“We didn’t even know germs caused disease back then,” said Kristin Lyerly, an obstetrician-gynecologist who lives in Green Bay.

Like undertakers and garbage haulers, obstetricians see the nitty-gritty of human existence that can be ghastly and grotesque. A fetus with organs growing outside its body. A woman forced to birth a baby with no skull to push open her cervix.

OB-GYN Anna Igler regularly performed abortions for medically indicated reasons before the Supreme Court overturned the right to abortion last year. She is beyond fed up.

“I’m at a different level with it now,” she said. “Part of me is so upset at people for sticking their head in the sand.” With her world inside a Green Bay hospital in turmoil, she said, she cannot fathom that people might be oblivious to the government’s incursion into their medical care. “So many people I’ve talked to have no idea what our laws are in our state.”

Even now, a year later, Igler said, expectant parents come into her office with the assumption that if their fetus has a lethal genetic disorder, like anencephaly or trisomy 13 or 18, they can end the pregnancy safely.

“They are shocked when I tell them they can’t,” Igler said, “and they are shocked when I tell them we are following the law from 1849.”

She was referring to the state’s original abortion law, which was passed before the Civil War, when women could not vote or own property. The law makes it a felony to perform an abortion at any stage of pregnancy, unless it would prevent the death of the pregnant person.

It had been some time since these women were together, and they were eager to compare notes. The certified midwife spoke on the condition of anonymity because she’s not authorized to talk to the media and is concerned about losing her job at a local health system. “My biggest issue right now is getting medication to end a pregnancy that has already passed,” she said. “I’m finding locally that pharmacists just won’t dispense the medication.”

She offered a rundown: One pharmacist told her patient that misoprostol, a drug that causes cramping to expel the pregnancy tissue, had expired. Another, at a Walgreens, simply canceled the order. A third said he needed preauthorization, noting, “It’s a $3 pill, and we’re not going to get preauthorization on a weekend.”

The midwife said she and physician colleagues in her practice have half-joked that they’d send a gift basket to one pharmacist in town she’d found who will fill their prescriptions for abortion pills.

Now, when a patient miscarries, the midwife said, “we warn patients that this might happen, and they are like, ‘But my baby is dead,’ and I tell them, ‘I’m sorry. I don’t know why, but a lot of pharmacists in Green Bay think it’s their job to police this.’”

A year into this new era of compulsory birth for most women with pregnancies, the dismay and disorientation of those first few months have settled into, if not acceptance or resignation, a kind of chronic fear. Obstetricians and gynecologists are fearful of practicing medicine as they were trained.

A recent survey by KFF pollsters of OB-GYNS in states with abortion bans found 40% felt constrained in treating patients for miscarriages or other pregnancy-related medical emergencies since the Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision last summer. Nearly half of them said their ability to practice standard medical care has become worse.

The specter of felony charges and losing a medical license has led to futile exercises.

Under the Wisconsin abortion ban — and bans in at least 13 other states — physicians who cannot detect fetal cardiac activity should, in theory, not face criminal charges for prescribing pills for a medication abortion or performing abortions. But physicians here in Green Bay, and others interviewed in Madison, said they — and the litigation-averse hospitals they work for — are requiring patients whose pregnancies are no longer viable, or who have gestational sacs that do not contain an embryo, to return for multiple ultrasounds, forcing them to carry nonviable pregnancies for weeks.

Before Wisconsin’s abortion ban, Igler would typically use the ultrasound machine in her office to detect when a patient’s pregnancy had ceased. She would break the news to expectant parents there. In some cases, a patient wanted further ultrasounds and she would refer them to the fetal-imaging department. It might help with their grieving, and “I was happy to do that for them,” Igler said.

But her bedside ultrasound can’t record and save the images that Igler would now need to prove that her medical judgment was reasonable during a criminal prosecution, so she is compelled to send all her patients for additional imaging.

“It seems cruel to show a woman her nonviable, dead baby and then say, ‘Well, now I have to bring you over to fetal imaging so we can record a picture and you have to see it again,’” she said.

In March, Rep. Ron Tusler, a Republican who represents a rural swath of Wisconsin south of Green Bay, posted on Facebook, “Thank God for the Dobbs decision!” In response, a local resident asked, “If my non-verbal, non-ambulatory 14-year-old daughter is assaulted, should she be forced to carry?”

The exchange escalated into a confrontation. “Is her health jeopardized?” Tusler asked. “Is she unable to leave the state? Can she provide consent?”

In the torrent of vitriol, certain moments stand out. Igler was incensed at the callous response and jumped in, writing: “Are you a monster, Ron Tusler? Do you know what compassion is? Come the next election, you will feel the backlash of your inhumane and outdated views. Get your hands off women’s bodies and out of the exam room. I’m an obstetrician. I’m the expert, not you.”

Tusler shot back that Igler was “angry she can’t kill babies until and occasionally after birth” and asked whether “I’m a monster for stopping her.” He wrote, “Honestly, how many babies have you aborted? How much money have you made from it? Did your hospital harvest the bodies for stem cells?”

The lunchtime rush at the restaurant in Green Bay had eased, and the women stared at the Facebook post on Igler’s phone.

She shook her head in baffled amusement. “This doesn’t even make sense,” she said. “It’s a conspiracy theory. I make so much more money if people actually have their babies. And if I don’t give out birth control, I would make a lot more money.”

Those sitting at the table laughed at the absurdity.

The salad bowls were empty. Everyone had told their own abortion stories. Igler was forced to travel to Colorado after her baby, at 25 weeks, was ravaged by a viral infection; Lyerly had lost a pregnancy at 17 weeks and did not want to endure the trauma of a vaginal birth.

Some 22 million women living today have had an abortion. It doesn’t take much effort to find a few of them.

Igler has found a community of women to grieve with, in a Facebook group called “Ending a Wanted Pregnancy.” There are an untold number of other online groups.

“Politicians would like to believe we live in a perfect world where these things don’t happen,” she said.

The Wisconsin Legislature is one of the most gerrymandered in the country, according to Princeton University’s Gerrymandering Project. Republicans hold a majority in the state Senate and Assembly, and last month Senate Republicans voted unanimously to keep the 1849 abortion ban.

But a judicial alternative to restoring abortion rights has begun to unfold. In April, Janet Protasiewicz, an abortion rights supporter promoted by Democrats, won a seat on the Wisconsin Supreme Court, giving liberal justices a narrow majority and opening a path for a ruling on the legitimacy of the 1849 law. On July 7, a Circuit Court judge in Dane County, Diane Schlipper, appeared to doubt the validity of the pre-Civil War-era ban, allowing a lawsuit by Attorney General Josh Kaul, a Democrat, to proceed.

For now, Lyerly is driving across the border to work in rural Minnesota. “I want to practice medicine here,” she said, “but first we have to get rid of this law.”

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After her weight began climbing in high school, she spent years losing 50 or 100 pounds then gaining it back. Morris, 78, was at her heaviest in her mid-40s, standing 5 feet 10½ inches and weighing 310 pounds. The Pittsburgh resident has had diabetes for more than 40 years.

Managing her weight was a losing battle until Morris’ doctor prescribed a Type 2 diabetes medication, Ozempic, four months ago. It’s one in a new category of medications changing how ordinary people as well as medical experts think about obesity, a condition that affects nearly 4 in 10 people 60 and older.

The drugs include Ozempic’s sister medication, Wegovy, a weight loss drug with identical ingredients, which the FDA approved in 2021, and Mounjaro, approved as a diabetes treatment in 2022. (Ozempic was approved for diabetes in 2017.) Several other drugs are in development.

The medications reduce feelings of hunger, generate a sensation of fullness, and have been shown to help people lose an average of 15% or more of their weight.

“It takes your appetite right away. I wasn’t hungry at all and I lost weight like mad,” said Morris, who has shed 40 pounds.

But how these medications will affect older adults in the long run isn’t well understood. (Patients need to remain on the drugs permanently or risk regaining the weight they’ve lost.)

Will they help prevent cardiovascular disease and other chronic illnesses in obese older adults? Will they reduce rates of disability and improve people’s ability to move and manage daily tasks? Will they enhance people’s lives and alleviate symptoms associated with obesity-related chronic illnesses?

Unfortunately, clinical trials of the medications haven’t included significant numbers of people ages 65 and older, leaving gaps in the available data.

While the drugs appear to be safe — the most common side effects are nausea, diarrhea, vomiting, constipation, and stomach pain — “they’ve only been on the market for a few years and caution is still needed,” said Mitchell Lazar, founding director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania Perelman School of Medicine.

Given these uncertainties, how are experts approaching the use of the new obesity medications in older people? As might be expected, opinions and practices vary. But several themes emerged in nearly two dozen interviews.

The first was frustration with limited access to the drugs. Because Medicare doesn’t cover weight loss medications and they can cost more than $10,000 a year, seniors’ ability to get the new drugs is restricted.

There is an exception: Medicare will cover Ozempic and Mounjaro if an older adult has diabetes, because the insurance program pays for diabetes therapies.

“We need Medicare to cover these drugs,” said Shauna Matilda Assadzandi, a geriatrician at the University of Pittsburgh who cares for Morris. Recently, she said, she tried to persuade a Medicare Advantage plan representative to authorize Wegovy for a patient with high blood pressure and cholesterol who was gaining weight rapidly.

“I’m just waiting for this patient’s blood sugar to rise to a level where diabetes can be diagnosed. Wouldn’t it make sense to intervene now?” she remembered saying. The representative’s answer: “No. We have to follow the rules.”

Seeking to change that, a bipartisan group of lawmakers has reintroduced the Treat and Reduce Obesity Act, which would require Medicare to cover weight loss drugs. But the proposal, which had been considered previously, has languished amid concerns over enormous potential costs for Medicare.

If all beneficiaries with an obesity diagnosis took brand-name semaglutide drugs (the new class of medications), annual costs would top $13.5 billion, according to a recent analysis in The New England Journal of Medicine. If all older obese adults on Medicare — a significantly larger population — took them, the cost would exceed the total spent on Medicare’s Part D drug program, which was $145 billion in 2019.

Laurie Rich, 63, of Canton, Massachusetts, was caught off guard by Medicare’s policies, which have applied to her since she qualified for Social Security Disability Insurance in December. Before that, Rich took Wegovy and another weight loss medication — both covered by private insurance — and she’d lost nearly 42 pounds. Now, Rich can’t get Wegovy and she’s regained 14 pounds.

“I haven’t changed my eating. The only thing that’s different is that some signal in my brain is telling me I’m hungry all the time,” Rich told me. “I feel horrible.” She knows that if she gains more weight, her care will cost much more.

While acknowledging difficult policy decisions that lie ahead, experts voiced considerable agreement on which older adults should take these drugs.

Generally, the medications are recommended for people with a body mass index over 30 (the World Health Organization’s definition of obesity) and those with a BMI of 27 or above and at least one obesity-related condition, such as diabetes, high blood pressure, or high cholesterol. There are no guidelines for their use in people 65 and older. (BMI is calculated based on a person’s weight and height.)

But those recommendations are problematic because BMI can under- or overestimate older adults’ body fat, the most problematic feature of obesity, noted Rodolfo Galindo, director of the Comprehensive Diabetes Center at the University of Miami Health System.

Dennis Kerrigan, director of weight management at Henry Ford Health in Michigan, a system with five hospitals, suggests physicians also examine waist circumference in older patients because abdominal fat puts them at higher risk than fat carried in the hips or buttocks. (For men, a waist over 40 inches is of concern; for women, 35 is the threshold.)

Fatima Stanford, an obesity medicine scientist at Massachusetts General Hospital, said the new drugs are “best suited for older patients who have clinical evidence of obesity,” such as elevated cholesterol or blood sugar, and people with serious obesity-related conditions such as osteoarthritis or heart disease.

Since going on Mounjaro three months ago, Muriel Branch, 73, of Perryville, Arkansas, has lost 40 pounds and stopped taking three medications as her health has improved. “I feel real good about myself,” she told me.

When adults with obesity lose weight, their risk of dying is reduced by up to 15%, according to Dinesh Edem, Branch’s doctor and the director of the medical weight management program at the University of Arkansas for Medical Sciences.

Still, weight loss alone should not be recommended to older adults, because it entails the loss of muscle mass as well as fat, experts agree. And with aging, the shrinkage of muscle mass that starts earlier in life accelerates, contributing to falls, weakness, the loss of functioning, and the onset of frailty.

Between ages 60 and 70, about 12% of muscle mass falls away, researchers estimate; after 80, it reaches 30%.

To preserve muscle mass, seniors losing weight should be prescribed physical activity — both aerobic exercise and strength training, experts agree.

Also, as older adults taking weight loss drugs eat less, “it’s critically important that their diet includes adequate protein and calcium to preserve bone and muscle mass,” said Anne Newman, director of the Center for Aging and Population Health at the University of Pittsburgh.

Ongoing monitoring of older adults having gastrointestinal side effects is needed to ensure they’re getting enough food and water, said Jamy Ard, co-director of Wake Forest Baptist Health’s Weight Management Center.

Generally, the goal for older adults should be to lose 1 to 2 pounds a week, with attention to diet and exercise accompanying medication management.

“My concern is, once we put patients on these obesity drugs, are we supporting lifestyle changes that will maintain their health? Medication alone won’t be sufficient; we will still need to address behaviors,” said Sukhpreet Singh, system medical director at Henry Ford’s weight management program.

We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care, and advice you need in dealing with the health care system. Visit kffhealthnews.org/columnists to submit your requests or tips.

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Aimee Quicke has made repeated trips to emergency rooms, hospitals, behavioral health facilities, and psychiatric lockdowns for mental health crises — including suicidal thoughts — since she was 11.

The 40-year-old resident of Le Mars, Iowa, has bipolar and obsessive-compulsive disorders. “Some of the visits were helpful and some were not,” she said. “It was like coming in and going out and just nothing different was happening.”

Then she heard about Rhonda’s House, a rural peer respite program that opened on the other side of the state in 2018, through acquaintances in her community.

That facility, and dozens of others like it established nationwide over the past 20 years, offers a short-term, homelike, nurturing environment for people who are experiencing a mental health crisis but don’t need immediate medical attention. At respites, patients are treated like guests, proponents say, and can feel heard and keep their dignity without having to relinquish their clothes and other belongings.

During her weeklong stay at Rhonda’s House, which founder and executive director Todd Noack referred to as “a bed-and-breakfast facility for emotional distress,” Quicke made many breakthroughs, working on her self-esteem and gaining better coping skills. If she hadn’t found the program, she said, “I don’t think I would have come out of 2020.”

Public health professionals say respite facilities can potentially play a big role in addressing a national mental health crisis that accelerated dramatically during the covid-19 pandemic, especially when it comes to suicide prevention.

“It’s a really important piece of the larger puzzle of how to improve health care and reduce suicide risk, because there is a ‘traffic jam’ in suicide prevention,” said Jane Pearson, chair of the National Institute of Mental Health Suicide Research Consortium.

Respites rely on trained peers to provide care, and often serve patients who might otherwise visit overburdened ERs, psychiatric institutions, and therapists. Today there are 42 community-based respite programs spread across 14 states, including new ones opened recently in Tacoma, Washington, and Grand Rapids, Michigan. Most are nonprofits governed by a patchwork of state guidelines, and they’re funded by a mixture of local, state, and federal grants.

Experts say the programs fill a void, though there is little hard data on their effectiveness. Paolo del Vecchio, director of the Office of Recovery at the federal Substance Abuse and Mental Health Services Administration, said peer-run respites have proven themselves as an “evidence-based model of care,” with positive effects including reduced hospitalizations and increased engagement with community support services.

A 2015 study published online in the journal Psychiatric Services found that people who sought respite were 70% less likely to use inpatient emergency services than non-respite users.

Still, del Vecchio said, more research is needed to analyze how the programs are working and troubleshoot problems. SAMHSA is conducting a cost-benefit analysis of respite programs that officials hope to release this summer.

Pearson said she would like to see more research on who uses respites, how they are advertised, clients’ reasons for seeking them, and whether they deliver what they promise.

Respites can be especially important in rural America, where suicides increased 46% from 2000 to 2020, compared with 27.3% in urban areas, according to the Centers for Disease Control and Prevention. Rural residents also have 1½ times the rates of ER visits for self-harm as urban residents.

Del Vecchio hopes greater awareness can help bring the promising respite approach to the states with the highest suicide rates, including Wyoming, Montana, Alaska, and New Mexico.

Rhonda’s House, in Dewitt, Iowa, has provided care to 392 people over the past five years, and recently moved into a three-story, five-bedroom house with two baths. Peer specialists in Iowa must complete 40 hours of training plus six hours of ethics counseling, and then work 500 hours to become eligible to take a state certification test.

For Quicke, Rhonda’s House was a lifesaver during a brutal 2020. The pandemic had isolated her from her support system, her brother-in-law died, her long-term partner moved out, and her mother had open-heart surgery.

“There was a lot of chaos. A lot of family fights broke out. That’s when I took off — packed a bag and left for respite,” said Quicke. “There was nowhere else closer to go.”

She drove six hours from her home to Rhonda’s House, where she found 24-hour help that you “just can’t get from an emergency room or hospital.”

Unlike traditional hospital staffers, peers are available to speak with guests whenever they are needed, which Quicke appreciated since she has “a lot of panic and anxiety in the night and it’s frightful.” She also found it easy and comforting to speak with peers with “lived experience,” or firsthand experience with mental health challenges.

Allowing people to reach out for help without being judged is a crucial feature of the respite model, said Paul Pfeiffer, a psychiatrist at the University of Michigan’s medical center. He cautioned against regulations that would make them more like hospitals, noting that many people in trouble avoid getting help because they fear being locked up in a psychiatric facility.

Quicke said she learned a lot during her stay at Rhonda’s House. “I always thought I was co-dependent. I learned I just need me and my dogs. I learned wellness tools and that I can be strong and resourceful and resilient,” she said. She described being more conscious of her triggers and said she had “more routines to help with sleep hygiene.”

When Quicke left, respite staffers connected her with community resources close to her home, near the Nebraska border. They also encouraged her to call if she needed help again and told her she could return for another stay after 60 days — giving her time to work through her challenges and freeing up space for others in the meantime.

“Peer respite works 8 out of 10 times,” said Noack, the executive director. “Some people do have to leave to get another level of care, but nothing is ever perfect.”

The average cost of staying at Rhonda’s House is $428 a day — far less than the thousands of dollars a hospital stay typically costs. Noack’s respite does not bill insurance but covers the cost with state and regional contracts, as well as donations, like many other respites.

Some respites receive Medicaid funding. As this type of care grows, more states will explore Medicaid and other funding sources, said del Vecchio.

A few weeks ago Quicke became discouraged after a job rejection. She thought about going back to Rhonda’s House but said she channeled what she learned there during her stay.

“I was able to use my coping skills to get through it,” she said.

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In 14 states, these councils have the ultimate say on the money, which comes from companies that made, distributed, or sold opioid painkillers, including Purdue Pharma, Johnson & Johnson, and Walmart. In 24 other states, plus Washington, D.C., the councils establish budget priorities and make recommendations. Those will affect whether opioid settlement funds go, for example, to improve addiction treatment programs and recovery houses or for more narcotics detectives and prisons.

KFF Health News, along with Johns Hopkins University and Shatterproof, a national nonprofit focused on the addiction crisis, gathered and analyzed data on council members in all states to create the first database of its kind.

The data shows that councils are as unique as states are from one another. They vary in size, power, and the amount of funds they oversee. Members run the gamut from doctors, researchers, and county health directors to law enforcement officers, town managers, and business owners, as well as people in recovery and parents who’ve lost children to addiction.

“The overdose crisis is incredibly complex, and it demands more than just money,” said Rollie Martinson, a policy associate with the nonprofit Community Education Group, which is tracking settlement spending across Appalachia. “We also need the right people in charge of that money.”

That’s the $50 billion question: Are the right people steering the decisions? Already, criticism of the councils has been rife, with stakeholders pointing out shortcomings, from overrepresentation to underrepresentation and many issues in between. For example:

• Council membership doesn’t always align with the states’ hardest-hit populations — by race or geography.
• Heavy presence of specific professional groups — treatment providers, health care executives, or law enforcement officials, for example — might mean money gets directed to those particular interests at the expense of others.
• Few seats are reserved for people who’ve dealt with a substance use disorder themselves or supported a family member with one.

Admittedly, no one can design a perfect council. There’s no agreement on what that would even look like. But when a pile of money this big is at stake, everyone wants in on the action.

More than $3 billion of opioid settlement funds has already landed in government coffers, with installments to come through 2038. The money is meant as restitution for the hundreds of thousands of Americans who have died from drug overdoses in recent decades.

But what restitution looks like depends on whom you ask. People running syringe service programs might suggest spending money immediately on the overdose reversal medication naloxone, while hospital officials might advocate for longer-term investments to increase staffing and treatment beds.

“People naturally want money to go toward their own field or interest,” said Kristen Pendergrass, vice president of state policy at Shatterproof.

And that can trigger hand-wringing.

In many parts of the country, for instance, people who support syringe service programs or similar interventions worry that councils with high numbers of police officers and sheriffs will instead direct large portions of the money to buy squad cars and bulletproof vests. And vice versa.

In most states, though, law enforcement and criminal justice officials make up fewer than one-fifth of council members. In Alaska and Pennsylvania, for instance, they’re not represented at all.

Outliers exist, of course. Tennessee’s 15-member council has two sheriffs, one current and one former district attorney general, a criminal court judge, and a special agent from the state Bureau of Investigation. But like many other councils, it hasn’t awarded funds to specific groups yet, so it’s too soon to tell how the council makeup will influence those decisions.

Pendergrass and Johns Hopkins researcher Sara Whaley, who together compiled the list of council members, say criticism of councils drawing too heavily from one field, geographic area, or race is not just a matter of political correctness, but of practicality.

“Having diverse representation in the room is going to make sure there is a balance on how the funds are spent,” Pendergrass said.

To this end, Courtney Gary-Allen, organizing director for the Maine Recovery Advocacy Project, and her colleagues chose early on to ensure their state’s 15-member council included people who support what’s known as harm reduction, a politically controversial strategy that aims to minimize the risks of using drugs. Ultimately, this push led to the appointment of six candidates, including Gary-Allen, to the panel. Most have personal experience with addiction.

“I feel very strongly that if these six folks weren’t on the council, harm reduction wouldn’t get a single dollar,” she said.

Others are starting to focus on potential lost opportunities.

In New Jersey, Elizabeth Burke Beaty, who is in recovery from substance use disorder, has noticed that most members of her state’s council represent urban enclaves near New York City and Philadelphia. She worries they’ll direct money to their home bases and exclude rural counties, which have the highest rates of overdose deaths and unique barriers to recovery, such as a lack of doctors to treat addiction and transportation to faraway clinics.

Natalie Hamilton, a spokesperson for New Jersey Gov. Phil Murphy, a Democrat who appointed the members, said the council represents “a wide geographic region,” including seven of the state’s 21 counties.

But only two of those represented — Burlington and Hunterdon counties — are considered rural by the state’s Office of Rural Health needs assessment. The state’s hardest-hit rural counties lack a seat at the table.

Now that most of the council seats nationwide are filled, worries about racial equity are growing.

Louisiana, where nearly a third of the population is Black, has no Black council members. In Ohio, where Black residents are dying of overdoses at the highest rates, only one of the 29 council members is Black.

“There’s this perception that this money is not for people who look like me,” said Philip Rutherford, who is chief operating officer of Faces & Voices of Recovery and is Black. His group organizes people in recovery to advocate on addiction issues.

Research shows Black Americans have the fastest-rising overdose death rates and face the most barriers to gold-standard treatments.

In several states, residents have lamented the lack of council members with firsthand knowledge of addiction, who can direct settlement dollars based on personal experiences with the treatment and criminal justice systems. Instead, councils are saturated with treatment providers and health care organizations.

And this, too, raises eyebrows.

“Service providers are going to have a monetary interest,” said Tracie M. Gardner, who leads policy advocacy at the New York-based Legal Action Center. Although most are good people running good treatment programs, they have an inherent conflict with the goal of making people well and stable, she said.

“That is work to put treatment programs out of business,” Gardner said. “We must never forget the business model. It was there for HIV, it was there for covid, and it’s there for the overdose epidemic.”

Councils in South Carolina and New York have already seen some controversy in this vein — when organizations associated with members pursued or were awarded funding. It’s not a particularly surprising occurrence, since the members are chosen for their prominent work in the field.

Both states’ councils have robust conflict-of-interest policies, requiring members to disclose professional and financial connections. New York also has a law precluding council members from using their position for financial gain, and South Carolina uses a rubric to objectively score applications.

That these situations cause alarm regardless shows how much hope and desperation is tied up in this money — and the decisions over who controls it.

“This is the biggest infusion of funding into the addiction treatment field in at least 50 years,” said Gardner. “It’s money coming into a starved system.”

Database Methodology

The list of council members’ names used to build the database was compiled by Johns Hopkins University’s Sara Whaley and Henry Larweh and Shatterproof’s Kristen Pendergrass and Eesha Kulkarni. All council members, even those without voting power, were listed.

Although many states have councils to address the opioid crisis generally, the database focused specifically on councils overseeing the opioid settlement funds. A council’s scope of power was classified as “decision-making” if it directly controls allocations. “Advisory” means the council provides recommendations to another body, which makes final funding decisions.

The data is current as of June 9, 2023.

KFF Health News’ Aneri Pattani, Colleen DeGuzman, and Megan Kalata analyzed the data to determine which categories council members represent, based on the following rules:

— Each council member can be counted in only one category. There is no duplication.

— People should be given the most descriptive categorization possible. For example, attorneys general are “elected officials,” but it is more specific to say they are “law enforcement and criminal justice” officials.

— A “government representative” is typically a government employee who is not elected and does not fit into any other descriptive category — for example, a non-elected county manager.

— People who provide direct services to patients or clients, such as physicians, nurses, therapists, and social workers, are classified as “medical and social service providers.” People with more administrative roles are typically classified as “public” or “private health and human services,” based on their organization’s public or private affiliation.

— “Lived or shared experience” refers to someone who has personally experienced a substance use disorder, has a family member with one, or has lost a loved one to the disease. Because people’s addiction experiences are not always public, only individuals explicitly appointed because of their firsthand connection or to fill a seat reserved for someone with that experience were categorized as such.

KFF Health News’ Colleen DeGuzman and Megan Kalata contributed to this report.

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The Environmental Protection Agency rule would require manufacturers to report many products that contain perfluoroalkyl and polyfluoroalkyl substances. They’re a family of chemicals that don’t degrade in nature and have been linked to cancer, birth defects, and hormone irregularities.

Companies would have to disclose any PFAS that have been manufactured or imported between 2011 and when the rule takes effect, with no exemptions for small businesses or for impurities or byproducts cross-contaminating goods with PFAS. Those disclosures would be available to the public, barring any trade secrets linked to the data. The EPA will finalize the rule in the coming months, agency spokesperson Catherine Milbourn said, then require companies to report back within 12 months.

The effort excludes pesticides, foods and food additives, drugs, cosmetics, and medical devices regulated under the Federal Food, Drug, and Cosmetic Act, Milbourn said. It also is essentially a one-time reporting and record-keeping requirement — and companies wouldn’t need to provide updates.

Still, the chemical and semiconductor industries are grumbling about what the EPA estimated is a potential $1 billion cost to comply with the rule. The U.S. chemical industry says it generates more than $500 billion annually.

On the other side, environmental health activists say the data collection exercise would be flawed, as it accounts for only a tenth of the more than 12,000 PFAS chemicals, which are used in everything from nonstick cookware to kids’ school uniforms. Moreover, they say, it wouldn’t stop PFAS from making their way into the air, waste, or consumer products, nor would it clean up existing contamination.

Congress gave the EPA the power to track PFAS chemicals in 2016, when it revised the Toxic Substances Control Act. Then a bipartisan effort in 2019, which President Donald Trump signed into law, called for the EPA to inventory PFAS. However, health activists warn that unless Congress overhauls U.S. chemical laws to give the EPA and other agencies more power, PFAS will continue to threaten humans and the environment.

These so-called forever chemicals went from marvel to bête noire in just 50 years. When PFAS debuted, they were revered for making Teflon pans nonstick and Gore-Tex jackets waterproof. They are effective at repelling water and oil yet so durable they don’t break down in the natural environment. That strength has become their downfall, as the chemicals accumulate in landfills, soil, drinking water supplies, and, ultimately, human bodies. As scientists learn more about PFAS’ toxic nature, governments around the world have set limits or imposed outright bans.

Because PFAS are found in thousands of products — contact lenses, cosmetics, pharmaceuticals such as Prozac, paper plates, clothing, and dental floss, to name just a few — regulators are scrambling to gather data on the scope of the PFAS threat. The EPA data collection proposal is a move in that direction.

Milbourn told KFF Health News that 1,364 types of PFAS may be covered by the rule, and EPA officials are reviewing public comments they received to determine whether they should modify its scope to capture additional substances.

By contrast, the European Union is discussing banning or limiting 10,000 PFAS chemicals, according to Hanna-Kaisa Torkkeli, a spokesperson for the European Chemicals Agency.

“In the U.S., chemicals are innocent until proven guilty,” said Kyla Bennett, director of science policy at Public Employees for Environmental Responsibility, a nonprofit based outside Washington, D.C. “In the EU and Japan, chemicals are guilty until proven safe — and that’s why they have fewer PFAS.”

That lack of regulation in the U.S. is driving states to take matters into their own hands, pursuing PFAS bans as gridlock and industry lobbying in Washington thwart tougher federal laws. Minnesota’s crackdown on PFAS limits the chemicals in menstrual products, cleaning ingredients, cookware, and dental floss. Maine’s law will ban all avoidable uses of PFAS by 2030. Vermont and California ban PFAS in food packaging.

“The states are acting because our federal system doesn’t currently allow the government to say ‘no more use of PFAS,’” said Liz Hitchcock, director of the federal policy program at Toxic-Free Future, a national advocacy group. “And even if it did, that wouldn’t clean up the mess already made.”

U.S. courts are also weighing in on PFAS contamination. On June 22, 3M agreed to pay up to $12.5 billion to settle lawsuits by communities around the country that argued their drinking water was contaminated by the company’s PFAS-containing products.

Additionally, the U.S. military is moving to limit PFAS, after a report said more than 600,000 troops were exposed to the toxic chemicals in drinking water contaminated largely by PFAS-laden firefighting foam.

Just cleaning up PFAS waste at U.S. military bases could cost at least $10 billion. Removing it from U.S. drinking water supplies could add more than $3.2 billion annually to the bill, according to a report commissioned by the American Water Works Association.

“The CDC estimates that 99% of Americans have PFAS in their blood,” said Melanie Benesh, vice president of government affairs for the Environmental Working Group, a nonprofit that researches the ingredients in household and consumer products. “We estimate that 200 million Americans are exposed to PFAS in their drinking water right now.”

Officials with the U.S. Geological Survey released a similar finding July 5 when they announced that the agency’s researchers estimate more than 45% of U.S. tap water is contaminated with at least one PFAS chemical after they conducted a nationwide study of water samples.

As ubiquitous as PFAS are, the reason they haven’t generated more outrage among the public may be that the damage from PFAS chemicals isn’t immediate. They affect health over time, with repeated exposure.

“People aren’t getting headaches or coughing from exposure to PFAS,” Bennett said. “But they are getting cancer a few years down the line — and they don’t understand why.”

Some environmental health advocates, such as Arthur Bowman III, policy director at the Center for Environmental Health, say the EPA’s data collection project could help. “It will be fairly straightforward for the EPA to gather PFAS information on cleaning products and other wet chemicals that contain PFAS,” Bowman said. “And this will lead to phaseouts of PFAS.”

Some retailers, such as Dick’s Sporting Goods and REI, have recently announced plans to remove the chemicals from many of their products.

But Bowman said it will be more difficult for manufacturers to remove PFAS used in the production of semiconductor chips and printed circuit boards, since alternative products are still in the research phase.

The Semiconductor Industry Association has asked the EPA for an exemption to the proposed reporting requirements because, it maintains, semiconductor manufacturing is so complex that it would be “impossible, even with an unlimited amount of time and resources, to discern the presence (if any) of PFAS in such articles.” Other industries have also asked for waivers.

The American Chemistry Council, which represents large PFAS manufacturers such as 3M, disagrees with those calling for the entire class of PFAS chemicals to be banned. “Individual chemistries have their own unique properties and uses, as well as environmental and health profiles,” said Tom Flanagin, a spokesperson for the trade group.

While the council’s member companies “support strong, science-based regulations of PFAS chemistries that are protective of human health and the environment,” Flanagin said, the rules shouldn’t harm economic growth “or hamper businesses and consumers from accessing the products they need.”

For their part, some environmental advocates welcome the reporting proposal, expecting it to reveal new and surprising uses of PFAS. “However, it’s going to be a snapshot,” said Sonya Lunder, the senior toxics policy adviser for the Sierra Club.

Lunder said even if PFAS were found in, for example, brands of baby bibs, pesticide containers, or pet food bags, it isn’t clear which federal agency would regulate the products. She said Americans should demand that Congress add PFAS and other harmful chemicals to all major environmental statutes for water, air, food, and consumer products.

And another worry: If the data does make it into the mainstream, will consumers simply tune it out — just as many do with California’s multitudinous cancer warning signs? Lunder doesn’t think so, since “the audience is scientists, regulators, and — for better or for worse — tort attorneys.”

Benesh, of the Environmental Working Group, said the disclosures could reach further and “embolden consumers to demand even more market change.”

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The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.

Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.

Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms. But at times, she said, her treatments were delayed due to UnitedHealthcare’s white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.

“I once had to use a toilet lift and it was kind of demoralizing to say, ‘I’m a 50-year-old woman and I have to use a toilet lift,’” Shepard said of the medication delays.

This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. While insurers claim the arrangement reduces costs, she said, that doesn’t mean insurers pass along savings to patients.

“I don’t think we should have more sympathy toward one party or the other,” Bai said. “Nobody is better than the other. They’re all trying to make money.”

The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn’s, cost on average $1,106 per unit in 2015 under hospitals’ traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.

Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center’s size has helped it largely avoid such insurer policies.

John DiPersio, a Siteman oncologist and researcher who led the university’s oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.

“You’re talking about cancer patients that are getting life-threatening treatments,” DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. “It doesn’t make any sense to me. It’s all stupid. It’s all lunacy.”

At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, Louisiana, and Virginia.

ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.

“This is a major issue,” said Tom Kraus, a vice president at the trade group. “We see this as central to our ability to coordinate patient care.”

At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.

The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.

The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation’s roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug’s cost, according to the Health Resources & Services Administration, which oversees the program.

The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.

“The fact is, people got greedy,” Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas City, said during a Missouri state Senate hearing in March.

Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America’s Health Insurance Plans. The markups thrusted on commercial plans are “widely out of line” with what Medicare will pay, he said, and that is driving up costs without providing additional value.

Legislation that targets white bagging hinders an insurer’s ability to rein in such costs, Dickson said, especially when an area lacks competition.

“What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety,” Dickson said.

Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.

For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly’s recent session.

Shepard, though, won’t need such legislation.

UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens’ in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a “bureaucratic mess” trying to get the medication shipped.

“We are driving unnecessary costs out of the health care system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care,” UnitedHealthcare spokesperson Tony Marusic wrote.

But after KFF Health News inquired about Shepard’s case, Marusic said UnitedHealthcare stopped white bagging Shepard’s medication to “prevent potential delays in shipping.” And during her latest infusion in June, her hospital was again able to supply Shepard’s medication directly.

“I'm just so relieved,” Shepard said. “I don't have to take phone calls. I don't have to reply to emails. I just show up.”

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Babe lives a quiet life on a hillside farm in southern Iowa, where she grazes on grass with a small herd of fellow goats. Her owner, Stacy Wistock, milks her twice a day.

Wistock takes precautions to keep the milk clean, but she rarely pasteurizes it. Until recently, she gave it away to family and friends. Now, she’ll make a little money off it. Iowa legislators decided this spring to join dozens of other states in allowing small producers to sell unpasteurized milk from cows, goats, and sheep.

Public health authorities and major dairy industry groups oppose the practice, saying such milk can be tainted with dangerous bacteria, including E. coli, salmonella, and listeria. But in state after state, those warnings have been overwhelmed by testimonials from fans of “raw milk,” who contend pasteurized milk is more difficult to digest because the process alters enzymes and kills helpful bacteria.

Federal experts say there is no proof that pasteurization makes milk less healthful. People on all sides of the issue say the rising interest in raw milk is fueled partly by distrust of public health authorities, which grew during the covid-19 pandemic.

Wistock is unsure about some of the health claims made by ardent raw milk fans. But she sees the issue as a matter of freedom. “I don’t like restrictive laws about what foods you can and can’t sell to your neighbors,” she said.

Iowa’s new law, which took effect July 1, allows only direct sales from small producers to consumers. The law is stricter than those in several other states, which allow raw milk sales in stores.

Pasteurization, developed in the 1800s, involves heating milk to kill bacteria. The practice was widespread by 1950, helping rein in deadly diseases, including tuberculosis, typhoid, and scarlet fever, according to the Centers for Disease Control and Prevention.

“Most public health professionals and health care providers consider pasteurization to be one of public health’s most effective food safety interventions ever,” the CDC’s website says. It warns that consumption of unpasteurized milk has sparked outbreaks of food poisoning, which can cause diarrhea, vomiting, kidney failure, and even death.

Iowa: A Case Study in Raw Milk’s Evolving Legal Landscape

Eric Heinen, an environmental health officer for northern Iowa’s Black Hawk County, is among the public health officials who worked for years to keep raw milk sales illegal.

He was discouraged but not shocked to see Iowa’s raw milk proposal pass this spring amid growing skepticism of science. “It’s a different atmosphere we’re in right now,” he said.

Heinen said he has no objection to informed adults risking their health by consuming raw milk. But he wishes it weren’t being given to young children, who are particularly susceptible to complications.

He has heard proponents argue that humans got along fine for thousands of years while drinking unpasteurized milk and going without vaccinations. “Then again, the life span 2,000 years ago was a lot less than it is today,” he said, and many more children used to die as infants or toddlers.

Iowa legislators repeatedly rebuffed proposals to legalize raw milk over the past 17 years. The idea finally cleared the Republican-controlled legislature this spring and was signed into law by Republican Gov. Kim Reynolds.

The leading statehouse sponsor, Republican Sen. Jason Schultz, noted during debate that under the bill, raw milk dairies may have no more than 10 animals giving milk. Producers must test the animals monthly for bacteria. The unpasteurized milk must be sold directly from producers to consumers. It can’t be offered in stores, restaurants, or farmers markets. Containers must include labels noting the milk is unpasteurized and has not been inspected by the government.

“By limiting the size of the farm and the methods of distribution, this bill will meet the niche market demand while requiring strong local connections between consumers and producers,” Schultz said during floor debate.

Schultz expressed delight in formally asking his colleagues to “mooooove” the bill to final passage.

The bill was earlier criticized on the Iowa House floor by Rep. Megan Srinivas, a Democrat and infectious disease physician. Srinivas recounted treating children who were seriously sickened by germs in unpasteurized milk.

“Raw milk increases chances of infection by 150 times,” Srinivas told her colleagues. Infected people can then pass on germs, including hepatitis A, shigella, and E. coli, when handling other people’s food, she said. “These outbreaks have public health implications that we cannot ignore.”

A national group, the Weston A. Price Foundation, advises activists who lobby for raw milk legalization in statehouses across the country.

The foundation’s president, Sally Fallon Morell, said that when her group launched its website in 1999, 27 states allowed any sales of raw milk. Only a few states still totally ban it, she said.

Fallon Morell lives in rural Maryland, where she raises Jersey cows and complies with her state’s regulations by selling raw milk with labels saying it is for pets. “There’s no law against eating pet food,” she said.

She contends the public health establishment supports an “industrial system” of farming, and she disputes official reports of raw milk being tied to outbreaks of food poisoning.

From Curious Consumer to Staunch Critic

A vocal opponent of unpasteurized milk acknowledged in an interview that the other side is winning across the nation. “Public health has lost the war on raw milk,” said Mary McGonigle-Martin, a board member of a national food-safety group called Stop Foodborne Illness.

McGonigle-Martin, who lives in California, testified four times over several years against legalization proposals in the Iowa Legislature. She recounted how her son, Chris, became critically ill after drinking raw milk tainted with E. coli in 2006.

McGonigle-Martin said in a recent interview that she bought the milk at a health food store because she hoped a natural diet would help her son, who had attention-deficit/hyperactivity disorder. But Chris, who was 7, became severely ill less than three weeks after starting to drink it.

He spent two months in the hospital, and doctors had to put him on a ventilator and kidney dialysis while his body fought off toxins produced by the bacteria.

McGonigle-Martin wants states that allow sales of raw milk to require testing and training to reduce the danger. Iowa legislators added some precautions before their bill passed, she said, but they didn’t include strong enforcement provisions.

She favors the Iowa law’s 10-animal limit for raw milk producers, but she worries the provision could encourage untrained hobbyists to get into the business. “Producing raw milk is not like growing vegetables in your backyard and selling them,” she said.

Raw milk distribution isn’t totally new in Iowa. Before the law went into effect, several Iowa producers posted online that they offered it via “herd shares.” Under such arrangements, customers purchase a share of a herd, then receive a portion of its milk from the farmer. Proponents contend it’s legal because people are allowed to drink raw milk from their own animals.

Several states have laws explicitly allowing or banning herd share distribution of raw milk. Iowa has no such law, although a spokesperson for the Iowa Department of Agriculture and Land Stewardship said the agency has considered such arrangements to be unpermitted sales of the product.

States have widely varying laws on raw milk, said Alexia Kulwiec, a Wisconsin lawyer and executive director of the Farm-to-Consumer Legal Defense Fund, which advocates for legalization. Some state laws contain language seeming to allow limited distribution but still make it nearly impossible, she said. Florida, Hawaii, Maryland, New Jersey, Nevada, and Wisconsin have some of the highest hurdles, Kulwiec said.

Before Iowa allowed raw milk sales, some consumers loaded coolers into their cars and traveled to neighboring states to buy it. Supriya Jha, a software engineer from the central Iowa town of Runnells, is among them.

Jha has driven monthly to Missouri to buy unpasteurized cow milk for her toddler. The round trip is nearly 200 miles. She plans to buy goat milk from Wistock’s Iowa farm now that it’s legal.

Jha believes properly produced raw milk is healthful and easier for children to digest than pasteurized milk. She said she looks into how raw-milk producers operate before she buys from them. She plans to try some of Wistock’s goat milk herself to see how her body reacts before she feeds it to her daughter.

Jha grew up in India, where, she said, manufacturers are less aggressive in hawking highly processed foods. “I wanted to raise my baby with the old ways,” she said. She also is skeptical of many vaccines that most doctors and public health leaders urge for children. “I don’t trust the medical establishment,” she said, adding she thinks the system pushes profitable products and treatments. “It’s a racket.”

Back at Wistock’s farm, Babe will soon be joined by a few more nanny goats that are ready to be milked. Wistock, who works a full-time remote office job, figures she can make a small profit on the side by milking four goats and selling the milk for $6 a half-gallon jar.

Wistock already runs bacterial tests on milk for her own use, so it won’t be a big adjustment to follow the state’s new testing rules. She has built a small milking parlor in a trailer, complete with a vinyl floor that’s easy to scrub. Before milking, she cleans the goat’s teats with an antiseptic spray and paper towels. Her containers are washed in a dishwasher, then sanitized in a UV light chamber. She catches the milk in a stainless-steel pitcher and strains it through a filter into glass jars.

After collection, Wistock uses her freezer to chill the milk to 38 degrees, then she places it in the refrigerator. She sometimes pasteurizes goat milk before she turns it into cheese, “just to be safe.”

Wistock is confident that the raw milk she’ll sell is clean, but she knows any food product can carry risks. She’s not sure she would feed it to young children or people with weak immune systems. But she won’t ask what her customers plan to do with it. “I’m not going to tell other people what to drink,” she said.

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

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 health benefit.”

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.”

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-Free Kids President Matthew L. Myers supports the development 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.

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 decision.

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.

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 challenge 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.”

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.”

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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After surgery left her husband partially paralyzed, he needed to use disposable underwear at least three times a day, said Bloxom, 72. Living on a fixed income, the couple couldn’t afford them.

Bloxom’s husband is among the estimated 2.5 million older Floridians who use incontinence products, like pads and adult diapers, daily. But with over a tenth of the Sunshine State’s seniors living in poverty, many struggle to pay for the supplies they need.

Last month, Florida joined a growing number of states that are banning sales taxes on diapers to make them more affordable for older adults and families with young children. Florida is one of the United States’ top three destination states for retirees, with about 21% of its residents age 65 or older.

“So it affects more people in Florida than it does in other places,” said state Sen. Jay Trumbull, a Republican.

Fifteen other states, including California, Louisiana, and Minnesota, as well as the District of Columbia, have permanently eliminated the diaper tax, according to the National Diaper Bank Network. (Five others do not have sales taxes in general.)

Exemptions can vary widely. Some states ban taxes on diapers but no other incontinence products; others exempt taxes only on diapers purchased with a doctor’s prescription. Florida’s effort is particularly comprehensive — eliminating sales taxes on both baby diapers and adult incontinence supplies.

The measure will reduce the state’s general revenue by about $54.4 million annually after its first year, according to a Florida Senate analysis. That money could make a huge difference in the lives of everyday Floridians, said Rima Nathan, a professor and the director of the Claude Pepper Elder Law Clinic at Florida State University.

Eliminating taxes on the products could save an adult who uses four or five diapers a day about $18 a month, according to a clinic analysis.

Though diapers, including for babies, are essential for many, they are not covered by food stamps. Nor are incontinence products for older adults typically covered by Medicare.

The cost can easily add up on a fixed income.

The Bloxoms receive $2,500 a month through Social Security. With medical copays, groceries, and mortgage payments, the money dries up quickly, Shirley Bloxom said.

Bloxom, who lives in Tallahassee, said she knows too many friends who have sat in unchanged incontinence products, stretching their luck and resources thin because money was tight.

“This stuff does not come cheap,” she said. “I can understand why some people let their loved ones sit there in that kind of condition. Because they don’t have the money.”

Karla Muñoz, a manager of aging services for Florida’s Hillsborough County, said the region’s older adults can spend about $100 a month on incontinence products. About half of the low-income seniors served by the county rely on these supplies, she said.

Lacking clean diapers can have a social cost. Seniors may avoid activities with grandchildren or friends, putting them at risk of isolation, which is linked to poorer health outcomes.

“Sometimes, they’ll have a tendency to use them a little bit longer, and that poses health risks,” Muñoz said. “They could develop bedsores, and now you’re talking about hospitalizations.”

Eliminating sales taxes has long been considered a way to make essential items more affordable. Many states, including Florida, have removed taxes on period products, for example.

For the past year, the Sunshine State has had a temporary pause on taxing diapers for infants, through a relief package Republican Gov. Ron DeSantis signed last May. But the one-year ban did not apply to products for older adults.

“I just didn’t think it was fair to ignore one over the other — especially knowing many seniors are on a fixed income,” said state Rep. Anna Eskamani, a Democrat, who has proposed bills in the past three legislative sessions that would ban taxes on all incontinence products. “Every penny does count.”

This year’s tax bill, which sailed through the Florida Legislature owing to a bipartisan push, made the diaper tax ban permanent — and extended it to senior incontinence products.

The relief package provides a sales tax exemption for diapers, incontinence undergarments, pads, and liners. DeSantis signed it into law on May 25.

The Sunshine State joined Iowa, Virginia, and North Dakota in permanently banning sales taxes on diapers this year.

The Bloxoms were eventually connected to Elder Care Services, a local nonprofit that provides support to low-income seniors in northeastern Florida. Because of the program, they no longer pay for diapers.

“It has been a lifesaver,” Shirley Bloxom said.

This article was produced in partnership with the Tampa Bay Times. The Foundation for a Healthy St. Petersburg also provided funding for this report.

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

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Lucia Agajanian, a 25-year-old freelance film producer in Chicago, doesn’t have a specific primary care doctor, preferring the convenience of visiting a local clinic for flu shots or going online for video visits. “You say what you need, and there’s a 15-minute wait time,” she said, explaining how her appointments usually work. “I really liked that.”

But Olga Lucia Torres, a 52-year-old who teaches narrative medicine classes at Columbia University in New York, misses her longtime primary care doctor, who kept tabs for two decades on her conditions, including lupus and rheumatoid arthritis, and made sure she was up to date on vaccines and screening tests. Two years ago, Torres received a letter informing her that he was changing to a “boutique practice” and would charge a retainer fee of $10,000 for her to stay on as a patient.

“I felt really sad and abandoned,” Torres said. “This was my PCP. I was like, ‘Dude, I thought we were in this together!’”

The two women reflect an ongoing reality: The primary care landscape is changing in ways that could shape patients’ access and quality of care now and for decades to come. A solid and enduring relationship with a primary care doctor — who knows a patient’s history and can monitor new problems — has long been regarded as the bedrock of a quality health care system. But investment in primary care in the U.S. lags that of other high-income countries, and America has a smaller share of primary care physicians than most of its European counterparts.

An estimated one-third of all physicians in the U.S. are primary care doctors — who include family medicine physicians, general internists, and pediatricians — according to the Robert Graham Center, a research and analysis organization that studies primary care. Other researchers say the numbers are lower, with the Peterson-KFF Health System Tracker reporting only 12% of U.S. doctors are generalists, compared with 23% in Germany and as many as 45% in the Netherlands.

That means it’s often hard to find a doctor and make an appointment that’s not weeks or months away.

“This is a problem that has been simmering and now beginning to erupt in some communities at a boil. It’s hard to find that front door of the health system,” said Ann Greiner, president and CEO of the Primary Care Collaborative, a nonprofit membership organization.

Today, a smaller percentage of physicians are entering the field than are practicing, suggesting that shortages will worsen over time.

Interest has waned partly because, in the U.S., primary care yields lower salaries than other medical and surgical specialties.

Some doctors now in practice also say they are burned out, facing cumbersome electronic health record systems and limits on appointment times, making it harder to get to know a patient and establish a relationship.

Others are retiring or selling their practices. Hospitals, insurers like Aetna-CVS Health, and other corporate entities like Amazon are on a buying spree, snapping up primary care practices, furthering a move away from the “Marcus Welby, M.D.”-style neighborhood doctor. About 48% of primary care physicians currently work in practices they do not own. Two-thirds of those doctors don’t work for other physicians but are employed by private equity investors or other corporate entities, according to data in the “Primary Care Chartbook,” which is collected and published by the Graham Center.

Patients who seek care at these offices may not be seen by the same doctor at every visit. Indeed, they may not be seen by a doctor at all but by a paraprofessional — a nurse practitioner or a physician assistant, for instance — who generally works under the supervision of a licensed physician. That trend has been accelerated by new state laws — as well as changes in Medicare policy — that loosen the requirements for physician supervisors and billing. And these jobs are expected to be among the decade’s fastest-growing in the health sector.

Overall, demand for primary care is up, spurred partly by record enrollment in Affordable Care Act plans. All those new patients, combined with the low supply of doctors, are contributing to a years-long downward trend in the number of people reporting they have a usual source of care, be it an individual doctor or a specific clinic or practice.

Researchers say that raises questions, including whether people can’t find a primary care doctor, can’t afford one, or simply no longer want an established relationship.

“Is it poor access or problems with the supply of providers? Does it reflect a societal disconnection, a go-it-alone phenomenon?” asked Christopher Koller, president of the Milbank Memorial Fund, a foundation whose nonpartisan analyses focus on state health policy.

For patients, frustrating wait times are one result. A recent survey by a physician staffing firm found it now takes an average of 21 days just to get in to see a doctor of family medicine, defined as a subgroup of primary care, which includes general internists and pediatricians. Those physicians are many patients’ first stop for health care. That runs counter to the trend in other countries, where patients complain of months- or years-long waits for elective procedures like hip replacements but generally experience short waits for primary care visits.

Another complication: All these factors are adding urgency to ongoing concerns about attracting new primary care physicians to the specialty.

When she was in medical school, Natalie A. Cameron said, she specifically chose primary care because she enjoyed forming relationships with patients and because “I’m specifically interested in prevention and women’s health, and you do a lot of that in primary care.” The 33-year-old is currently an instructor of medicine at Northwestern University, where she also sees patients at a primary care practice.

Still, she understands why many of her colleagues chose something else. For some, it’s the pay differential. For others, it’s because of primary care’s reputation for involving “a lot of care and paperwork and coordinating a lot of issues that may not just be medical,” Cameron said.

The million-dollar question, then, is how much does having a usual source of care influence medical outcomes and cost? And for which kinds of patients is having a close relationship with a doctor important? While studies show that many young people value the convenience of visiting urgent care — especially when it takes so long to see a primary care doctor — will their long-term health suffer because of that strategy?

Many patients — particularly the young and generally healthy ones — shrug at the new normal, embracing alternatives that require less waiting. These options are particularly attractive to millennials, who tell focus groups that the convenience of a one-off video call or visit to a big-box store clinic trumps a long-standing relationship with a doctor, especially if they have to wait days, weeks, or longer for a traditional appointment.

“The doctor I have is a family friend, but definitely I would take access and ease over a relationship,” said Matt Degn, 24, who says it can take two to three months to book a routine appointment in Salt Lake City, where he lives.

Patients are increasingly turning to what are dubbed “retail clinics,” such as CVS’ Minute Clinics, which tout “in-person and virtual care 7 days a week.” CVS Health’s more than 1,000 clinics inside stores across the U.S. treated more than 5 million people last year, Creagh Milford, a physician and the company’s senior vice president of retail health, said in a written statement. He cited a recent study by a data products firm showing the use of retail clinics has grown 200% over the past five years.

Health policy experts say increased access to alternatives can be good, but forgoing an ongoing relationship to a regular provider is not, especially as people get older and are more likely to develop chronic conditions or other medical problems.

“There’s a lot of data that show communities with a lot of primary care have better health,” said Koller.

People with a regular primary care doctor or practice are more likely to get preventive care, such as cancer screenings or flu shots, studies show, and are less likely to die if they do suffer a heart attack.

Physicians who see patients regularly are better able to spot patterns of seemingly minor concerns that could add up to a serious health issue.

“What happens when you go to four different providers on four platforms for urinary tract infections because, well, they are just UTIs,” posed Yalda Jabbarpour, a family physician practicing in Washington, D.C., and the director of the Robert Graham Center for Policy Studies. “But actually, you have a large kidney stone that’s causing your UTI or have some sort of immune deficiency like diabetes that’s causing frequent UTIs. But no one tested you.”

Most experts agree that figuring out how to coordinate care amid this changing landscape and make it more accessible without undermining quality — even when different doctors, locations, health systems, and electronic health records are involved — will be as complex as the pressures causing long waits and less interest in today’s primary care market.

And experiences sometimes lead patients to change their minds.

There’s something to be said for establishing a relationship, said Agajanian, in Chicago. She’s rethinking her decision to cobble together care, rather than have a specific primary care doctor or clinic, following an injury at work last year that led to shoulder surgery.

“As I’m getting older, even though I’m still young,” she said, “I have all these problems with my body, and it would be nice to have a consistent person who knows all my problems to talk with.”

KFF Health News’ Colleen DeGuzman contributed to this report.

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

USE OUR CONTENT

This story can be republished for free (details).