Home » Archive for Juli 2024

Copycat Weight-Loss Drugs Are Major Players With Consumers

As many as 1 in 8 American adults has tried one of the GLP-1 anti-obesity drugs, but a surprising number aren’t getting their supplies from pharma giants Novo Nordisk or Eli Lilly. Up to 30 percent of the market, by some estimates, is made up of copycat versions from compounding pharmacies.

Compounding is legal, though the resulting products sometimes fall into a gray area because they’re copies of drugs under patent and are not approved by the Food and Drug Administration.

Mark Mikhael, CEO of Orlando-based Olympia Pharmaceuticals, estimates that his and other large compounders provision up to 2 million Americans each month with 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.

Many of the compounded drugs are produced for and sold by online pharmacies like Hims & Hers Health, Henry Meds and Ro. Others come from smaller compounding companies.

Novo Nordisk and Lilly fiercely oppose these sales and lump the compounders together with unregulated medical spas peddling bogus semaglutide. 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.

When there’s a drug shortage — the FDA has put semaglutide and tirzepatide on shortage lists since 2022 — the agency allows compounders to make it. The compounding companies get raw material for the drugs from mostly Chinese businesses that are registered and, at least in theory, inspected by the FDA.

Because the drugs are not strictly FDA-approved, those who make, prescribe or take them should exercise “an increased level of responsibility or awareness,” FDA spokesperson Amanda Hils said.

But she distinguished the compounded drugs from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit. The agency recently warned about patients taking the wrong doses of the compounds, but it hasn’t received a disproportionate number of side effect reports linked to these drugs.

Semaglutide and tirzepatide have registered unprecedented success in weight loss. They are also showing promise against heart, kidney and liver diseases, and are being tested to treat or prevent Alzheimer’s disease and drug addiction. It’s no wonder they are in shortage.

While most compounded drugs are copies of old, cheap generics, semaglutide and tirzepatide are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Compounded forms are cheaper, particularly for patients whose insurers won’t cover the branded drugs.

While the pharmaceutical giants can’t keep up with demand, they 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.”

Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — regulated directly by the FDA. Smaller 503A pharmacies are largely overseen by state boards of pharmacy.

The compounders are defiant, calling the diabetes and diet drugs 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.”

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

It’s a Bird. It’s a Plane. It’s a Medical Response Drone.

What if the first responder on the scene of a cardiac arrest were a drone carrying an automated external defibrillator?

When every second counts, public safety professionals are increasingly eyeing drones — which can fly 60 miles an hour and don’t get stuck in traffic — to deliver help faster than an ambulance or EMT.

Starting in September, 911 callers in Clemmons, N.C., may see a drone winging its way to those suffering a cardiac arrest. Under a pilot program operated jointly by the Forsyth County Sheriff’s Office, local emergency services, the Clinical Research Institute at Duke University and drone consulting firm Hovecon, drone pilots from the sheriff’s department will monitor 911 calls and dispatch drones.

The sheriff’s office has approval from the Federal Aviation Administration to operate within a 2-mile radius of the launch site, beyond the visual line of sight. Upon arrival, a drone will hover 125 feet above the caller’s location and lower an AED complete with verbal instructions.

“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 an associate professor of medicine at Duke, who is leading the program. It will eventually operate six drones at six sites in Forsyth County and James City County, Va., that can deliver AEDs, she said.

It’s a critical problem. More than 356,000 people suffer cardiac arrests outside of a hospital setting every year in the United States. About 90 percent die, because they don’t get immediate help. Every minute that passes without medical intervention decreases survival odds by 10 percent.

In the United States, emergency medical services take an average of seven minutes to arrive after a 911 call, one study found, but the time varies considerably by region.

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

Drones are being tested in other types of medical emergencies, too. In Florida, Tampa General Hospital, Manatee County and Archer First Response Systems began a program in May to deliver not only AEDs by drone but also tourniquets and Narcan, the nasal spray that can reverse an opioid overdose. The program currently operates in a 1.5-mile radius, within visual line of sight.

In New York City, the police department plans to use drones to drop emergency flotation devices to struggling swimmers at local beaches. Emergency rescuers elsewhere have used drones to locate people who wander away from nursing homes.

One hurdle to these programs spreading has been the FAA’s usual requirement that these airborne devices be used within their operators’ visual line of sight. In May, when Congress passed the FAA reauthorization bill, it gave the FAA four months to issue a proposed rule spelling out requirements for operating 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 spokesman.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

Readers Weigh In on the Abortion Debate and Ways To Tackle the Opioid Crisis

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Debunking Abortion Myths

I want to send a big THANK YOU to Matt Volz for writing a fact-checking article on the nonsense rhetoric around “abortion up until and after birth” that has run wild and unchallenged in the media (“GOP’s Tim Sheehy Revives Discredited Abortion Claims in Pivotal Senate Race,” July 9). Thanks for putting abortion later in pregnancy in context and debunking false assumptions.

I am a near-third-trimester abortion patient (nonviable pregnancy, terminated at 26 weeks), and I am so sick of hearing politicians like Tim Sheehy talk about something they have never experienced or bothered to learn about. It is as though I am watching the entire nation maliciously gossip about me and other parents like me. Those of us in the termination for medical reasons (TFMR) community have walked through hell only to have our voices, at best, be ignored or, more commonly, be insulted and threatened.

And I imagine watching this political circus is just as hurtful for parents who lost an infant shortly after birth and had to provide palliative care. That is who they are talking about with “abortion after birth”; they are talking about comfort care for infants who will not survive.

Thank you again for bringing a dose of reality to a conversation that never should have become political. These are impossible decisions that only parents should make. It was really refreshing to read Volz’s article and know that some journalists are still willing to fact-check the absurd claims floating around. It was encouraging to know that someone does see us.

— Anne Angus, Bozeman, Montana

A physician and Yale professor of radiology and biomedical imaging took to the social platform X to share feedback:

.@SenatorTester is a great Senator. And his opponent is a great liar. Both the GOP presidential candidate and Tim Sheehy have perpetuated this lie. Please push back every time you hear it. https://t.co/1LBGPgOA2u
— (((Howard Forman))) (@thehowie) July 9, 2024

— Howard Forman, New Haven, Connecticut

I just read your article at PolitiFact on Republican Senate candidate Tim Sheehy’s statement about abortion, and I would like to point out (what I believe) are a couple of errors.

1. In paragraph 10, you quote KFF’s Alina Salganicoff saying that “in the good-faith medical judgment of the treating health care provider, continuation of the pregnancy would pose a risk to the pregnant patient’s life or health.” Now, you may know that almost at the same time that the Roe v. Wade decision was released, there was a decision called Doe v. Bolton that interpreted “health” to mean almost anything. That broad interpretation of health is found in your article in paragraph 24: “Women have abortions later in pregnancy either because they find out new information or because of economic or political barriers,” [Katrina] Kimport said.

When a woman can have an abortion after viability because she offers any reason that can be interpreted as “health,” then abortion would be legal throughout all nine months of pregnancy. I believe that you are wrong in your interpretation. Democrats do not want to name any restriction on abortion during all nine months, and every mention of “health” is a fig leaf that does not restrict abortion at all. Every abortion advocate knows that.

2. Whether late-term abortions are rare or not is logically irrelevant to whether late-term abortions should be restricted.

Why don’t you know these things?

— Darryl A. Linde, Tahlequah, Oklahoma

An Air Force veteran added his two cents on X:

Dems have the facts. Republicans spread fear and lies.https://t.co/6CWfKhqxJZ
— James Knight (@jamesUSAF_vet) July 12, 2024

— James Knight, Reno, Nevada

Making a Healthy Difference for the Homeless

Thank you for printing this story (“A California Medical Group Treats Only Homeless Patients — And Makes Money Doing It,” July 19). It really piqued my interest and portrayed a positive solution for getting care to the people.

Up here in the Bay Area, I believe there are a couple of groups who go out and find what needs doing instead of waiting for people to come to them — but nothing like this. Makes me curious about what we actually have going on here.

— Laurie Lippe, El Cerrito, California

A self-described “nurse turned health tech nerd” commended the effort on X:

"They distribute GPS devices so they can track their homeless patients. They keep company credit cards on hand in case a patient needs emergency food or water, or an Uber ride to the doctor"This is healthcare at its best 💕https://t.co/UhM1dgTPH7
— Rik Renard (@rikrenard) July 22, 2024

— Rik Renard, New York City

A senior policy director at the National Health Care for the Homeless Council shared the post on X — while stressing that her tweets reflected her own opinions and not those of her organization:

I’m with ⁦@DrJimWithers: “I do worry about the corporatization of street medicine and capitalism invading what we’ve been building, largely as a social justice mission outside of the traditional health care system.” https://t.co/IOjazvrvqP
— Barbara DiPietro (@BarbaraDiPietro) July 19, 2024

— Barbara DiPietro, Baltimore

On X, a physician who says she champions “physicians, patients, public health, and the patient-physician relationship” reacted to our coverage surrounding the Federal Trade Commission’s rule banning the use of noncompete agreements in employment contracts:

FTC #noncompete crackdown may not protect doctors and nurses at ~64% of US community hospitals that are tax-exempt nonprofits or government-owned.But, ⁦@FTC⁩ said some nonprofits could be bound by the rule if they do not operate as true charities. https://t.co/9fDbfVflTH
— Marilyn Heine (@MarilynHeineMD) May 28, 2024

— Marilyn Heine, Langhorne, Pennsylvania

Without a Noncompete Ban on All Employers, Rural Access to Care Suffers

When news broke that the Federal Trade Commission would be banning noncompete agreements in employment contracts, many of us in the medical profession celebrated. However, until nonprofit hospitals and health care facilities benefit from the same ban, access to care — particularly in rural regions — will suffer.

As reported in “Health Worker for a Nonprofit? The New Ban on Noncompete Contracts May Not Help You” (June 5), about two-thirds of U.S. community hospitals are nonprofit or government-owned. This means that most hospitals nationwide may continue to enforce noncompete agreements among their employees, a practice that will have an outsize impact on rural medical professionals.

As a rheumatologist in a rural area, I’ve seen how detrimental limited access to care is for patients. Noncompete agreements serve only to further limit access to much-needed care. Due to the physician shortage being particularly acute in rural America, there are oftentimes only a few specialty physicians servicing a large region. Suppose one of these specialists is employed by a large health system and wants to transition to a private practice. It reduces the number of accessible specialists in the area when their noncompete agreement prohibits them from practicing near any of the health care facilities associated with the system. And increasing consolidation across health care means many rural regions may have only a single health system that operates across the entire state and surrounding areas. A geographically limiting noncompete agreement essentially stops a physician or medical professional from practicing entirely in the area, or they must uproot their life and move away from the major health system.

I hope the FTC takes further action to include nonprofit health care employers in its noncompete ban. I also urge nonprofit employers to consider their rural patients’ access to care when requiring providers to sign noncompete agreements. It’s in the best interest of our patient’s health to get rid of these agreements entirely.

— Chris Phillips, chair of the American College of Rheumatology’s Committee on Rheumatologic Care, Paducah, Kentucky

The president of the Texas Medical Board also posted on X with feedback:

Is it a coincidence that this affects everyone, except those who work for nonprofit hospitals and health care facilities, which employs the largest number of medical professionals?The FTC and it's selective enforcement and rules is blatantly obvious! https://t.co/RzXInqiJ8D
— Sherif Zaafran, MD (@szaafran) June 16, 2024

— Sherif Zaafran, Houston

Repurposing Newspaper Boxes for Public Health

I recently read your article by Mara Silvers regarding the state’s intended use of public health vending machines (PHVMs) to help fight the opioid overdose epidemic (“Montana’s Plan To Curb Opioid Overdoses Includes Vending Machines,” July 18). Working on the covid-19 response for almost four years now, and with our American Rescue Plan Act funding coming to an end, we recently used a byline in our equipment budget to purchase and place “resource kiosks” in the community.

In 2022, after researching the use of vending machines for test distribution, we discovered vending machines have high barrier-to-entry costs and high maintenance costs. And even if purchasing isn’t possible, rental contracts come with high fees. We decided it was better to use a lower-cost resource that could be purchased in greater quantity, easily placed with community partners, and required no maintenance: the refurbished newspaper kiosk.

We decided to purchase double-decker boxes, which have a secondary door, creating another shelf, for roughly $410 apiece and stocked them with covid tests, nasal naloxone, injectable naloxone, fentanyl test strips, xylazine test strips, various types of condoms, and lubrication packets. We are in the process of securing a supply of gun locks and adding links to our pilot landing page for individual free gun lock deliveries, as well as links for free sexually transmitted infection test kits. We have investigated providing dental supplies and other items, but long-term funding is a constant concern. Grant money for most programs (likely all ARPA dollars) is running out, so the viability of these types of pilot programs is tentative without a buy-in from state or federal agencies.

Mara’s article hinted at criteria for possible placements and, similarly, we didn’t use locational overdose data, which can be “othering” to communities, but instead placed these kiosks with community partners that have been accomplished supporters of their at-risk populations throughout the covid response. Each community partner helped protect the communities they served through increased access to resources and provided information as trusted messengers. Truly meeting people where they are.

While money quickly appeared to fight the covid pandemic, and states spirited away dollars for pet projects, that sea of funding has dried up, and there doesn’t seem to be a plan for any continued funding. Covid-related functions have all been folded back into communicable disease epidemiology programs, which were already underfunded; in our state, the money funding the naloxone bulk fund is also drying up. Covid deaths might be down, but there is always a new bug (H5N1), STI infections are up, and gun-related deaths grow year over year. Funding population-level health interventions is our next pandemic.

With enough funding, kiosk-sized PHVMs could be swiftly added to any public health agency’s or community program’s quiver of tools to help increase access to resources and information for the most vulnerable residents.

Thank you for publishing a great article about the emerging opportunities to respond to changing public health needs!

— Christopher Howk, Arapahoe County Public Health’s covid-19 testing and logistics coordinator, Greenwood Village, Colorado

A retiree with a PhD in quantum chemistry tweeted his surprise over the news:

Montana’s Plan To Curb Opioid Overdoses Includes Vending Machineshttps://t.co/kNxYjnIOEO(What???!! Vending machines for opioids?)
— John Lounsbury (@jlounsbury59) July 18, 2024

— John Lounsbury, Lake Frederick, Virginia

Misappropriation of Opioid Settlement Funds

OK, so I see how all these states got all these lump sums of money for people like us who became addicted and whose lives were devastated by Purdue Pharma, Vicodin, and all the pharmacies (“Lifesaving Drugs and Police Projects Mark First Use of Opioid Settlement Cash in California,” July 12). How come all these states got all the money but those of us who have suffered have to wait, hire lawyers, and wait years for the money that was just handed over to these states? We’re the ones whose lives were devastated. My son was hooked, I was hooked, and my wife, and yet we must sit here penniless after the addiction, while all these states take the money — and they don’t do what they’re supposed to with it, and everyone knows it.

— Michael Stewart, Des Moines, Iowa

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

Why Many Nonprofit (Wink, Wink) Hospitals Are Rolling in Money

One owns a for-profit insurer, a venture capital company, and for-profit hospitals in Italy and Kazakhstan; it has just acquired its fourth for-profit hospital in Ireland. Another owns one of the largest for-profit hospitals in London, is partnering to build a massive training facility for a professional basketball team, and has launched and financed 80 for-profit start-ups. Another partners with a wellness spa where rooms cost $4,000 a night and co-invests with “leading private equity firms.”

Do these sound like charities?

These diversified businesses are, in fact, some of the country’s largest nonprofit hospital systems. And they have somehow managed to keep myriad for-profit enterprises under their nonprofit umbrella — a status that means they pay little or no taxes, float bonds at preferred rates, and gain numerous other financial advantages.

Through legal maneuvering, regulatory neglect, and a large dollop of lobbying, they have remained tax-exempt charities, classified as 501(c)(3)s.

“Hospitals are some of the biggest businesses in the U.S. — nonprofit in name only,” said Martin Gaynor, an economics and public policy professor at Carnegie Mellon University. “They realized they could own for-profit businesses and keep their not-for-profit status. So the parking lot is for-profit; the laundry service is for-profit; they open up for-profit entities in other countries that are expressly for making money. Great work if you can get it.”

Many universities’ most robust income streams come from their technically nonprofit hospitals. At Stanford University, 62% of operating revenue in fiscal 2023 was from health services; at the University of Chicago, patient services brought in 49% of operating revenue in fiscal 2022.

To be sure, many hospitals’ major source of income is still likely to be pricey patient care. Because they are nonprofit and therefore, by definition, can’t show that thing called “profit,” excess earnings are called “operating surpluses.” Meanwhile, some nonprofit hospitals, particularly in rural areas and inner cities, struggle to stay afloat because they depend heavily on lower payments from Medicaid and Medicare and have no alternative income streams.

But investments are making “a bigger and bigger difference” in the bottom line of many big systems, said Ge Bai, a professor of health care accounting at the Johns Hopkins University Bloomberg School of Public Health. Investment income helped Cleveland Clinic overcome the deficit incurred during the pandemic.

When many U.S. hospitals were founded over the past two centuries, mostly by religious groups, they were accorded nonprofit status for doling out free care during an era in which fewer people had insurance and bills were modest. The institutions operated on razor-thin margins. But as more Americans gained insurance and medical treatments became more effective — and more expensive — there was money to be made.

Not-for-profit hospitals merged with one another, pursuing economies of scale, like joint purchasing of linens and surgical supplies. Then, in this century, they also began acquiring parts of the health care systems that had long been for-profit, such as doctors’ groups, as well as imaging and surgery centers. That raised some legal eyebrows — how could a nonprofit simply acquire a for-profit? — but regulators and the IRS let it ride.

And in recent years, partnerships with, and ownership of, profit-making ventures have strayed further and further afield from the purported charitable health care mission in their community.

“When I first encountered it, I was dumbfounded — I said, ‘This not charitable,’” said Michael West, an attorney and senior vice president of the New York Council of Nonprofits. “I’ve long questioned why these institutions get away with it. I just don’t see how it’s compliant with the IRS tax code.” West also pointed out that they don’t act like charities: “I mean, everyone knows someone with an outstanding $15,000 bill they can’t pay.”

Hospitals get their tax breaks for providing “charity care and community benefit.” But how much charity care is enough and, more important, what sort of activities count as “community benefit” and how to value them? IRS guidance released this year remains fuzzy on the issue.

Academics who study the subject have consistently found the value of many hospitals’ good work pales in comparison with the value of their tax breaks. Studies have shown that generally nonprofit and for-profit hospitals spend about the same portion of their expenses on the charity care component.

Here are some things listed as “community benefit” on hospital systems’ 990 tax forms: creating jobs; building energy-efficient facilities; hiring minority- or women-owned contractors; upgrading parks with lighting and comfortable seating; creating healing gardens and spas for patients.

All good works, to be sure, but health care?

What’s more, to justify engaging in for-profit business while maintaining their not-for-profit status, hospitals must connect the business revenue to that mission. Otherwise, they pay an unrelated business income tax.

“Their CEOs — many from the corporate world — spout drivel and turn somersaults to make the case,” said Lawton Burns, a management professor at the University of Pennsylvania’s Wharton School. “They do a lot of profitable stuff — they’re very clever and entrepreneurial.”

The truth is that a number of not-for-profit hospitals have become wealthy diversified business organizations. The most visible manifestation of that is outsize executive compensation at many of the country’s big health systems. Seven of the 10 most highly paid nonprofit CEOs in the United States run hospitals and are paid millions, sometimes tens of millions, of dollars annually. The CEOs of the Gates and Ford foundations make far less, just a bit over $1 million.

When challenged about the generous pay packages — as they often are — hospitals respond that running a hospital is a complicated business, that pharmaceutical and insurance execs make much more. Also, board compensation committees determine the payout, considering salaries at comparable institutions as well as the hospital’s financial performance.

One obvious reason for the regulatory tolerance is that hospital systems are major employers — the largest in many states (including Massachusetts, Pennsylvania, Minnesota, Arizona, and Delaware). They are big-time lobbying forces and major donors in Washington and in state capitals.

But some patients have had enough: In a suit brought by a local school board, a judge last year declared that four Pennsylvania hospitals in the Tower Health system had to pay property taxes because its executive pay was “eye popping” and it demonstrated “profit motives through actions such as charging management fees from its hospitals.”

A 2020 Government Accountability Office report chided the IRS for its lack of vigilance in reviewing nonprofit hospitals’ community benefit and recommended ways to “improve IRS oversight.” A follow-up GAO report to Congress in 2023 said, “IRS officials told us that the agency had not revoked a hospital’s tax-exempt status for failing to provide sufficient community benefits in the previous 10 years” and recommended that Congress lay out more specific standards. The IRS declined to comment for this column.

Attorneys general, who regulate charity at the state level, could also get involved. But, in practice, “there is zero accountability,” West said. “Most nonprofits live in fear of the AG. Not hospitals.”

Today’s big hospital systems do miraculous, lifesaving stuff. But they are not channeling Mother Teresa. Maybe it’s time to end the community benefit charade for those that exploit it, and have these big businesses pay at least some tax. Communities could then use those dollars in ways that directly benefit residents’ health.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

Montana Looks To Become Latest State To Boost Nonprofit Hospital Oversight

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

Louisiana Reclassifies Drugs Used in Abortions as Controlled Dangerous Substances

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

El plan de Montana para frenar las sobredosis de opioides incluye máquinas expendedoras

Antes de dejar de usar drogas para siempre, Cierra Coon estima que sufrió ocho sobredosis en un lapso de dos semanas, en el otoño de 2022. En una de esas ocasiones, la naloxona, el medicamento para revertir la sobredosis de opioides, ayudó a salvarle la vida.

Coon estaba en un auto por los caminos secundarios de la Reserva India Flathead en el oeste de Montana cuando perdió el conocimiento. Alguien en el auto tomó una pequeña botella de naloxona, la roció en su nariz y realizó resucitación (CPR) hasta que recuperó el conocimiento.

Coon dijo que tener acceso rápido al agente de reversión de sobredosis, también conocido por su nombre comercial, Narcan, fue muy afortunado.

“Es un milagro que haya sobrevivido las veces que no me administraron naloxona”, dijo Coon. “La gente me devolvió la conciencia echándome agua fría y haciendo CPR. Pero eso no garantiza que te vayan a devolver a la vida”, agregó Coon.

Casi dos años después, Coon es entrenadora de recuperación para un programa local, Never Alone Recovery Support Services, y está obteniendo un título como consejera de adicciones en Salish Kootenai College. Lleva dosis de naloxona en su auto por si necesita ayudar a otras personas.

Pero dijo que le preocupa la falta de acceso al medicamento, particularmente en áreas rurales como la suya. El canal de distribución de los departamentos de salud estatal y tribal ha sido inconsistente, y el precio de $50 por un paquete de dos dosis de naloxona en el Walmart más cercano lo vuelve inaccesible para muchas personas.

“¿Cómo se supone que vamos a poder pagar por este medicamento que en última instancia es para salvar nuestras vidas y las de los que nos rodean?” dijo.

Oficiales de salud de Montana están considerando una nueva estrategia para hacer que la naloxona sea más accesible.

Basándose en un fondo de salud conductual reservado por los legisladores en 2023, oficiales de salud de la administración del gobernador Greg Gianforte han propuesto instalar dos docenas de máquinas expendedoras de naloxona y tiras reactivas de fentanilo alrededor del estado, en centros de salud conductual y lugares de servicio para personas sin hogar.

El plan de $400,000 para construir, abastecer y mantener 24 máquinas expendedoras durante un año aún no ha sido aprobado por el gobernador republicano, que se postula para un segundo mandato, quien en última instancia decide cómo se gastan los fondos asignados a la Comisión del Sistema de Salud Conductual para las Generaciones Futuras.

Los detalles del Departamento de Salud Pública y Servicios Humanos del estado sobre dónde se colocarían las máquinas y cómo se operarían siguen siendo escasos.

La tasa de muertes relacionadas con opioides se ha triplicado en Montana en los últimos años, de 3,6 muertes por cada 100,000 residentes en 2017 a 11,3 por cada 100,000 residentes en 2023.

La tasa de mortalidad es más alta entre los nativos americanos: las personas nativas en Montana murieron por sobredosis de opioides a una tasa de 33 muertes por cada 100,000 personas en 2023, más de tres veces la tasa de las personas blancas no hispanas.

La naloxona ha surgido como una herramienta importante para combatir las sobredosis de opioides. Cuando se administra rápidamente, se adhiere a los receptores del cerebro a los que se dirigen los opioides, bloqueando los efectos de las drogas.

En todo Estados Unidos, las máquinas expendedoras que distribuyen naloxona y otros suministros de salud de forma gratuita se están convirtiendo en elementos de primera línea en la lucha contra las sobredosis de opioides. Diferentes versiones del modelo se están probando en al menos 33 estados.

En un informe de 2023, el Consejo Nacional para el Bienestar Mental describió el uso de máquinas expendedoras para distribuir naloxona y otros suministros de “reducción de daños”, como kits de primeros auxilios, pruebas de embarazo, jeringas estériles y más, como una herramienta de salud pública que se hizo más común durante la era del distanciamiento social durante la pandemia de covid-19.

Pero la popularidad del modelo ha seguido creciendo desde entonces, especialmente en lugares con poblaciones a las que es difícil llegar.

“Proporcionan servicios a [personas que usan drogas] con muchas menos barreras que los programas en un sitio fijo e incluso la divulgación móvil”, afirmó el informe. Las máquinas expendedoras de reducción de daños “también pueden proporcionar mayor privacidad y anonimato”.

La propuesta del departamento de salud estatal sería el primer caso en Montana de máquinas expendedoras financiadas directamente por el estado, a diferencia de las pocas que ahora se financian a través de subvenciones públicas o filantropía privada.

Jami Hansen, jefe de la oficina de prevención de la División de Salud Conductual y Discapacidades del Desarrollo del departamento, habló sobre la propuesta durante una reunión de mayo de la comisión estatal de salud conductual. Dijo que las máquinas expendedoras son una forma específica de llenar vacíos en un estado escasamente poblado que no ofrece acceso consistente a tratamientos para la adicción y naloxona.

“Tener algo disponible que puedan utilizar ellos mismos sería muy, muy beneficioso”, agregó Hansen.

Algunos grupos locales de salud pública en Montana, incluidos los de Missoula, Helena, Kalispell y el condado de Big Horn, ya han comenzado a usar máquinas expendedoras para distribuir naloxona gratuita, tiras reactivas para drogas y otros suministros de salud.

En Helena, tres máquinas compradas por el condado de Lewis y Clark han estado distribuyendo aerosol nasal Narcan gratuito y bolsas para la eliminación segura de drogas (usadas para disolver pastillas recetadas y recreativas) durante más de un año.

Kellie Goodwin McBride, directora del departamento de servicios de justicia penal del condado, dijo que su equipo intentó inicialmente integrar las máquinas en negocios locales, como un bar céntrico, una lavandería y un mercado, pero fallaron repetidamente.

A veces, no había suficiente espacio para las máquinas. En otros casos, dijo McBride, los dueños se preocupaban de que una máquina expendedora de Narcan diera la impresión de que el negocio toleraba o acogía el uso de drogas.

En su lugar, el condado instaló máquinas expendedoras en un refugio sin fines de lucro que atiende a residentes locales sin hogar, el edificio del tribunal de distrito estatal y el Centro de Justicia y Leyes en el centro, que alberga el tribunal municipal y el departamento del sheriff del condado. Esa máquina, es la que más se utiliza, dijo McBride.

A diferencia de algunos otros modelos, las máquinas expendedoras de Narcan en Helena no requieren registro de usuarios ni códigos para acceder a los materiales dentro, lo que hace imposible rastrear quién está tomando naloxona o si se está utilizando.

McBride y su equipo reconocen que no hay una forma consistente de saber cuántas muertes relacionadas con opioides han ayudado a prevenir las máquinas expendedoras.

Jessica Johnson es la supervisora de educación sanitaria en el Distrito de Salud del Sur de Nevada, que ayudó a crear la primera colaboración de máquinas expendedoras en el país. Dijo que el proyecto fue diseñado para distribuir naloxona y jeringas estériles para reducir la propagación de enfermedades infecciosas entre las personas que se inyectan drogas.

Un estudio de 2022 registró 41 muertes por sobredosis menos de las esperadas en el condado de Clark, donde se ubicaron las máquinas, durante el primer año de distribución.

Johnson dijo que una de sus conclusiones del programa es la importancia de escuchar a las personas que están en más riesgo de la comunidad. Los quioscos o máquinas expendedoras de reducción de daños resultantes pueden ser tan diversos como los lugares en los que se encuentran.

Trabajadores de salud pública de todo el país han agregado cepillos de dientes, kits para dejar de fumar tabaco y otros suministros a sus máquinas expendedoras según las sugerencias de las poblaciones a las que sirven, dijo Johnson.

Aunque aún no se han elegido a los organizadores, Jon Ebelt, vocero del departamento de salud de Montana, dijo que la recomendación de la agencia de colocar máquinas en refugios y sitios que atienden a personas sin hogar se basa en el deseo de llegar a personas con enfermedades mentales graves, y a otras que ya están buscando servicios en esos lugares.

Ebelt confirmó que el departamento no se basó en datos de sobredosis de opioides ni en información demográfica sobre las personas que más a menudo sufren sobredosis en Montana al decidir dónde colocar las máquinas. En su lugar, la decisión se basó en “programación comunitaria y contratos existentes con sitios de servicios de salud mental y adicciones”.

Agregó que, según la propuesta, los anfitriones comunitarios de las máquinas expendedoras podrán seleccionar muchos tipos de suministros adicionales de reducción de daños para distribuir, “ya que cada comunidad tiene diferentes necesidades”, pero las jeringas estériles no estarán entre los productos disponibles en las máquinas de Montana.

El estado planea pagar un año de suministros, después del cual puede utilizar subvenciones federales para abastecer las máquinas, y los fondos federales no pueden utilizarse para comprar jeringas para el uso ilegal de drogas. Ebelt no respondió a otras preguntas sobre esa decisión o si los sitios podrían agregar jeringas y otros materiales suministrados a través de financiación independiente.

Este artículo se produjo a través de una asociación entre KFF Health News y Montana Free Press.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

Qué son los medicamentos compuestos que millones de personas usan para bajar de peso

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”.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

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

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.”

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

Rescate desde el cielo: cómo los drones pueden reducir el tiempo de respuesta a una emergencia

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.

USE OUR CONTENT

This story can be republished for free (details).

from Health Industry Archives - KFF Health News

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts:

USE OUR CONTENT

Related Posts: