the impact depends on what they do with the information.

Montana’s plan is part of a national trend by states to try to cover federal enforcement gaps. The state would join at least 10 others that require nonprofit hospitals to create a broad community benefit plan and 25 states that mandate the facilities publicly share their financial assistance policies, according to The Hilltop Institute, a think tank at the University of Maryland-Baltimore County.

Policymakers have focused on nonprofit hospitals as a growing number of people in the U.S. struggle to afford medical care and, altogether, owe at least $220 billion in medical debt. The debt disproportionately affects people in poverty and Black people, according to data analyzed by KFF, a health information nonprofit that includes KFF Health News.

States with set giving standards take different approaches. In recent years, California adopted new reporting requirements for hospitals to show how they serve vulnerable populations. Oregon created new rules for when and how hospitals must provide patients discounted care. And five states — Illinois, Nevada, Pennsylvania, Texas, and Utah — have set minimums that hospitals must spend toward community benefits.

Just over half of the hospitals in the U.S. are nonprofits. While each must report the “community benefits” they provide, federal law doesn’t specify which services qualify or how much to give. Inconsistent hospital reports make it difficult to distinguish between low and high givers.

Montana’s 2020 state audit found that hospitals report benefits vaguely and inconsistently. The following year, a KFF Health News investigation found that, even by hospitals’ own reports, some of Montana’s richest facilities fell behind the national average in community benefit spending.

A Montana law passed in 2023 requires the state health department to track hospitals’ giving and to define standards. The department’s proposed rules spell out some requirements, such as calling on hospitals to post financial assistance policies prominently online. But mostly, the list of requirements sets the stage for more to come.

Holly Matkin, a health department spokesperson, said the agency will establish standards that are “fair to all nonprofit hospitals.” The state plans to collect data over a three-year period to begin establishing standards in 2026.

The state’s proposed rules have some differences from federal requirements, such as mandating hospital-level reports as opposed to systemwide information that covers numerous hospital locations. They also leave room for the state to seek more details about how hospitals provide care at reduced prices, such as the number of people who receive financial aid or the average amount given per person.

But the Montana Hospital Association lobbied legislators against including too many reporting rules, arguing it would increase hospitals’ administrative burden. State lawmakers then narrowed the data the state can collect to largely the information hospitals already provide to the federal government. The association supports the state’s rules as proposed but has said any state standards need flexibility.

“The truth is that most communities have more health needs than they can effectively address,” said Bob Olsen, president and CEO of the Montana Hospital Association. “Models that apply a one-size-fits-all standard on communities take decision-making out of local communities, and have the potential to do more harm than good.”

Adam Zarrin, director of state government affairs with the Leukemia & Lymphoma Society, supported Montana’s proposal during a June 18 public hearing. But he testified that Montana could do more, such as mandating screening for financial assistance and requiring that hospitals provide it to patients at particular income levels.

“These rules could go even further to provide greater access and protections for Montanans who need and apply for financial assistance,” Zarrin said.

Health department officials said they plan to create numerical or narrative standards for judging how hospitals say they’ve responded to people’s needs — or a combination of the two. Officials are still vague on what either standard could entail. But they have said the benchmarks would be set each year based on each hospital’s size and patient revenue. Hospitals with operating losses wouldn’t have to meet the forthcoming rules.

Ge Bai, a health policy professor at Johns Hopkins University who has long studied hospitals’ community benefits, said such standards come with trade-offs. For example, standards that can be met through words rather than numbers might allow large hospitals to pay consultants to window-dress the story of their benefits while smaller systems struggle to show their worth. She said numerical rules, such as spending minimums, could cause some hospitals to slow efforts once they meet the state’s requirement.

“It’s not perfect,” Bai said. “But If we don’t do anything, well, that’s the status quo.”

In 2020, Oregon set minimums for the free or discounted care hospitals must provide, but even with those rules, the state’s overall charity care spending didn’t increase, Bai said. Last summer, lawmakers there added a new set of rules, including that hospitals must screen patients with large hospital bills to see if they qualify for financial assistance.

California also has implemented a combination of standards. In recent years, the state expanded reporting requirements, mandating that nonprofit hospitals explain the math behind their community benefits tally and detail how they’re serving vulnerable populations such as people who are homeless. The state also mandated that hospitals offer discounted care to uninsured patients or some people with costly medical bills.

Even in states like California, it can be hard to see how those policies affect patients who struggle to access care, said Barnett of the Public Health Institute. He said he’d like to see states require hospitals to reduce health disparities with specific outcomes, such as lowering preventable emergency room visits by people from especially poor neighborhoods.

In 2025, California will start requiring hospitals to submit annual reports that include an analysis of access to care and a plan to address disparities. The state is still defining those reporting rules.

Whatever standard states employ, health policy researchers said promoting transparency is key, such as by standardizing reporting rules to provide a clear picture across systems. Bai said Montana’s rules are a good first step.

Matkin, from the state health department, said whatever giving benchmarks Montana sets won’t be a copy-and-paste of what others have tried. The department plans to create standards unique to Montana.

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SACRAMENTO, Calif. — Californians working indoors are getting immediate protections from extreme heat as much of the state bakes in triple-digit temperatures this week.

California has had heat standards on the books for outdoor workers since 2005, but the state announced Wednesday that a set of rules for indoor workers had been finalized following an expedited review. The state’s Occupational Safety and Health Standards Board approved the regulation last month, but it needed to be vetted for legal compliance.

“This regulation provides protections for workers across California and helps prepare employers to deal with the challenges of rising temperatures in indoor environments,” said Debra Lee, chief of California’s Division of Occupational Safety and Health.

California is among a few states responding to the growing impacts of climate change and extreme heat with worker safety standards. Earlier this month, the Biden administration proposed federal rules to protect indoor and outdoor workers from heat exposure as extreme heat, already the No. 1 weather-related killer in the U.S., becomes even more dangerous.

California’s standards require indoor workplaces to be cooled below 87 degrees Fahrenheit when employees are present and below 82 degrees in places where workers wear protective clothing or are exposed to radiant heat, such as furnaces. Worksites that don’t have air conditioning may use fans, misters, and other methods to bring the room temperature down.

The rules allow workarounds for businesses if they can’t cool their workplaces sufficiently. In those cases, employers must provide workers with water, breaks, areas where they can cool down, cooling vests, or other means to keep them from overheating.

But even with workarounds, businesses are concerned about the cost of complying with the regulation, especially small businesses that don’t own their storefronts or are in old buildings, said Robert Moutrie, a senior policy advocate at the California Chamber of Commerce.

“The simplest answer to this regulation is AC, and that’s a costly investment,” Moutrie said. “If you’re a small business and you don’t own your structure, you can’t make changes like creating a new space to cool down.”

The rules have been in development since 2016 — delayed, in part, because of the covid pandemic. The worker safety board requested the regulations be expedited. A standard review would have delayed the regulation taking effect until the fall, leaving workers largely unprotected from the summer heat.

The regulation applies to most indoor workplaces, including classrooms and even delivery vehicles. But state regulators exempted prisons and local correctional facilities after Gov. Gavin Newsom’s administration projected it could cost the California Department of Corrections and Rehabilitation billions of dollars to implement.

The board intends to draft a separate regulation for the tens of thousands of workers at the state’s 33 state prisons, conservation camps, and local jails. That could take a year, if not longer.

In 2021, the Department of Health and Human Services reported, 1,602 heat-related deaths occurred nationally, which is likely an undercount because health care providers are not required to report them. In 2023, HHS reported, 2,302 heat-related deaths occurred. It’s not clear how many of these deaths are related to work, either indoors or outdoors.

Meanwhile, global temperatures in June were a record high for the 13th straight month.

“This is really one of the biggest safety issues we see workers experiencing across California in many different industries,” said Tim Shadix, legal director at the Warehouse Worker Resource Center, which lobbied for the protections. “And the problem is only getting worse with climate change and hotter summers.”

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

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A report detailing findings from the Tribal CX Pilot for Post-Award Reporting project.

Health insurance agents who fraudulently enroll consumers in Affordable Care Act health plans could be subject to criminal charges — and civil penalties of $10,000 to $200,000 — under legislation introduced Wednesday by Sen. Ron Wyden (D-Ore.), chairman of the powerful Senate Finance Committee.

Wyden first promised the bill in May, when he called on federal regulators to do more to combat sketchy Obamacare enrollment schemes. Often, consumers who are targeted don’t know they’ve been enrolled or that their coverage has been switched to a new plan until they lose access to preferred doctors, learn they have different deductibles, or find they owe taxes for ACA insurance premium subsidies.

The schemes exploit the federal health insurance enrollment system, which requires only minimal proof of identity — a name, birth date, and state — for a broker to create or access an account. The lure is monthly commissions paid by insurance companies — amounts that are only about $25 per person but can add up when multiplied across transactions.

“It is critical for these bad actors to be held criminally responsible and implement common sense consumer protections so working families can confidently purchase quality, affordable health insurance that works for them through honest brokers,” Wyden said in a statement.

The Centers for Medicare & Medicaid Services said July 19 that more than 200,000 people have complained about unauthorized Obamacare enrollment or plan switches this year.

KFF Health News began reporting on Affordable Care Act enrollment schemes this spring.

CMS’ directive last week also detailed new rules aimed at thwarting the problem by blocking agents from making changes to consumers’ coverage unless they are already “associated” with that policyholder’s account, or take other steps to verify that they have consumers’ permission.

Wyden’s proposal, co-sponsored by Democratic Sens. Sherrod Brown of Ohio, Tammy Duckworth of Illinois, Patty Murray of Washington, Brian Schatz of Hawaii, and Chris Van Hollen of Maryland, would call on federal regulators to begin verifying that consumers have granted consent to brokers for ACA enrollment or plan switches, and to notify consumers whenever a change is made to their accounts or coverage.

The civil penalties would range from at least $10,000, in cases of straightforward negligence, to as much as $200,000 for agents who “knowingly and willfully” submit fraudulent information.

Wyden’s bill faces a seemingly impossible climb, landing in a very polarized Senate during an election year.

But next year, the ACA will be in the spotlight as Congress must decide whether to extend beyond 2025 enhanced subsidies that help people purchase coverage. Increased subsidies were instituted under the Biden administration at the height of the pandemic and are considered a key factor behind recent record ACA enrollment.

Some Republican lawmakers have demanded investigations of ACA enrollment-switching schemes, which they allege may be part of a larger problem of brokers or consumers misstating their incomes to garner insurance subsidies. Obamacare supporters say the complaint is a partisan effort to stop the enhanced subsidies from becoming permanent.

Sen. Chuck Grassley (R-Iowa) sent a letter July 8 to CMS questioning how federal regulators verify incomes for those who get subsidies and what enforcement efforts are underway related to potential ACA subsidy fraud.

Wyden’s office said his proposal is supported by some insurers and agent groups, including AHIP, the trade association for insurance companies; individual insurers like Centene Corp.; and several disease-specific patient advocacy groups, including the Leukemia & Lymphoma Society, the American Cancer Society Cancer Action Network, and the National Multiple Sclerosis Society.

Health Agents for America, a group that has sought solutions to the issue, supports criminal charges for agents found to be falsely enrolling or switching consumers but stopped short of endorsing Wyden’s bill. Ronnell Nolan, its president and CEO, said her organization would like to see more effort “to hold CMS responsible” for allowing what she views as security loopholes in private sector enrollment websites, and in enforcement actions against bad actors.

“The bottom line is to stop fraud and help the consumer,” she said.

In a July 19 letter to Wyden’s office, CMS Administrator Chiquita Brooks-LaSure outlined steps the agency has taken to increase “oversight of agents and brokers to protect consumers” — including suspending 200 agents in recent weeks from enrolling clients in Obamacare plans.

“The numbers being addressed are very low,” said Nolan, who suspects it isn’t just individual rogue agents seeking commissions by changing ACA enrollments, but a larger effort using automation to rapidly enroll or switch consumer policies.

Nolan and other agents say federal regulators should simply require private Obamacare enrollment sites to add layers of security before agents can access consumer accounts.

Eighteen states and the District of Columbia run their own ACA marketplaces and require additional security measures, including two-factor authentication, before consumer accounts can be accessed. Two-factor authentication, a common internet security feature, requires people to enter a code — usually sent to their phones — before accessing accounts at banks, social media platforms, and many other services.

The state-run enrollment sites report far fewer problems than the federal marketplace, Nolan and others say. If CMS simply added two-factor authentication to healthcare.gov, Nolan said, “all these other shenanigans would not happen.”

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Behavioral health expansion funding

WALL, S.D. — Stacey Schulz parks in a rear lot to avoid the crowded Main Street entrances to her local pharmacy.

“During the summer, it’s kind of hectic,” she said after greeting the pharmacist and technician by name.

That’s because Schulz’s pharmacy is tucked inside Wall Drug, a tourist attraction that takes up almost an entire block and draws more than 2 million visitors a year to a community of fewer than 700 residents.

The business is named after the town of Wall, which is just off Interstate 90 near Badlands National Park. Colorful, hand-painted billboards dot the roadside for hundreds of miles, telling motorists how far they are from Wall Drug’s free ice water, 5-cent coffee, and homemade doughnuts. Visitors can pan for gold, listen to singing animatronic cowboys, try on Western wear, and shop for souvenirs, including plush jackalopes — mythical jackrabbits with antelope horns.

Despite being part of a booming tourist attraction, Wall Drug’s pharmacy faces challenges common to independent rural pharmacies.

It’s the lone pharmacy in Wall, serving locals year-round. Some, like Schulz, live in town, while others live on ranches as far as 60 miles away. The next-nearest pharmacy is a 30-minute drive northeast.

Wall Drug also serves tourists who forget their prescriptions at home, get sick while roaming the country in their RVs, or hurt themselves while hiking through the otherworldly rock formations of the scorching Badlands, said Cindy Dinger, its sole pharmacist.

Wall has no hospital, but a clinic is open four days a week. Schulz, a medical assistant there, said she and her co-workers see a lot of summer tourists. They send them to Wall Drug to pick up prescriptions.

“And then we tell them to get fudge before they leave,” Schulz said.

Rural pharmacies, especially independent ones, closed at a higher rate from 2003 to 2021 than pharmacies in other areas, according to a study by the Rural Policy Research Institute. By 2021, the institute found, nearly 8% of rural counties were left with no pharmacy. The Wall Drug pharmacy has fewer customers than a typical city pharmacy, which can mean less profit, Dinger said.

She said some of its prices are higher because the store can’t negotiate discounts as steep as the deals suppliers grant chain pharmacies. Rural drugstores also lack leverage with insurers, and they face increasing competition from mail-order pharmacies.

Another challenge is staffing. When Dinger needs time off, she finds a fill-in from Rapid City, nearly an hour’s drive away.

“It’s a challenge getting relief if I want to go on vacation or if I need a cover so that I can go to a doctor’s appointment,” she said. “You take what you can get and try to schedule around it.”

Dinger said her pharmacy would struggle without the rest of Wall Drug.

“All this stuff around us — the poster and print shop, the boot shop, the fudge shop, the café — they pay our bills,” she said.

The pharmacy’s white facade, with stained-glass signs and windows, is modeled after that of the original drugstore, which was across the street. The window displays and top shelves inside the store are filled with vintage pharmacy supplies, including manuals, glass medicine bottles, and a suppository-making machine.

Tourists carrying shopping bags and sporting new cowboy hats stop to look at the displays. “It’s a real pharmacy,” a woman said, sounding surprised.

Dinger and Sylvia Smith, the store’s only pharmacy tech, ring customers up below a Tiffany-style light fixture and retrieve prescriptions stored behind a wooden desk and wall.

Customer Will Lovitt said a friend advised him and his wife to stop at Wall Drug during their drive from Indiana to the Black Hills in western South Dakota. Lovitt developed a rash on the trip and ended up using the visit to get Dinger’s advice on treating it.

He said it can be difficult for tourists to know where to find medical help, especially when driving through rural states like South Dakota.

“I think it’s time that America gets back to the grass roots of the small-town doctor and the small-town pharmacist,” Lovitt said.

Alex Davis and a friend decided to visit Wall Drug on their road trip from Kansas to Yellowstone National Park.

“Then, when I saw there was a little pharmacy, I thought I’d grab something that I needed,” she said.

Davis bought Dramamine to treat car sickness on the long drive.

Dinger said she occasionally sees unusual situations, like the time several years ago when a park ranger needed antibiotics after getting bitten by a prairie dog.

“You never know what kind of diseases they might be carrying,” she said of the animals, which recently were hit with an outbreak of plague.

Rick Hustead is the chairman of Wall Drug. The store was opened in 1931 by his grandfather, pharmacist Ted Hustead. Ted’s wife, Dorothy, had the idea to advertise its soda fountain and free ice water to tourists traveling along unpaved roads during the hot years of the Dust Bowl era. Rick’s father, pharmacist Bill Hustead, began expanding the store in the ’50s, turning it into the tourist magnet it is today.

Rick Hustead didn’t follow his father and grandfather’s path to pharmacy school, so he had to recruit pharmacists from elsewhere.

Hustead found Dinger in 2010 after writing a letter to each pharmacist in the state.

Dinger said she was living at the time in Sioux Falls, South Dakota’s most populous city. But she and her husband were interested in raising their kids in a small town, the way she grew up. Dinger was also attracted by the store’s limited hours: She’d be done working by 5 p.m. on weekdays and have the weekends off.

Hustead said his family has never considered closing the pharmacy, even though it’s not the main attraction for most visitors.

“We can’t be Wall Drug without being a drugstore,” he said.

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Louisiana lawmakers have added two drugs commonly used in pregnancy and reproductive health care to the state’s list of controlled dangerous substances, a move that has alarmed doctors in the state.

Mifepristone and misoprostol have many clinical uses, and one use approved by the FDA is to take the pills to induce an abortion at up to 10 weeks of gestation.

The bill that moved through the Louisiana Legislature this spring lists both medications as Schedule IV drugs under the state’s Uniform Controlled Dangerous Substances Law, creating penalties of up to 10 years in prison for anyone caught with the drugs without a valid prescription. Gov. Jeff Landry, a Republican, signed the bill into law in May. It takes effect Oct. 1.

The new law is the latest move by anti-abortion advocates trying to control access to abortion medications in states with near-total abortion bans, such as Louisiana. The law is the first of its kind, opening a new front in the state-by-state battle over reproductive medicine.

Republican-controlled states have passed various laws regulating medication abortion in the past, said Daniel Grossman, an OB-GYN and a reproductive health researcher at the University of California-San Francisco.

But after the Dobbs v. Jackson Women’s Health Organization decision in 2022, in which the Supreme Court ruled there was no constitutional right to an abortion, scrutiny of medication abortions escalated as clinics in certain states shuttered completely or were required to stop offering in-clinic procedures.

“It’s not surprising that states are trying everything they can to try to restrict these drugs,” Grossman said. “But this is certainly a novel approach.”

Before the Louisiana bill passed, more than 250 OB-GYNs and emergency, internal medicine, and other physicians from across the state signed a letter to the bill’s sponsor, state Sen. Thomas Pressly, a Republican, arguing the move could threaten women’s health by delaying lifesaving care.

“It’s just really jaw-dropping,” said Nicole Freehill, a New Orleans OB-GYN who signed the letter. “Almost a day doesn’t go by that I don’t utilize one or both of these medications.”

Mifepristone and misoprostol are routinely used to treat miscarriages, stop obstetric hemorrhaging, induce labor, or prepare the cervix for a range of procedures inside the uterus, such as inserting an IUD or taking a biopsy of the uterine lining.

Bill Born From a Family’s Misfortune

The proposal to reschedule the drugs as controlled dangerous substances was introduced as amendments to Pressly’s original bill creating the crime of “coerced criminal abortion” — where someone “knowingly” gives abortion pills to a pregnant woman to cause or attempt to cause an abortion “without her knowledge or consent.”

Pressly’s sister, Catherine Pressly Herring, testified at the hearing on the bill that she had been given abortion drugs without her knowledge by her former husband. Pressly said his sister’s story prompted the legislation.

In a statement, Pressly said that he added the new amendments to “control the rampant illegal distribution of abortion-inducing drugs.” He did not respond to requests for comment.

“By placing these drugs on the controlled substance list, we will assist law enforcement in protecting vulnerable women and unborn babies,” Pressly wrote in this statement.

Louisiana Right to Life, the state’s most influential anti-abortion group, helped draft the bill. And the group’s communications director, Sarah Zagorski, said that claims that rescheduling the drugs as dangerous could harm women’s health are “fearmongering.”

The real problem, she said, is that mifepristone and misoprostol are too accessible in Louisiana and are being used to induce abortions despite the state’s ban.

“We’ve had pregnancy centers email us with many stories of minors getting access to this medication,” Zagorski said.

Studies have shown a surge in the ordering of abortion pills online in states that have severe restrictions on abortion.

In the Louisiana Legislature committee hearing on the bill, anti-abortion advocates said that physicians would still be allowed to dispense mifepristone and misoprostol for lawful medical care, and that women who give themselves abortions using the medications would be exempted from criminal liability.

“Under this law, or any abortion law, in Louisiana we see the woman as often the second victim,” testified Dorinda Plaisance, a lawyer who works with Louisiana Right to Life. “And so Louisiana has chosen to criminalize abortion providers” rather than women who use the medications for their own abortions.

Move ‘Not Scientifically Based,’ Doctors Say

The U.S. Drug Enforcement Administration and individual states have the power to list drugs as controlled dangerous substances.

State and federal regulations aim to control access to drugs, such as opioids, based on their medical benefit and their potential for abuse, according to Joseph Fontenot, executive director of the Louisiana Board of Pharmacy, the agency that monitors drugs listed as controlled dangerous substances.

Like other states, Louisiana tracks prescriptions in databases that include the name of the patient, the health provider who wrote the prescription, and the dispensing pharmacy.

Physicians need a special license to prescribe the drugs — in 2023, there were 18,587 physicians in Louisiana, 13,790 of whom had a license to prescribe controlled dangerous substances, according to data from the Louisiana State Board of Medical Examiners and the Board of Pharmacy.

“Every state has a prescription drug monitoring program. And they really are designed to identify prescription drug mills that are hawking fentanyl and opioid painkillers,” said Robert Mikos, a professor of law and a drug policy expert at Vanderbilt University.

What happened to Pressly’s sister — being tricked into taking mifepristone or misoprostol — is a form of drug abuse, said Zagorski of Louisiana Right to Life, which is why the drugs should be more strictly controlled.

But Fontenot, of the Louisiana Board of Pharmacy, said that under Louisiana’s law, abuse refers to addiction. Jennifer Avegno, a New Orleans emergency physician and the director of the New Orleans Health Department, agrees. “There is no risk of someone getting hooked on misoprostol,” Avegno said.

Under the new law, mifepristone and misoprostol will be added to a list comprised of opioids, depressants, and stimulants. “To classify these medications as a drug of abuse and dependence in the same vein as Xanax, Valium, Darvocet is not only scientifically incorrect, but [a] real concern for limiting access to these drugs,” Avegno said.

Doctors worry that the bill could set a dangerous precedent for state officials who want to restrict access to any drug they consider dangerous or objectionable, regardless of its addictive potential, Avegno said.

Fears Over Delays in Care

In their letter opposing the reclassification, doctors said the “false perception that these are dangerous drugs” could lead to “fear and confusion among patients, doctors, and pharmacists, which delays care and worsens outcomes” in a state with high rates of maternal injury and death.

The increased scrutiny could have a statewide chilling effect and make doctors, pharmacists, and even patients more reluctant to use these drugs, the doctors wrote.

The state database allows any doctor or pharmacist to look up the prescription history of his or her patient. The data is also accessible by the Louisiana State Board of Medical Examiners, which licenses physicians and other providers, and by law enforcement agencies with a warrant.

“Could I be investigated for my use of misoprostol? I don’t know,” said Freehill, the New Orleans OB-GYN.

Pharmacists could become more reluctant to dispense the medications, Freehill said, exacerbating a problem she and other OB-GYNs have been dealing with since Louisiana banned nearly all abortions. That reluctance could lead to patients miscarrying without timely treatment.

“They could be sitting there bleeding, increasing their risk that they would have a dangerous amount of blood loss” or risking infection, she said.

Before the bill passed, Freehill routinely phoned in every prescription for misoprostol when her patients were miscarrying so she could explain to the pharmacist why she was prescribing it. Once the bill goes into effect in the fall and the drug becomes a controlled dangerous substance, that will no longer be possible because those types of prescriptions must be written on a pad or sent electronically.

In hospitals, the drugs will also have to be locked away. That could potentially cause delays getting the drug when a patient is hemorrhaging after childbirth.

Doctors worry some patients might be afraid to take the medications once they’re listed as dangerous, Avegno said.

In a written response to the Louisiana physicians who signed the protest letter, Pressly said the doctors whom he’s spoken with feel the bill “will not harm health care for women.”

Criminalizing Support for Abortions

Louisiana’s abortion ban already makes it a crime to provide an abortion, including by giving someone medications used to induce abortion. And a 2022 law added up to 50 years in prison for mailing mifepristone or misoprostol.

Because the new law explicitly exempts pregnant women, opponents like Elizabeth Ling believe it is meant to isolate those women from others who would help them. Ling, a reproductive rights attorney at If/When/How, is particularly concerned about the prison penalties, which she believes are intended to frighten and disrupt underground networks of support for patients seeking the pills.

Pregnant patients might worry about ordering online or enlisting a friend to help obtain the pills: “Is my friend who is simply just providing me emotional support going to somehow, you know, be punished for doing that?” Ling said.

Ling added that there’s concern that the law could also be used to target people who aren’t pregnant but who want to order abortion pills online and stock them in case of a future pregnancy. That practice has become increasingly popular in states with abortion bans.

This article is from a partnership that includes WWNO, NPR, and KFF Health News.

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El farmacéutico Mark Mikhael ha perdido 50 libras en los últimos 12 meses. Ya no tiene diabetes y está “en un peso corporal ideal”, con su colesterol por debajo de 200 por primera vez en 20 años. “Me siento fantástico”, dijo.

Al igual que millones de personas, Mikhael atribuye su éxito a la nueva clase de medicamentos para la pérdida de peso. Pero no está usando Wegovy o Zepbound, que son medicamentos de marca. Mikhael, director ejecutivo de Olympia Pharmaceuticals, con sede en Orlando, Florida, se ha arreglado con su propio suministro: inyectándose versiones formuladas por su empresa.

No está solo. Mikhael y otros funcionarios de la industria estiman que varias grandes farmacias de compuestos como la suya están proporcionando dosis regulares de semaglutida a hasta 2 millones de estadounidenses, el nombre científico de las formulaciones Wegovy, Ozempic y Rybelsus de Novo Nordisk, o tirzepatida, el ingrediente activo en las formulaciones Zepbound y Mounjaro de Eli Lilly.

Un compuesto es un medicamento preparado de forma personalizada en farmacias especializadas. Estas farmacias también pueden producir un fármaco génerico o de marca cuando  hay escasez.

Los gigantes de la industria de medicamentos se oponen ferozmente al negocio de compuestos.

Novo Nordisk y Lilly colocan a los fabricantes de compuestos junto con “cowboys” de internet y spas médicos no regulados que venden semaglutida falsa, y tienen feroces equipos legales tratando de detenerlos.

Novo Nordisk ha presentado al menos 21 demandas en todo el país contra empresas que fabrican supuestas copias de sus medicamentos, dijo Brianna Kelley, vocera de la empresa, e insta a los médicos a evitarlas. La Administración de Drogas y Alimentos (FDA) también ha advertido sobre el peligro potencial de los compuestos, y los principales grupos de medicina de obesidad advierten enfáticamente a los pacientes contra su uso.

Pero esto no es un mercado negro ilegal, aunque tiene matices grises.

La FDA permite e incluso fomenta que las farmacias de compuestos produzcan y vendan copias cuando un medicamento está en escasez, y los populares medicamentos GLP-1 han sido escasos por un tiempo: la semaglutida desde marzo de 2022, y la tirzepatida desde diciembre de 2022.

Estos medicamentos han mostrado un éxito sin precedentes para la pérdida de peso. También revelan promesas contra enfermedades del corazón, riñón y hígado, y se están probando contra condiciones tan diversas como el Alzheimer y la adicción a drogas.

En los últimos años, el sistema de atención médica del pais ha llegado a depender de las farmacias de compuestos, muchas de las cuales son administradas como organizaciones sin fines de lucro, para tapar los agujeros de suministro de medicamentos cruciales como los medicamentos contra el cáncer cisplatino, metotrexato y 5-fluorouracilo.

La mayoría de los medicamentos compuestos son genéricos viejos y baratos. Pero la semaglutida y la tirzepatida están bajo patente y generan miles de millones de dólares al año para Novo Nordisk y Lilly. Las ventas de los medicamentos para la diabetes y la pérdida de peso este año hicieron de Novo Nordisk la empresa más valiosa de Europa, y de Lilly la mayor compañía farmacéutica del mundo.

Mientras las empresas no pueden mantenerse al día con la demanda, disputan acaloradamente el derecho de los fabricantes de compuestos a hacer y vender copias. Kristiane Silva Bello, vocera de Lilly, dijo que su empresa estaba “profundamente preocupada” por los “graves riesgos para la salud” de los medicamentos compuestos que “no deberían estar en el mercado”.

Pero están. Incluso Hims & Hers Health, que comenzó con medicamentos para la disfunción eréctil, ahora está vendiendo semaglutida compuesta. Puso anuncios de los medicamentos durante los partidos de playoffs de la NBA. (Según un informe de Hunterbrook Media, el proveedor de semaglutida de Hims & Hers ha enfrentado escrutinio legal).

Las formas compuestas son significativamente más baratas que los medicamentos de marca. Los pacientes pagan entre $100 y $450 al mes, en comparación con los precios de lista de aproximadamente $1,000 a $1,400 para los productos de Lilly y Novo Nordisk.

Cinco fabricantes de compuestos y distribuidores entrevistados para este artículo dijeron que realizan las debidas diligencias en cada lote de semaglutida o tirzepatida que compran o producen, manteniendo estándares de pureza, esterilidad y consistencia similares a los practicados en la industria comercial de medicamentos. Los fabricantes de compuestos operan bajo estrictas normas federales y estatales, enfatizaron.

Sin embargo, las materias primas utilizadas en las formas compuestas pueden diferir de las producidas para Novo Nordisk y Lilly, dijo Jens Juul Holst, co-inventor de GLP-1 de la Universidad de Copenhague, y agregó que se debe tener cuidado en la producción de medicamentos para evitar reacciones inmunes potencialmente dañinas.

Hasta la fecha, los informes de efectos secundarios por el uso de versiones compuestas no han generado grandes alarmas, según voceros de la FDA. Pero todos los que tienen conocimiento de la industria, incluidos los propios fabricantes de compuestos, temen que un solo lote de un medicamento mal hecho podría matar o mutilar a personas, y destruir la confianza en su negocio.

“Comparo la industria de compuestos con la industria aérea”, dijo Mikhael. “Cuando ocurre un accidente aéreo, perjudica a todos”.

Advertencias del pasado

La industria sufrió una catástrofe en 2012, cuando el New England Compounding Center lanzó un esteroide inyectable contaminado que mató al menos a 64 personas e hirió a cientos más.

En respuesta, el Congreso y la FDA fortalecieron la supervisión. La empresa de Mikhael es una instalación de outsourcing, o farmacia de compuestos 503B, llamada así por una sección de la ley de 2013 que estableció nuevos requisitos para los fabricantes de compuestos.

Las empresas están autorizadas a hacer versiones ligeramente diferentes de medicamentos aprobados por la FDA en respuesta a una escasez o necesidad especiales de los pacientes.

La ley creó dos clases de farmacias de compuestos: La FDA regula los mayores fabricantes de compuestos 503B con estándares similares a las compañías de medicamentos comerciales, mientras que las farmacias 503A hacen lotes más pequeños de medicamentos y están supervisadas en gran medida por juntas farmacéuticas estatales.

Las instalaciones 503A también están produciendo semaglutida y tirzepatida compuestas para cientos de miles de pacientes. Al igual que las 503B, estas operaciones toman el ingrediente activo, producido como un polvo en fábricas registradas por la FDA, principalmente en China, y luego lo reconstituyen con agua estéril y un antimicrobiano en pequeños viales de vidrio.

En conjunto, las farmacias de compuestos pueden representar hasta el 30% de la semaglutida vendida en el país, dijo Mikhael, aunque advierte que es una “cifra aproximada” ya que nadie, incluida la FDA, está rastreando las ventas en la industria.

Los fabricantes de compuestos dicen que las empresas deberían aumentar la producción si les preocupa la competencia. Al igual que las docenas de otros medicamentos que producen para hospitales y consultorios médicos, los fabricantes de compuestos dicen que los dos medicamentos dietéticos son productos esenciales.

“Si no quieres que una instalación 503B haga una copia, es bastante simple: no tengas escasez”, dijo Lee Rosebush, presidente de una asociación comercial para farmacias 503B. “La FDA creó este sistema porque estos son medicamentos necesarios”.

Novo Nordisk no ha especificado por qué no puede mantenerse al día con la demanda, pero el cuello de botella aparentemente radica en la incapacidad de la empresa para llenar y esterilizar suficientes de sus inyectores automáticos especiales, dijo Evan Seigerman, director gerente de BMO Capital Markets.

La empresa anunció el 24 de junio que estaba invirtiendo $4.1 mil millones en nuevas líneas de producción en su sitio de Clayton, Carolina del Norte. El año pasado, la FDA emitió una advertencia por violaciones de procedimiento en el sitio y advertencias separadas en una instalación en Indiana que Novo Nordisk tomó recientemente.

Composición para tontos

Al menos 28 empresas, en su mayoría en China, están registradas ante la FDA para producir o distribuir semaglutida. Al menos la mitad de las empresas han ingresado al mercado en los últimos 12 meses, reduciendo el precio de la materia prima en un 35%, según Scott Welch, quien dirige una farmacia 503A en Arlington, Virginia.

Los fabricantes de compuestos pueden comprar semaglutida en polvo de algunos distribuidores estadounidenses por menos de $4,000 el gramo, dijo Matthew Johnson, presidente y director ejecutivo del distribuidor Pharma Source Direct. Eso resulta en tan solo $10 por dosis semanal de 2.5 microgramos.

Mientras que los pacientes de Ozempic o Wegovy usan un dispositivo de Novo Nordisk para inyectar el medicamento, los pacientes que usan productos compuestos los extraen de un vial con una pequeña aguja, como el dispositivo que usan las personas que viven con diabetes para la insulina.

Algunas prácticas médicas proporcionan el medicamento compuesto a los pacientes como parte de un paquete de pérdida de peso, con recargos. El pasado julio, Tabitha Ries, madre soltera de seis hijos que trabaja como asistente de atención médica a domicilio en Garfield, Washington, encontró una clínica en línea que le cobró $1,000 por tres meses de semaglutida junto con asesoramiento. Ha perdido 35 libras.

Obtiene el medicamento de Mindful Weight Loss, una operación principalmente basada en telemedicina dirigida por el médico Vivek Gupta de Manhattan Beach, California. Gupta dijo que ha recetado los medicamentos para la pérdida de peso a 1,500 pacientes, con aproximadamente el 60% usando versiones compuestas de una farmacia 503A.

No ha visto ninguna diferencia esencial en los pacientes que usan las formas de marca y compuestas, aunque “algunas personas dicen que el compuesto es un poco menos efectivo”, dijo Gupta.

Hay algún riesgo en usar el producto no aprobado por la FDA, reconoció, y requiere que los pacientes firmen un formulario de consentimiento informado.

“Nada en la vida está exento de riesgos, pero también argumentaría que el statu quo no es seguro para las personas que necesitan el medicamento y no pueden obtenerlo”, dijo. “Están constantemente desencadenados por toda esta comida que está causando que su peso aumente y su azúcar suba, aumentando su resistencia a la insulina y afectando sus extremidades y ojos”.

Componer semaglutida es una ayuda para los farmacéuticos como él, dijo Welch, especialmente dado el aprieto en los ingresos por la venta de medicamentos que ha llevado a muchos independientes a cerrar en los últimos años. Calcula que gana el 95% de sus ingresos con medicamentos compuestos, en lugar de recetas tradicionales.

Es importante distinguir la semaglutida compuesta de los polvos no regulados vendidos como “Ozempic genérico” y similares, que pueden estar contaminados o ser falsificados, dijo Amanda Hils, vocera de la FDA. Pero dado que las formas compuestas del medicamento no están aprobadas por la FDA, quienes las fabrican, recetan o usan también deben tener “un mayor nivel de responsabilidad o conciencia”, dijo.

Batallas corporativas

En demandas que cada empresa ha presentado contra competidores, Novo Nordisk y Lilly dicen que sus propias pruebas han encontrado bacterias y otras impurezas en productos hechos por farmacias de compuestos.

Las empresas también informan de infracción de patentes, pero los fabricantes de compuestos, señalando la laguna de la FDA para medicamentos en escasez, parecen haber derrotado ese argumento por ahora.

Cuando la FDA retira los medicamentos de la lista de escasez, los fabricantes de compuestos 503B deben dejar de venderlos de inmediato. Los fabricantes de compuestos más pequeños pueden producir sus productos para un número reducido de pacientes, dijo Scott Brunner, director ejecutivo de la Alliance for Pharmacy Compounding, que representa a los fabricantes de compuestos 503A.

Que se evaporara el suministro de medicamentos compuestos podría ser un shock para los pacientes.

“Lo temo”, dijo David Wertheimer, internista en Franklin Lakes, Nueva Jersey, que receta semaglutida compuesta a algunos pacientes. “La gente no va a poder desembolsar mil dólares cada mes. Mucha gente dejará el medicamento, y eso es una lástima”.

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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 health 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.

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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. health 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.”

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Recommendations for safer social media use for youth

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 health 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.

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A lo largo de su presidencia, Joe Biden se apoyó en Kamala Harris, la ex fiscal y senadora frontal que eligió como vicepresidenta, para ser la voz de apoyo inquebrantable de la Casa Blanca en favor de los derechos de salud reproductiva.

Ahora, mientras los demócratas reconstruyen su candidatura presidencial a pocos meses de las elecciones, se esperaría que, de ser la nueva nominada, Harris adoptase una postura agresiva en apoyo al acceso al aborto, atacando al ex presidente Donald Trump en un tema que podría socavar sus posibilidades de victoria.

Biden respaldó a Harris el domingo 21 de julio cuando anunció su decisión de retirarse de la contienda.

Aunque Biden buscaba mantener el aborto como tema central de su campaña de reelección, defensores seguían teniendo dudas de que el presidente, un católico practicante que ha dicho que no es “muy partidario del aborto”, pudiera ser un abanderado efectivo. Especialmente mientras los esfuerzos republicanos erosionan el acceso al aborto y otros servicios de salud para mujeres en todo el país.

Por otro lado, Harris se convirtió en la primera vicepresidenta en visitar una clínica operada por Planned Parenthood Federation of America. Emprendió una gira nacional centrada en los derechos reproductivos. Y cuando el senador JD Vance de Ohio fue nombrado compañero de fórmula de Trump, Harris utilizó su siguiente mitín de campaña para criticarlo por bloquear protecciones para la fertilización in vitro.

“Lo más significativo es que Harris sería el rostro del impulso para proteger el derecho al aborto”, dijo Larry Levitt, vicepresidente ejecutivo de políticas de salud en KFF, organización sin fines de lucro de información de salud de la que KFF Health News es parte, en una entrevista antes de que Biden se retirara. “El acceso al aborto probablemente sería el tema central en su campaña”.

Una postura firme sobre el aborto no es el único gran contraste con el Partido Republicano (GOP) que ofrece Harris: tiene un gran conocimiento en política de salud. De niña, a menudo acompañaba a su madre al laboratorio donde trabajaba los fines de semana, como investigadora del cáncer de mama.

Durante su campaña presidencial en 2019, apoyó el “Medicare para Todos”, una propuesta de seguro de pagador único, que estableció sus credenciales como una voz más progresista en políticas de salud. Y como fiscal general de California, luchó contra la consolidación en la industria de la salud debido a la preocupación de que esto aumentaría los precios.

En abril, defendió una norma de la administración Biden que establece niveles mínimos de personal en los hogares de adultos mayores financiados con fondos federales.

“Se merece crédito, ha hablado de estos temas en la campaña. No veo ningún cambio en las prioridades sobre lo que los demócratas quieren hacer en salud si ella se convierte en la nominada”, dijo Debbie Curtis, vicepresidenta de McDermott + Consulting.

Un enfoque intensificado en la salud de la mujer y el aborto podría ayudar a consolidar a los votantes demócratas en la recta final hacia las elecciones.

Desde que en 2022 los tres jueces de la Corte Suprema nombrados por Trump ayudaron a derogar Roe vs. Wade, la opinión pública se ha vuelto en contra de los republicanos en el tema del aborto, incluso contribuyendo a un resultado inesperadamente pobre en las elecciones intermedias de ese año.

El 32% de los votantes dijeron que solo votarían por un candidato para un cargo importante que compartiera sus opiniones sobre el aborto, según una encuesta de Gallup realizada en mayo. Ese es un récord alto desde que Gallup hizo la pregunta por primera vez en 1992. Casi el doble de votantes que apoyan el aborto, en comparación con aquellos que se oponen al aborto, tienen esa opinión.

El 63% de los adultos dijeron que el aborto debería ser legal en todos o en la mayoría de los casos, según una encuesta realizada en abril por el Pew Research Center. El 36% dijo que debería ser ilegal en todos o en la mayoría de los casos.

Mientras tanto, los republicanos han estado ansiosos por distanciarse de su propia victoria en este tema. Trump enfureció a algunos miembros de su base al decir que dejaría las decisiones sobre el aborto a los estados.

Sin embargo, defensores advierten que la nueva moderación por omisión del GOP en el tema enmascara su postura real, más extrema. Vance ha sido claro en el pasado sobre su apoyo a una prohibición nacional del aborto.

Y aunque la plataforma del GOP adoptada durante la convención del partido hace pocos días puede no pedir explícitamente una prohibición nacional del aborto, el reconocimiento de los líderes del partido de la “personalidad fetal”, la idea de que tan pronto como se fertiliza un óvulo se convierte en una persona con todos los derechos legales, crearía una prohibición automáticamente si la Corte Suprema la encontrara constitucional.

Esas opiniones contrastan con las de muchos republicanos, especialmente mujeres. Alrededor de la mitad de las votantes republicanas creen que el aborto debería ser legal en todos o en la mayoría de los casos, según una encuesta nacional reciente de KFF.

Y la mayoría de las mujeres que votan por el Partido Republicano creen que el aborto debería ser legal en casos de violación, incesto o una emergencia durante el embarazo.

Si Harris encabeza la candidatura, se esperaría que enfatice esos temas en los próximos meses.

“Ha sido uno de los temas principales, si no el principal, que ha remarcado en el último año o dos”, dijo Matthew Baum, profesor Marvin Kalb de comunicaciones globales en la Universidad de Harvard. “Claramente, los republicanos están tratando de desactivar el tema. Ha sido un desastre para ellos”.

Es probable, sin embargo, que los republicanos presenten las opiniones de Harris sobre el aborto como extremistas. Durante el debate presidencial contra Biden, Trump afirmó falsamente que los demócratas apoyan los abortos tardíos en el embarazo, “incluso después del nacimiento”.

Poco después que se diera la noticia de que Biden había respaldado a Harris, Susan B. Anthony Pro-Life America emitió un comunicado criticando el historial de Harris y ofreciendo una muestra de lo que está por venir. “Mientras Joe Biden tiene problemas para decir la palabra aborto, Kamala Harris la grita”, dijo Marjorie Dannenfelser, presidenta del grupo.

Algunos encuestadores han dicho que Harris tendrá que hacer más que simplemente hacer campaña contra los esfuerzos republicanos para revertir el acceso al aborto para realmente motivar a los votantes: temas como la inflación, la economía y la inmigración, están compitiendo por atención.

“Tiene que decir que está luchando por una ley federal que restablezca Roe vs. Wade”, dijo Robert Blendon, profesor emérito de salud pública en la Universidad de Harvard. “Necesita algo muy específico y claro”.

La elevación de Harris a la cima de la candidatura llegaría en un momento crítico en la lucha por los derechos reproductivos.

La Corte Suprema escuchó dos casos de aborto en el término que acaba de finalizar. Pero los jueces no abordaron los méritos de los temas en ninguno de los casos, fallando en su lugar sobre cuestiones técnicas. Se espera que ambos regresen a la Corte Suprema tan pronto como el próximo año.

Harris también tendría una considerable libertad para hablar sobre lo que se considera los principales logros de la política de salud de la administración Biden.

Estos incluyen mejores subsidios en la Ley de Cuidado de Salud a Bajo precio (ACA) destinados a ayudar a los consumidores a obtener seguro de salud, que se extendieron, a través de la Ley de Reducción de la Inflación, hasta 2025, el límite mensual de $35 en copagos que algunos pacientes pagan por la insulina, y la negociación de precios de medicamentos en Medicare.

“Creo que está bien posicionada. Harris es parte central de la administración y podrá atribuirse el mérito de esas cosas”, dijo Dan Mendelson, CEO de Morgan Health, una subsidiaria de J.P. Morgan Chase.

Dicho esto, puede ser difícil para cualquier candidato lograr que los votantes se enfoquen en algunos de esos logros, especialmente en los esfuerzos relacionados con los precios de los medicamentos.

Aunque la administración ha tomado algunos pasos importantes, “nuevos medicamentos costosos siguen saliendo al mercado”, dijo Mendelson. “Así que si miras la percepción de los consumidores, no creen que el costo de los medicamentos esté bajando”.

Joseph Antos, del American Enterprise Institute, dijo que es probable que Harris diga que la administración Biden-Harris “ya le está ahorrando dinero a la gente” en insulina. Pero tendrá que ir más allá de estos logros y redoblar sus esfuerzos en los precios de los medicamentos y otros temas de costo, no hablar únicamente sobre derechos reproductivos.

“Tiene que concentrarse, si quiere ganar, en temas que tengan un amplio atractivo”, dijo Antos. “El costo es uno y el acceso a tratamientos es otro gran tema”.

Samantha Young de KFF Health News contribuyó con este informe.

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.

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Throughout Joe Biden’s presidency, he leaned on the outspoken former prosecutor and senator he selected as his vice president, Kamala Harris, to be the White House’s voice of unflinching support for reproductive health rights.

Now, as Democrats rebuild their presidential ticket just a few months before Election Day, Harris would widely be expected to take an aggressive stance in support of abortion access if she became the party’s new presumptive nominee — hitting former President Donald Trump on an issue that could undermine his chances of victory. Biden endorsed Harris on Sunday when he announced his decision to leave the race.

While Biden sought to keep abortion center stage in his reelection bid, abortion advocates had harbored doubts that the president — a practicing Catholic who has said he is not “big on abortion” — could be an effective standard-bearer as Republican efforts erode access to abortion and other women’s health care around the country.

Harris, on the other hand, became the first vice president to visit a clinic run by the Planned Parenthood Federation of America. She undertook a nationwide tour focused on reproductive rights. And when Sen. JD Vance of Ohio was named Trump’s running mate, Harris used her next campaign appearance to criticize him for blocking protections for in vitro fertilization.

“Most significantly, Harris would be the face of the drive to protect abortion rights,” Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes KFF Health News, said in an interview before Biden stepped aside. “Abortion access would likely be front and center in her campaign.”

A strong stance on abortion is not the only major contrast to the GOP that Harris offers: She is well versed in health policy. As a child, Harris often accompanied her mother to work on the weekends, visiting the lab where she was studying breast cancer.

While running for president in 2019, she backed “Medicare for All,” a single-payer insurance proposal that established her bona fides as a more progressive voice on health policy. And as California’s attorney general, she fought against consolidation in the health industry over concerns it would drive up prices. 

She stumped for a Biden administration rule setting minimum staffing levels at federally funded nursing homes in April.

“She deserves credit, she’s talked about them on the campaign trail. I don’t see any change there in the priorities on what Democrats want to do on health care if she becomes the nominee,” said Debbie Curtis, vice president at McDermott + Consulting. 

An intensified focus on women’s health and abortion could help galvanize Democratic voters in the final sprint to the election. Since the three Supreme Court justices named by Trump helped overturn Roe v. Wade in 2022, public opinion has turned against Republicans on abortion, even contributing to an unexpectedly poor showing in the 2022 midterm elections.

Thirty-two percent of voters said they would vote only for a candidate for a major office who shares their views on abortion, according to a Gallup Poll conducted in May. That’s a record high since Gallup first asked the question in 1992. Nearly twice as many voters who support abortion, compared with those who oppose abortion, hold that view. 

Sixty-three percent of adults said abortion should be legal in all or most cases, based on a poll conducted in April by Pew Research Center. Thirty-six percent said it should be illegal in all or most cases.

Republicans, in turn, have been eager to distance themselves from their own victory on the issue. Trump angered some members of his base by saying he would leave decisions on abortion to the states.

Regardless, advocates caution that the GOP’s new moderation-by-omission on the issue masks their actual, more extreme stance. Vance has been clear in the past about his support for a national abortion ban. And while the GOP platform adopted during the party’s convention last week may not explicitly call for a nationwide ban on abortion, party leaders’ recognition of “fetal personhood,” the idea that as soon as an egg is fertilized it becomes a person with full legal rights, would create such a ban automatically if the Supreme Court found it constitutional.

Those views stand in contrast to those of many Republicans, especially women. About half of Republican women voters think abortion should be legal in all or most cases, according to a recent national survey by KFF. And majorities of women who vote Republican believe abortion should be legal in cases of rape, incest, or a pregnancy emergency.

If Harris heads the ticket, she would be expected to hammer on those issues in the coming months. 

“It’s been one of if not the main issue she’s emphasized in the last year or two,” said Matthew Baum, Marvin Kalb professor of global communications at Harvard University. “Clearly the Republicans are trying to defang the issue. It’s been a disaster for them.”

It is likely, though, that Republicans would paint Harris’ views on abortion as extremist. During the presidential debate against Biden, Trump falsely claimed Democrats support abortions late in pregnancy, “even after birth.”

Shortly after news broke that Biden had endorsed Harris, Susan B. Anthony Pro-Life America issued a statement calling out Harris’ record and offering evidence of what is to come. “While Joe Biden has trouble saying the word abortion, Kamala Harris shouts it,” said Marjorie Dannenfelser, the group’s president.

Some pollsters have said Harris would have to do more than just campaign against Republican efforts to roll back abortion access to truly motivate voters because so many issues, such as inflation, the economy, and immigration, are competing for attention.

“She has to say she is running for a federal law that will bring back Roe v. Wade,” said Robert Blendon, an emeritus public health professor at Harvard University. “She needs something very specific and clear.”

Harris’ elevation to the top of the ticket would come at a critical juncture in the fight over reproductive rights.

The Supreme Court heard two abortion cases in the term that ended this month. But the justices did not address the merits of the issues in either case, ruling instead on technicalities. Both are expected to return to the high court as soon as next year.

In one case, challenging the FDA’s 2000 approval of the abortion pill mifepristone, the justices ruled that the group of anti-abortion medical professionals who challenged the drug lacked standing to sue because they failed to show they were personally injured by its availability. 

But the Supreme Court returned the case to the district court in Texas where it was filed, and the GOP attorneys general of three states — Idaho, Kansas, and Missouri — have joined the case as plaintiffs. Whether the courts accept the states as viable challengers remains to be seen, but if they do, the justices could soon be asked again to determine the fate of the abortion pill.  

The other abortion-related case pitted a federal law requiring hospitals to provide emergency care against Idaho’s strict ban, which allows abortions when a pregnant patient’s life is in danger — but not in cases in which it is necessary to protect her health, including future fertility.

In that case, the justices apparently failed to reach any majority agreement, declaring instead that they were premature in accepting the case and sending it back to the lower court for further consideration. That case, too, could return in relatively short order.

Harris would also have substantial leeway to talk about what are considered to be the Biden administration’s core health policy accomplishments. These include enhanced Affordable Care Act tax credits aimed at helping consumers get health insurance coverage, which were extended through the Inflation Reduction Act into 2025, the $35 monthly cap on copays some patients pay for insulin, and drug price negotiation in Medicare.

“I think she is well positioned. She is core to the administration and will be able to take credit for those things,” said Dan Mendelson, CEO of Morgan Health, a subsidiary of J.P. Morgan Chase.

That said, it may be hard for any candidate to get voters to focus on some of those accomplishments, especially drug price efforts.

While the administration has taken some important steps, “new expensive drugs keep coming out,” Mendelson said. “So if you look at the perception of consumers, they do not believe the cost of drugs is going down.”

Joseph Antos, of the American Enterprise Institute, said Harris would likely say the Biden-Harris administration “is already saving people money” on insulin. But she will have to go beyond these accomplishments and double down on drug pricing and other cost issues — not talk solely about reproductive rights.

“She’s got to concentrate, if she wants to win, on issues that have a broad appeal,” Antos said. “Cost is one and access to treatments is another big issue.”

Samantha Young of KFF Health News contributed to this report.

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.

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A partir de septiembre, si alguien en Clemmons, Carolina del Norte, llama al 911 para pedir ayuda porque una persona está sufriendo un paro cardíaco, el primero en intervenir en la escena podrá ser un dron que lleve un Desfibrilador Externo Automático, o DEA.

“La idea es que el dron llegue varios minutos antes que los primeros socorristas”, como un técnico en emergencias médicas o una ambulancia, dijo Daniel Crews, vocero de la oficina del sheriff en el condado de Forsyth, donde se encuentra Clemmons.

La oficina del sheriff está llevando adelante este proyecto en alianza con los servicios de emergencia locales, con el Instituto de Investigación Clínica de la Universidad de Duke y con Hovecon, una empresa de consultoría en drones. “El objetivo final es evitar muertes y aumentar la esperanza de vida de quienes sufren un episodio cardíaco”, dijo Crews.

Cada vez con más frecuencia, en todo el país, las organizaciones de emergencias médicas y  las de seguridad pública están utilizando drones para acelerar la intervención en situaciones en las que cada segundo es importante para salvar vidas. El Programa del Condado de Forsyth es una de esas iniciativas.

En Estados Unidos cada año más de 356,000 personas sufren un paro cardíaco fuera de un hospital, según la Asociación Americana del Corazón (AHA). La mayoría se descompensa estando en su casa y alrededor del 90% muere porque no recibe ayuda inmediata del personal de emergencias médicas o de los transeúntes. Cada minuto que pasa sin intervención médica disminuye las probabilidades de supervivencia en un 10%.

“Nunca hemos podido alcanzar una mejora significativa en el tiempo de atención de los accidentes cardiológicos cuando se producen en entornos privados, y esta tecnología podría ayudarnos a lograr ese objetivo”, dijo Monique Anderson Starks, cardióloga y profesora asociada de Medicina en la Universidad de Duke.

Starks lidera estudios piloto en los condados de Forsyth y James City, en Virginia, que están midiendo si efectivamente la entrega de DEA con drones puede mejorar los tiempos de respuesta al tratamiento. El trabajo está financiado por una subvención de cuatro años de la AHA.

Según un trabajo de 2017, después de una llamada al 911 una unidad de servicios médicos de emergencia necesita un promedio de siete minutos para llegar al lugar. Sin embargo, los tiempos de respuesta varían considerablemente según la región. Y en el caso de las áreas rurales pueden ser muchísimo más largos.

Starks dijo que cree que los DEA entregados por drones podrían reducir el tiempo de intervención en cuatro minutos respecto de lo que tardan los primeros socorristas.

A diferencia de un ataque cardíaco, que ocurre cuando está bloqueado el flujo sanguíneo al corazón, un paro cardíaco sucede cuando este órgano deja de latir, generalmente debido a una arritmia o a un problema eléctrico. El 80% de los paros cardíacos comienzan como ataques cardíacos. La única manera de reiniciar el corazón es con resucitación cardiopulmonar (RCP) y un desfibrilador.

En el condado de Forsyth, un piloto de drones de la oficina del sheriff escuchará las llamadas al 911. Si sospecha que se está ante un paro cardíaco, el piloto puede despachar el dron incluso antes de que se contacten los servicios de emergencia médica.

El dron, que pesa 22 libras y puede viajar a 60 mph, volará hasta el lugar y se mantendrá a 125 pies de altura antes de bajar un DEA al suelo, ayudado por un dispositivo mecánico.

El DEA imparte instrucciones verbales simples y, desde su puesto, también el operador de la línea 911 podrá ayudar a usar el desfibrilador a cualquier persona sin experiencia que esté cerca. Con el tiempo se espera que haya seis bases de drones en los condados de Forsyth y James City, dijo Starks.

Sin embargo, aunque la tecnología es prometedora y la investigación a menudo ha comprobado que los drones llegan más rápido que los primeros equipos de emergencia, existe poca evidencia concluyente de que mejoren los resultados de los socorristas.

Un estudio realizado en Suecia y publicado en 2023 por The Lancet comparó los tiempos de respuesta entre drones y ambulancias para casos sospechosos de paros cardíacos en 58 intervenciones que abarcaron una población de alrededor de 200,000 personas.

El estudio llegó a la conclusión de que en el 66,67% de las ocasiones analizadas, los drones llegaron antes que las ambulancias y que esto significó que, en promedio, se anticiparon 3 minutos y 14 segundos.

En Estados Unidos, la mayoría de los programas recién están comenzando. Se está explorando el uso de drones para intervenir en casos de sobredosis de drogas, de traumas mayores y en los rescates a personas que estuvieron en riesgo de ahogarse.

En Florida, el Hospital General de Tampa, el condado de Manatee y los Sistemas de Respuesta Inmediata Archer o AFRS, iniciaron un programa en mayo para entregar DEA, torniquetes y Narcan, un spray nasal que puede revertir la sobredosis de opioides.

El programa inicialmente cubre un área de 7 millas cuadradas y los operadores de los servicios médicos de emergencia (EMS) despliegan los drones, que son monitoreados por pilotos especializados. En 2022, hubo casi 108,000 muertes por sobredosis de drogas en el país, según el Instituto Nacional sobre el Abuso de Drogas.

Hasta principios de julio, el programa de Tampa aún no había enviado ningún dron, explicó Gordon Folkes, fundador y director ejecutivo de AFRS, que desarrolla y despliega sistemas de logística de drones de emergencia.

Una solicitud recibida en junio para que enviaran un dron en un caso por sobredosis no pudo cumplirse por razones climáticas, lo impidió una tormenta violenta, dijo Folkes. En el área de prueba, que cubre aproximadamente a 7,000 residentes, Folkes estima que se podrían desplegar de 10 a 15 drones cada año.

“El punto fuerte de estos sistemas son las áreas suburbanas muy pobladas, como el condado de Manatee, porque los drones tienen la ventaja de poder evitar las congestiones de tráfico”, agregó Folkes.

Hay otros usos para los drones en emergencias médicas. El Departamento de Policía de Nueva York planea lanzar dispositivos de flotación de emergencia a los nadadores que se encuentren en problemas en las playas locales. Además, en Chula Vista, California, un dron de la policía pudo identificar la ubicación de un auto en llamas, y eso permitió que los oficiales sacaran al conductor, dijo el sargento Tony Molina.

El personal de rescate ha utilizado drones para localizar a personas que se alejan de los hogares de adultos mayores, dijo James Augustine, vocero del Colegio Americano de Médicos de Emergencia, quien es el director médico de la Asociación Internacional de Jefes de Bomberos.

En Estados Unidos, un obstáculo para los programas de drones es que la Administración Federal de Aviación (FAA) generalmente requiere que los drones sean manejados dentro de la línea de visión de los operadores. En mayo, cuando el Congreso aprobó la ley de reautorización de la FAA, se le otorgó un plazo de cuatro meses para emitir una propuesta de reglamentación sobre las operaciones de drones más allá de la línea de visión.

“La FAA se está concentrando en desarrollar reglas estándar para hacer que las operaciones (más allá del campo visual) sean rutinarias, y económicamente viables”, dijo Rick Breitenfeldt, vocero de la FAA.

Por otro lado, algunos grupos de libertades civiles están preocupados porque las nuevas reglas de la FAA no proporcionen suficiente protección contra las cámaras de los drones para las personas en tierra.

Jay Stanley, analista de políticas senior de la Unión Americana de Libertades Civiles, reconoció los beneficios de usar drones en situaciones de emergencia pero consideró que aún hay problemas que deben abordarse.

“La preocupación es que la FAA va a flexibilizar significativamente las restricciones a los drones sin ninguna protección significativa de la privacidad”, expresó.

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.

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This story can be republished for free (details).