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As Low-Nicotine Cigarettes Hit the Market, Anti-Smoking Groups Press for Wider Standard

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by Don Thompson
Fri, 30 Jun 2023 09:00:00 +0000

The idea seems simple enough.

Preserve all the rituals of smoking: Light up a cigarette, inhale the smoke, the nasty stuff that can kill you, and exhale. But most of the nicotine, the chemical that makes tobacco so darn hard to quit, to smokers smoke less.

The Food and Drug Administration has been contemplating that strategy for at least six years as one way to make it easier for smokers to cut back, if not quit entirely. Less than two years ago, it authorized 22nd Century Group, a publicly traded plant biotech company based in Buffalo, New York, to advertise its proprietary low-nicotine cigarettes as modified-risk tobacco products.

Now, the first authorized cigarettes with 95% less nicotine than traditional smokes are coming to California, Florida, and in early July, after a year of test-marketing in Illinois and Colorado. It’s part of an aggressive rollout by 22nd Century that, by year’s end, could bring its products to 18 states — markets that together account for more than half of U.S. cigarette sales.

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But anti-smoking groups oppose greenlighting 22nd Century’s products. Instead, they urge federal regulators to expand on their original plan of setting a low-nicotine standard for all combustible cigarettes to make them minimally or nonaddictive. They expect the FDA to take the next step in that industrywide regulatory process as early as this fall.

“Unless and until there is a categorywide requirement that nicotine goes down to low, nonaddictive levels, this is not going to make a difference,” said Erika Sward, a spokesperson for the American Lung Association.

Major tobacco companies Altria, R.J. Reynolds, and ITG Brands did not respond to requests for comment.

Cigarette smoking is estimated to cause more than 480,000 deaths a year in the U.S., including from secondhand smoke, and contributes to tobacco use being the leading preventable cause of death nationally. In 2018, then-FDA Commissioner Scott Gottlieb wrote that setting a maximum nicotine level “could result in more than 8 million fewer tobacco-caused deaths through the end of the century – an undeniable public benefit.”

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The FDA reasoned that people would collectively smoke fewer cigarettes and have less exposure to the deadly toxins that are still present in low-nicotine cigarettes.

22nd Century says it used a patent-protected process to control nicotine biosynthesis in the tobacco plant, enabling it to create a pack of cigarettes with about as much nicotine as one Marlboro. It says generally that it uses “modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding.”

Keeping 5% of the nicotine is enough to prevent smokers from seeking more to satisfy their craving, said John Miller, president of 22nd Century’s smoking division.

“There’s just enough in there that your brain thinks it’s getting it, but it’s not,” Miller said. “That was really one of the reasons we got to these levels of nicotine, is because you don’t have that additional smoking.”

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Miller said the low-nicotine cigarettes can help some smokers cut back or quit, perhaps in conjunction with a nicotine patch or gum, when they’ve tried and failed with other stop-smoking programs.

Campaign for Tobacco- Kids President Matthew L. Myers supports the of an industrywide low-nicotine standard, saying the concept would work only if consumers no longer had the alternative of a higher-nicotine cigarette.

“The concern with a product that’s still addictive, but delivers low levels of nicotine, in fact is that consumers will smoke more, because the evidence shows that somebody who’s addicted will smoke enough to satisfy their craving,” Myers said.

Both the FDA and anti-smoking groups cited studies that found lower levels of nicotine don’t prompt smokers to smoke more to reach the same nicotine levels. But those studies assumed smokers wouldn’t have a high-nicotine alternative, anti-smoking groups and researchers said.

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Allowing low-nicotine cigarettes while conventional cigarettes remain available may be a public health detriment if they discourage smokers from quitting entirely or encourage others to start smoking because they think there’s a safe way to experiment with cigarettes, the Campaign for Tobacco-Free Kids and several health associations wrote in a letter urging the FDA to reverse its 22nd Century .

22nd Century’s cigarettes are still dangerous, and consumers must substantially cut back or quit smoking to get health advantages. But anti-smoking groups fear many smokers won’t understand that.

“If people are looking at this as a magic bullet and are still continuing their tobacco use, they are not doing anything to change their risk,” said Sward, of the lung association.

Anti-smoking groups particularly object to allowing 22nd Century to market menthol cigarettes even as the FDA is considering outlawing such cigarettes nationwide.

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FDA spokesperson Abby Capobianco confirmed that 22nd Century has the only FDA-authorized low-nicotine cigarette but did not respond to requests for comment on the FDA’s plans for regulating nicotine in cigarettes.

California already outlaws menthol flavoring, and Miller said the company won’t that state’s ban and won’t sell its menthol cigarettes in California.

But Miller hopes the company will eventually win an exemption from any federal ban, in part, he said, because more than half of menthol smokers are likely to switch to conventional cigarettes.

“That’s not what the FDA wants to happen,” Miller said. “They need an offramp for these menthol smokers and ours is obviously the natural.”

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The company is expanding into California, Florida, and Texas because of the nation-leading size of their smoking populations. It previously announced plans to also begin selling its very low-nicotine, or VLN, cigarettes this year in Arizona, New Mexico, and Utah, and it may move into 10 more states.

The company is prioritizing seven states that offer tax incentives for products the FDA has said reduce tobacco risk, believing its cigarettes will have a price advantage over others in Colorado, Connecticut, Kentucky, Michigan, North Carolina, New Mexico, and Utah. Miller said the company may lobby California lawmakers to add similar incentives as part of the state’s extensive efforts to discourage smoking, which still addicts 10% of its residents.

Miller declined to disclose the company’s market share from the two test states but said sales were above expectations.

“If we can get this to the level of, like, a nonalcoholic beer — you know, 3% to 5% of the category — it’s a game changer,” Miller said. “We know that there’s a latent demand in the market for this product.”

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

By: Don Thompson
Title: As Low-Nicotine Cigarettes Hit the Market, Anti-Smoking Groups Press for Wider Standard
Sourced From: kffhealthnews.org//article/low-nicotine-cigarettes-fda-standard-addictive/
Published Date: Fri, 30 Jun 2023 09:00:00 +0000

Kaiser Health News

Harris’ California Health Care Battles Signal Fights Ahead for Hospitals if She Wins

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Bernard J. Wolfson and Phil Galewitz, KFF Health
Mon, 05 Aug 2024 09:00:00 +0000

When Kamala Harris was California’s top prosecutor, she was concerned that mergers among hospitals, physician groups, and health insurers could thwart competition and lead to higher prices for patients. If she wins the presidency in November, she’ll have a wide range of options to blunt monopolistic behavior nationwide.

The Democratic vice president could influence the Federal Trade Commission and instruct the departments of Justice and Health and Human Services to prioritize enforcement of antitrust laws and channel resources accordingly. Already, the Biden administration has taken an aggressive stance against mergers and acquisitions. In his first year in office, issued an executive order intended to intensify antitrust enforcement across multiple industries, including health care.

Under Biden, the FTC and DOJ have fought more mergers than they have in decades, often targeting health care deals.

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“What Harris could do is set the tone that she is going to continue this laser focus on competition and health care prices,” said Katie Gudiksen, a senior health policy researcher at University of California College of the Law, San Francisco.

The Harris campaign didn’t respond to a request for comment.

For decades, the health industry has undergone consolidation despite efforts to maintain competition. When health expand, adding hospitals and doctor practices to their portfolios, they often gain a large enough share of regional health care resources to command higher prices from insurers. That results in higher premiums and other health care costs for consumers and employers, according to numerous studies.

Health insurers have also consolidated in recent decades, leaving only a handful controlling most markets.

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Health care analysts say it’s possible for Harris to slow the momentum of consolidation by blocking future mergers that could lead to higher prices and lower-quality care. But many of them agree the consolidation that has already taken place is an inescapable feature of the U.S. health care landscape.

“It’s hard to unscramble the eggs,” said Bob Town, an economics professor at the University of Texas.

There were nearly 1,600 hospital mergers in the U.S. from 1998 to 2017 and 428 hospital and health system mergers from 2018 to 2023, according to a KFF study. The percentage of community hospitals that belong to a larger health system rose from 53 in 2005 to 68 in 2022. And in another sign of market concentration, as of January, well over three-quarters of the nation’s physicians were employed by hospitals or corporations, according to a report produced by Avalere Health.

Despite former President Donald Trump’s hostility to regulation as a candidate, his administration was active on antitrust efforts — though it did allow one of the largest health care mergers in U.S. history, between drugstore chain CVS Health and the insurer Aetna. Overall, Trump’s Justice Department was more aggressive on mergers than past Republican administrations.

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Harris, as California’s from 2011 to 2017, jump-started health care investigations and enforcement.

“She pushed back against anticompetitive pricing,” said Rob Bonta, California’s current attorney general, who is a Democrat.

One of Harris’ most impactful decisions was a 2012 investigation into whether consolidation among hospitals and physician practices gave health systems the clout to demand higher prices. That probe bore fruit six years later after Harris’ successor, Xavier Becerra, filed a landmark lawsuit against Sutter Health, the giant Northern California hospital operator, for anticompetitive behavior. Sutter settled with the state for $575 million.

In 2014, Harris was among 16 state attorneys general who joined the FTC in a lawsuit to dismantle a merger between one of Idaho’s largest hospital chains and its biggest physician group. In 2016, Harris joined the U.S. Department of Justice and 11 other states in a successful lawsuit to block a proposed $48.3 merger between two of the nation’s largest health insurers, Cigna and Anthem.

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Attempts to give the attorney general the power to nix or impose conditions on a wide range of health care mergers have been fiercely, and successfully, opposed by California’s hospital industry. Most recently, the hospital industry persuaded state lawmakers to exempt for-profit hospitals from pending legislation that would subject private equity-backed health care transactions to review by the attorney general.

A spokesperson for the California Hospital Association declined to comment.

As attorney general of California, Harris’ work was eased by the state’s deep blue political hue. Were she to be elected president, she could face a less hospitable political environment, especially if Republicans control one or both houses of Congress. In addition, she could face opposition from powerful health care lobbyists.

Though it often gets a bad rap, consolidation in health care also confers benefits. Many choose to join large organizations because it relieves them of the administrative headaches and financial burdens of running their own practices. And being absorbed into a large health system can be a lifeline for financially troubled hospitals.

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Still, a major reason health systems choose to expand through acquisition is to accumulate market clout so they can match consolidation among insurers and bargain with them for higher payments. It’s an understandable reaction to the financial pressures hospitals are under, said James Robinson, a professor of health economics at the University of California-Berkeley.

Robinson noted that hospitals are required to treat anyone who shows up at the emergency room, including uninsured people. Many hospitals have a large number of patients on Medicaid, which pays poorly. And in California, they face a series of regulatory requirements, including seismic retrofitting and nurse staffing minimums, that are expensive. “How are they going to pay for that?” Robinson said.

At the federal level, any effort to blunt anticompetitive mergers would depend in part on how aggressive the FTC is in pursuing the most egregious cases. FTC Chair Lina Khan has made the FTC more proactive in this regard.

Last year, the FTC and DOJ jointly issued new merger guidelines, which suggested the federal government would scrutinize deals more closely and take a broader view of which ones violate antitrust laws. In September, the FTC filed a lawsuit against an anesthesiology group and its private equity backer, alleging they had engaged in anticompetitive practices in Texas to up prices.

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In January, the agency sued to stop a $320 million hospital acquisition in North Carolina.

Still, many transactions don’t come to the attention of the FTC because their value is below its $119.5 million reporting threshold. And even if it heard about more deals, “it is very underresourced and needing to be very selective in which mergers they ,” said Paul Ginsburg, a professor of the practice of health policy at the University of Southern California’s Sol Price School of Public Policy.

Khan’s term ends in September 2024, and Harris, if elected, could try to reappoint her, though her ability to do so may depend on which party controls the Senate.

Harris could also promote regulations that discourage monopolistic behaviors such as all-or-nothing contracting, in which large health systems refuse to do business with insurance companies unless they agree to include all their facilities in their networks, whether needed or not. That behavior was one of the core allegations in the Sutter case.

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She could also seek policies at the Department of Health and Human Services, which runs Medicare and Medicaid, that encourage competition.

Bonta, California’s current attorney general, said that, while there are bad mergers, there are also good ones. “We approve them all the time,” he said. “And we approve them with conditions that address cost and that address access and that address quality.”

He expects Harris to bring similar concerns to the presidency if she wins.

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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By: Bernard J. Wolfson and Phil Galewitz, KFF Health News
Title: Harris’ California Health Care Battles Signal Fights Ahead for Hospitals if She Wins
Sourced From: kffhealthnews.org/news/article/kamala-harris-california-hospitals-health-care-antitrust-ftc/
Published Date: Mon, 05 Aug 2024 09:00:00 +0000

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Kaiser Health News

Urgent Care or ER? With ‘One-Stop Shop,’ Hospitals Offer Both Under Same Roof

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Phil Galewitz, KFF Health News
Fri, 02 Aug 2024 09:00:00 +0000

JACKSONVILLE, . — Facing an ultracompetitive market in one of the nation’s fastest-growing , UF Health is trying a new way to attract : a combination emergency room and urgent care center.

In the past year and a half, UF Health and a private equity-backed company, Intuitive Health, have opened three centers that offer both types of care 24/7 so patients don’t have to decide which facility they need.

Instead, there decide whether it’s urgent or emergency care —the health system bills accordingly — and inform the patient of their decision at the time of the service.

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“Most of the time you do not realize where you should go — to an urgent care or an ER — and that triage decision you make can have dramatic economic repercussions,” said Steven Wylie, associate vice president for planning and business at UF Health Jacksonville. About 70% of patients at its facilities are billed at urgent care rates, Wylie said.

Emergency care is almost always more expensive than urgent care. For patients who might otherwise show up at the ER with an urgent care-level problem — a small cut that requires stitches or an infection treatable with antibiotics — the savings could be hundreds or thousands of dollars.

While no research has been conducted on this new hybrid model, consumer advocates worry hospitals are more likely to route patients to costlier ER-level care whenever possible.

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For instance, some services that trigger higher-priced, ER-level care at UF Health’s facilities — such as blood work and ultrasounds — can be obtained at some urgent care centers.

“That sounds crazy, that a blood test can trigger an ER fee, which can cost thousands of dollars,” said Cynthia Fisher, founder and chair of PatientRightsAdvocate.org, a patient advocacy organization.

For UF Health, the hybrid centers can increase profits because they help attract patients. Those patient visits can lead to more revenue through diagnostic testing and referrals for specialists or inpatient care.

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Offering less expensive urgent care around-the-clock, the hybrid facilities stand out in an industry known for its aggressive billing practices.

On a recent visit to one of UF Health’s facilities about 15 miles southeast of downtown, several patients said in interviews that they sought a short wait for care. None had sat in the waiting room more than five minutes.

“Sometimes urgent care sends you to the ER, so here you can get everything,” said Andrea Cruz, 24, who was pregnant and came in for shortness of breath. Cruz said she was being treated as an ER patient because she needed blood tests and monitoring.

“It’s good to have a place like this that can treat you no matter what,” said Penny Wilding, 91, who said she has no regular physician and was being evaluated for a likely urinary tract infection.

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UF Health is one of about a dozen health in 10 states partnering with Intuitive Health to set up and hybrid ER-urgent care facilities. More are in the works; VHC Health, a large hospital in Arlington, Virginia, plans to start building one this year.

Intuitive Health was established in 2008 by three emergency physicians. For several years the company ran independent combination ER-urgent care centers in Texas.

Then Altamont Capital Partners, a multibillion-dollar private equity firm based in Palo Alto, California, bought a majority stake in Intuitive in 2014.

Soon after, the company began partnering with hospitals to open facilities in states including Arizona, Indiana, Kentucky, and Delaware. Under their agreements, the hospitals handle medical staff and billing while Intuitive manages administrative functions — including initial efforts to collect payment, including checking insurance and taking copays — and nonclinical staff, said Thom Herrmann, CEO of Intuitive Health.

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Herrmann said hospitals have become more interested in the concept as Medicare and other insurers pay for value instead of just a fee for each service. That means hospitals have an incentive to find ways to treat patients for less.

And Intuitive has a strong incentive to partner with hospitals, said Christine Monahan, an assistant research professor at the Center on Health Insurance Reforms at Georgetown University: Facilities licensed as freestanding emergency rooms — as Intuitive’s are — must be affiliated with hospitals to be covered by Medicare.

At the combo facilities, emergency room specialists determine whether to bill for higher-priced ER or lower-priced urgent care after patients undergo a medical screening. They compare the care needed against a list of criteria that trigger emergency-level care and bills, such as the patient requiring IV fluids or cardiac monitoring.

Inside its combo facilities, UF posts a sign listing some of the urgent care services it offers, including treatment for ear infections, sprains, and minor wounds. When its doctors determine ER-level care is necessary, UF requires patients to sign a form acknowledging they will be billed for an ER visit.

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Patients who opt out of ER care at that time are charged a triage fee. UF would not disclose the amount of the fee, saying it varies.

UF officials say patients pay only for the level of care they need. Its centers accept most insurance plans, including Medicare, which covers people older than 65 and those with disabilities, and Medicaid, the program for low-income people.

But there are important caveats, said Fisher, the patient advocate.

Patients who pay cash for urgent care at UF’s hybrid centers are charged an “all-inclusive” $250 fee, whether they need an X-ray or a rapid strep test, to name two such services, or both.

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But if they use insurance, patients may have higher cost sharing if their health plan is charged more than it would pay for stand-alone urgent care, she said.

Also, federal surprise billing protections that shield patients in an ER don’t extend to urgent care centers, Fisher said.

Herrmann said Intuitive’s facilities charge commercial insurers for urgent care the same as if they provided only urgent care. But Medicare may pay more.

While urgent care has long been intended for minor injuries and illnesses and ERs are supposed to be for – or health-threatening conditions, the two models have melded in recent years. Urgent care clinics have increased the scope of injuries and conditions they can treat, while hospitals have taken to advertising ER wait times on highway billboards to attract patients.

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Intuitive is credited with pioneering hybrid ER-urgent care, though its facilities are not the only ones with both “emergency” and “urgent care” on their signs. Such branding can sometimes confuse patients.

While Intuitive’s hybrid facilities offer some price transparency, providers have the upper hand on cost, said Vivian Ho, a health economist at Rice University in Texas. “Patients are at the mercy of what the hospital tells them,” she said.

But Daniel Marthey, an assistant professor of health policy and management at Texas A&M University, said the facilities can help patients find a lower-cost option for care by avoiding steep ER bills when they need only urgent-level care. “This is a potentially good thing for patients,” he said.

Marthey said hospitals may be investing in hybrid facilities to make up for lost revenue after federal surprise medical billing protections took effect in 2022 and restricted what hospitals could charge patients treated by out-of-network providers, particularly in emergencies.

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“Basically, they are just competing for market share,” Marthey said.

UF Health has placed its new facilities in suburban near freestanding ERs owned by competitors HCA and Ascension rather than near its downtown hospital in Jacksonville. It is also building a fourth facility, near The Villages, a large retirement community more than 100 miles south.

“This has been more of an offensive move to expand our market reach and go into suburban markets,” Wylie said.

Though the three centers are not state-approved to care for trauma patients, doctors there said they can handle almost any emergency, including heart attacks and strokes. Patients needing hospitalization are taken by ambulance to the UF hospital about 20 minutes away. If they need to follow up with a specialist, they’re referred to a UF physician.

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“If you fall and sprain your leg and need an X-ray and crutches, you can come here and get charged urgent care,” said Justin Nippert, medical director of two of UF’s combo centers. “But if you break your ankle and need it put back in place it can get treated here, too. It’s a one-stop shop.”

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By: Phil Galewitz, KFF Health News
Title: Urgent Care or ER? With ‘One-Stop Shop,’ Hospitals Offer Both Under Same Roof
Sourced From: kffhealthnews.org/news/article/urgent-emergency-care-combo-centers-intuitive-health-jacksonville-florida/
Published Date: Fri, 02 Aug 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/since-fall-of-roe-self-managed-abortions-have-increased/

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Since Fall of ‘Roe,’ Self-Managed Abortions Have Increased

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Sarah Varney, KFF Health News
Fri, 02 Aug 2024 09:00:00 +0000

The percentage of people who say they’ve tried to end a pregnancy without medical assistance increased after the Supreme Court overturned . That’s according to a study published Tuesday in the online journal JAMA Network Open.

Tia Freeman, a reproductive health organizer, leads workshops for Tennesseans on how to safely take medication abortion pills outside of medical settings.

Abortion is almost entirely illegal in Tennessee. Freeman, who lives near Nashville, said people planning to stop pregnancies have all sorts of reasons for wanting to do so without help from the formal health care system — including the cost of traveling to another , of finding child care, and fear of lost wages.

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“Some people, it’s that they don’t have the networks in their families where they would need to have someone them to a clinic and then sit with them,” said Freeman, who works for Self-Managed Abortion; Safe and Supported, a U.S.-based project of Women Help Women, an international nonprofit that advocates for abortion access.

“Maybe their family is superconservative and they would rather get the pills in their home and do it by themselves,” she said.

The new study is from Advancing New Standards in Reproductive Health, a research group based at the of California-San Francisco. The researchers surveyed more than 7,000 people ages 15 to 49 from December 2021 to January 2022 and another 7,000-plus from June 2023 to July 2023.

Of the respondents who had attempted self-managed abortions, they found the percentage who used the abortion pill mifepristone was 11 in 2023 — up from 6.6 before the Supreme Court ended federal abortion rights in 2022.

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One of the most common reasons for seeking a self-administered abortion was privacy concerns, said a study co-author, epidemiologist Lauren Ralph.

“So not wanting others to know that they were seeking or in need of an abortion or wanted to maintain autonomy in the ,” Ralph said. “They liked it was something under their control that they could do on their own.”

Kristi Hamrick, vice president of media and policy at Students for Action, a national anti-abortion group, said she doesn’t believe the study findings, which she said benefit people who abortion pills.

“It should surprise no one that the abortion lobby reports their business is doing well, without problems,” Hamrick said in an emailed statement.

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Ralph said in addition to privacy concerns, state laws criminalizing abortion also weighed heavily on women’s minds.

“We found 6% of people said the reason they self-managed was because abortion was illegal where they lived,” Ralph said.

In the JAMA study, women who self-managed abortion attempts reported using a range of methods, including using or alcohol, lifting heavy objects, and taking a hot bath. In addition, about 22% reported hitting themselves in the stomach. Nearly 4% reported inserting an object in their body.

The term “self-managed abortion” may conjure images of back-alley procedures from the 1950s and ’60s. But OB-GYN Laura Laursen, a family planning physician in Chicago, said self-managed abortions using medication abortion — the drugs mifepristone and misoprostol — are far safer, whether done inside or outside the health care system.

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“They’re equally safe no matter which way you do it,” Laursen said. “It involves passing a pregnancy and bleeding, which is what happens when you have a miscarriage. If your body doesn’t have a miscarriage on its own, these are actually the medications we give women to pass the miscarriage.”

Since Roe‘s end, more than 20 states have banned or further restricted abortion.

——————————
By: Sarah Varney, KFF Health News
Title: Since Fall of ‘Roe,’ Self-Managed Abortions Have Increased
Sourced From: kffhealthnews.org/news/article/self-managed-abortions-increase-post-roe-dobbs-privacy-concerns/
Published Date: Fri, 02 Aug 2024 09:00:00 +0000

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