A team led by University of Pennsylvania scientists has discovered three genetic variants that offer the first strong clues as to why glaucoma disproportionately affects Black people.

The variants are common in people with African ancestry and are associated with a significantly higher risk of developing the sight-robbing disease, the researchers found in their study of more than 11,000 volunteers, including 6,300 from the Philadelphia area.

More research is needed to determine if these variants — each consisting of just a single “letter” among the 3 billion pairs of letters that spell out the human genome — play a direct role in causing glaucoma. But if they stand up to scrutiny, the findings someday could be used to develop better treatments and identify people who could benefit from them, said Shefali Setia Verma, one of the lead study authors and an assistant professor at Penn’s Perelman School of Medicine.

“The idea is that this can help identify individuals who are at higher risk before any symptoms occur,” she said.

Previous studies have found more than 170 other genetic variants that are involved in glaucoma, a condition in which the optic nerve becomes damaged, often as a result of increased pressure inside the eye. But most of those studies were conducted among white or Asian populations — despite the fact that glaucoma is more common in Black people and, when it occurs, is more likely to lead to blindness.

And most of the genetic variants discovered in those previous studies turned out to play little or no role in the disease for Black people, illustrating the need for diversity in study populations, said Penn physician-scientist Joan M. O’Brien.

“It was a hugely unmet need,” she said.

Gaining trust from Black patients

That’s what prompted O’Brien, Verma, and their colleagues to launch the new study, which is among the first — and by far the largest — conducted among Black people.

O’Brien blamed the shortage of studies partly on the justifiable misgivings that many Black people hold about medical research, citing examples of misconduct such as the Tuskegee experiment in which Black men were not treated for syphilis.

Ongoing bias in medicine continues to contribute to mistrust. For instance, Black patients are less likely than white patients to receive pain medication, and less likely to be admitted to the hospital from the emergency room. Until recently, they had to wait longer than white patients for a kidney transplant.

“Clearly there are reasons for individuals of African ancestry to distrust studies and distrust medicine and distrust many things related to science,” she said. “That doesn’t excuse us from trying to involve people of African ancestry.”

They ended up with 11,275 study participants, including the 6,300 that Penn physicians enrolled from the Philly area. The rest came from elsewhere in the United States, as well as Ghana and Nigeria, recruited by collaborators at other institutions.

The scientists started by comparing the genomes of study participants who had glaucoma with the genomes of participants who did not, identifying dozens of genetic variants that differed between the two groups.

Then winnowed down that list to the final three by conducting a series of laboratory studies in human cells. They also validated their findings by checking them against other genetic databases, including Penn Medicine’s own BioBank, a repository of blood and genetic samples of which 17% were contributed by Black people.

Glaucoma risk increase

All three variants were found in noncoding regions of the genome — what used to be erroneously referred to as “junk DNA,” or stretches of DNA that lie outside the genes. But as scientists have found in many other instances, these three variants, despite not being part of any gene, appear to play a role in the activity of nearby genes.

One of the variants was associated with a 75% increase in the risk of glaucoma. The other two each were linked to a 25% increase in risk of the disease.

The three variants appear to play some sort of causal role in the disease, but more work is needed to be sure what that is. O’Brien, director of the Penn Center for Genetics of Complex Disease, hopes that someday the findings could be incorporated into a rapid test, suitable for use in a primary-care office.

Such a test would allow physicians to identify and counsel at-risk patients before they are aware of any symptoms. People with the disease often are unaware they have it, as it typically starts with declining peripheral vision, which patients may not notice at first.

The genetic findings also could guide the development of better drugs, O’Brien said. Currently, physicians treat the disease by trying to lower the pressure inside patients’ eyes, first with medication and later, if needed, surgery.

But those tactics don’t work for everyone in whom the disease is caused by elevated eye pressure, O’Brien said. And in some cases, the disease can occur in people whose eye pressure is normal.

“We know it’s not just the pressure,” she said. “But that’s the only treatment we have to give.”

©2024 The Philadelphia Inquirer, LLC. Visit at inquirer.com. Distributed by Tribune Content Agency, LLC.

Jason George began noticing in September that Medicaid payments had stalled for some of his assisted living facility residents, people who need help with daily living.

Guardian Group Montana, which owns three small facilities in rural Montana, relies on the government health insurance to cover its care of low-income residents. George, who manages the facilities, said residents’ Medicaid delays have lasted from a few weeks to more than six months and that at one point the total amounted to roughly $150,000.

George said the company didn’t have enough money to pay its employees. When he called state health and public assistance officials for help, he said, they told him they were swamped processing a high load of Medicaid cases, and that his residents would have to wait their turn.

“I’ve mentioned to some of them, ‘Well what do we do if we’re not being paid for four or five months? Do we have to evict the resident?’” he asked.

Instead, the company took out bank loans at 8% interest, George said.

Montana officials finished their initial checks of who qualifies for Medicaid in January, less than a year after the federal government lifted a freeze on disenrollments during the height of the covid-19 pandemic. More than 127,200 people in Montana lost Medicaid with tens of thousands of cases still processing, according to the latest state data, from mid-February.

Providers who take Medicaid have said their state payments have been disrupted, leaving them financially struggling amid the unwinding. They’re providing care without pay, and sometimes going into debt. It’s affecting small long-term care facilities, substance use disorder clinics, and federally funded health centers that rely on Medicaid to offer treatment based on need, not what people can pay.

State health officials have defended their Medicaid redetermination process and said they have worked to address public assistance backlogs.

The problem is ongoing: George said two Guardian residents were booted from Medicaid in mid-March, with the state citing a lack of information as the cause.

“I have proof we submitted the needed information weeks ago,” he said.

Providers said they’ve also experienced cases of inconsistent Medicaid payments for people who haven’t lost coverage. It can be hard to disentangle why payments suddenly stop. Patients and providers are working within the same overstretched system.

Jon Forte is the head of the Yellowstone County health department in Billings, which runs health centers that provide care regardless of patients’ ability to pay. He said that at one point some of the clinics’ routine Medicaid claims went unpaid for up to six months. Their doctors are struggling to refer patients out for specialty care as some providers scale back on clientele, he said.

“Some have honestly had to stop seeing Medicaid patients so that they can meet their needs and keep the lights on,” Forte said. “It is just adding to the access crisis we have in the state.”

Payment shortfalls especially hurt clinics that base fees on patient income.

David Mark, a doctor and the CEO of One Health, which has rural clinics dotted across eastern Montana and Wyoming, said the company anticipated making about $500,000 in profit through its budget year so far. Instead, it’s $1.5 million in the red.

In Yellowstone County, Forte said, the health department, known as RiverStone Health, is down $2.2 million from its anticipated Medicaid revenue. Forte said that while state officials have nearly caught up on RiverStone Health’s direct Medicaid payments, smaller providers are still seeing delays, which contributes to problems referring patients for care.

Jon Ebelt, a spokesperson for the Montana Department of Public Health and Human Services, said Medicaid can retroactively pay for services for people who have lost coverage but are then found eligible within 90 days. He said the state’s average redetermination processing time is 34 days, the average processing time for applications is 48 days, and, when processing times are longer, it’s often due to ongoing communication with a client.

Ebelt didn’t acknowledge broader Medicaid payment delays, but instead said a provider may be submitting claims for Medicaid enrollees who aren’t eligible. He rejected the idea that individual examples of disruptions amount to a systemic problem.

“We would caution you against using broad brush strokes to paint a picture of our overall eligibility system and processes based on a handful of anecdotal stories,” Ebelt said in an emailed response to a KFF Health News query.

Ebelt didn’t directly answer questions about continued long waits for people seeking help but instead said continued coverage depends on individual beneficiaries submitting information on time.

Federal data shows Montana’s average call center wait time is 30 minutes — putting it among states with the highest average wait times. Mike White, co-owner of Caslen Living Centers, which has six small assisted living facilities across central and southwestern Montana, said some family members allowed the company to manage residents’ Medicaid accounts to help avoid missing deadlines or paperwork. Even so, he said, the company is waiting for about $30,000 in Medicaid payments, and it’s hard to reach the state when problems arise.

When they do get through to the state’s call center, the person on the other end can’t always resolve their issue or will answer questions for only one case at a time.

“You don’t know how long it’s going to take — it could be two months, it could be six months — and there’s nobody to talk to,” White said.

Ebelt said long-term care facilities were provided information on how to prepare for the unwinding process. He said new Medicaid cases for long-term care facilities are complicated and can take time.

Stan Klaumann lives in Ennis and has power of attorney for his 94-year-old mom, who resides in one of Guardian’s assisted living homes. Klaumann said that while she never lost coverage, the state didn’t make Medicaid payments toward her long-term care for more than four months and he still doesn’t know why.

He said that since last fall the state hasn’t consistently mailed him routine paperwork he needs to fill out and return in exchange for Medicaid payments to continue. He tried the state’s call center, he said, but each time he waited on hold for more than two hours. He made four two-hour round trips to his closest office of public assistance to try to get answers.

Sometimes the workers told him that there was a state error, he said, and other times that he was missing paperwork he’d already submitted, such as where money from selling his mom’s car went.

“Each time I went, they gave me a different answer as to why my mother’s bills weren’t being paid,” Klaumann said.

Across the nation, people have reported system errors and outdated contact information that led states to drop people who qualify. At least 28 states paused procedural disenrollments to boost outreach to people who qualify, according to federal data. Montana stuck to its original time frame and has a higher procedural disenrollment rate than most other states, according to KFF.

Stephen Ferguson, executive director of Crosswinds Recovery in Missoula, said the substance use disorder program doesn’t have a full-time person focused on billing and sometimes doesn’t realize clients lost Medicaid coverage until the state rejects thousands of dollars in services that Crosswinds submits for reimbursement. After that, it can take months for clients to either get reenrolled or learn they truly no longer qualify.

Ferguson said he’s writing grant proposals to continue to treat people despite their inability to pay.

“We’re riding by the seat of our pants right now,” he said. “We are unsure what next month or the next quarter looks like.”

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Steward Health Care, which owns nine hospitals in Massachusetts, announced that their plans to close New England Sinai to the state in December. Steward’s ongoing financial distress continue to threaten other Massachusetts hospitals, and with a strong push from the state, the company is looking to sell their remaining facilities in the state.

The closure will remove 39 rehabilitation service beds, 119 chronic care service beds, and all ambulatory care services at the hospital, Steward wrote in a 90-day notice to the Department of Public Health in January.

The notice noted New England Sinai’s financial performance has decreased by more than 1,600% over five years, citing the “chronic under-reimbursement rates through public programs like Medicaid,” increased labor and material costs and lingering effects of the COVID-19 pandemic.

The hospital was operating at about 40% capacity in 2024, the notice said, the hospital “does not anticipate a significant impact on patient access following the closure,” listing other rehabilitation and specialty care facilities in Stoughton, New Bedford, Braintree and Boston. All the patients were discharged ahead of the closure on Tuesday, Steward said previously.

Stoughton residents noted the impact of the closure Monday, noting family members, friends and neighbors treated.

“This is definitely a loss for the community,” said Leslie Baker, a long-term resident of the Stoughton area. “I haven’t been myself, but I know people who’ve been treated. And I knew a nurse who worked there. It was definitely an important place for many people.”

The Stoughton-based hospital traces its roots to 1927, when it opened as the nonprofit hospital Jewish Tuberculosis Sanatorium in Rutland, Massachusetts, according to the hospital site.

“Good Samaritan (Hospital in Brockton) is pretty close,” said Josh Miller. “But you can tell we can use more health care around here. For sure.”

The future of the facility is not yet certain, town officials said.

“Sinai Hospital has been a long term Corporate partner and a valuable contributor to our tax base,” Stoughton Town Manager Thomas Calter said Monday. “While they have kept us informed of their plan to close, they have provided no additional insight into their plans for the building. It is our hope that the real estate will remain a facility where Stoughton residents can benefit from their services and whereby it will continue to be a valuable asset benefiting the town of Stoughton.”

One January morning in 2021, Carol Rosen took a standard treatment for metastatic breast cancer. Three gruesome weeks later, she died in excruciating pain from the very drug meant to prolong her life.

Rosen, a 70-year-old retired schoolteacher, passed her final days in anguish, enduring severe diarrhea and nausea and terrible sores in her mouth that kept her from eating, drinking, and, eventually, speaking. Skin peeled off her body. Her kidneys and liver failed. “Your body burns from the inside out,” said Rosen’s daughter, Lindsay Murray, of Andover, Massachusetts.

Rosen was one of more than 275,000 cancer patients in the United States who are infused each year with fluorouracil, known as 5-FU, or, as in Rosen’s case, take a nearly identical drug in pill form called capecitabine. These common types of chemotherapy are no picnic for anyone, but for patients who are deficient in an enzyme that metabolizes the drugs, they can be torturous or deadly.

Those patients essentially overdose because the drugs stay in the body for hours rather than being quickly metabolized and excreted. The drugs kill an estimated 1 in 1,000 patients who take them — hundreds each year — and severely sicken or hospitalize 1 in 50. Doctors can test for the deficiency and get results within a week — and then either switch drugs or lower the dosage if patients have a genetic variant that carries risk.

Yet a recent survey found that only 3% of U.S. oncologists routinely order the tests before dosing patients with 5-FU or capecitabine. That’s because the most widely followed U.S. cancer treatment guidelines — issued by the National Comprehensive Cancer Network — don’t recommend preemptive testing.

The FDA added new warnings about the lethal risks of 5-FU to the drug’s label on March 21 following queries from KFF Health News about its policy. However, it did not require doctors to administer the test before prescribing the chemotherapy.

The agency, whose plan to expand its oversight of laboratory testing was the subject of a House hearing, also March 21, has said it could not endorse the 5-FU toxicity tests because it’s never reviewed them.

But the FDA at present does not review most diagnostic tests, said Daniel Hertz, an associate professor at the University of Michigan College of Pharmacy. For years, with other doctors and pharmacists, he has petitioned the FDA to put a black box warning on the drug’s label urging prescribers to test for the deficiency.

“FDA has responsibility to assure that drugs are used safely and effectively,” he said. The failure to warn, he said, “is an abdication of their responsibility.”

The update is “a small step in the right direction, but not the sea change we need,” he said.

Europe Ahead on Safety

British and European Union drug authorities have recommended the testing since 2020. A small but growing number of U.S. hospital systems, professional groups, and health advocates, including the American Cancer Society, also endorse routine testing. Most U.S. insurers, private and public, will cover the tests, which Medicare reimburses for $175, although tests may cost more depending on how many variants they screen for.

In its latest guidelines on colon cancer, the Cancer Network panel noted that not everyone with a risky gene variant gets sick from the drug, and that lower dosing for patients carrying such a variant could rob them of a cure or remission. Many doctors on the panel, including the University of Colorado oncologist Wells Messersmith, have said they have never witnessed a 5-FU death.

In European hospitals, the practice is to start patients with a half- or quarter-dose of 5-FU if tests show a patient is a poor metabolizer, then raise the dose if the patient responds well to the drug. Advocates for the approach say American oncology leaders are dragging their feet unnecessarily, and harming people in the process.

“I think it’s the intransigence of people sitting on these panels, the mindset of ‘We are oncologists, drugs are our tools, we don’t want to go looking for reasons not to use our tools,’” said Gabriel Brooks, an oncologist and researcher at the Dartmouth Cancer Center.

Oncologists are accustomed to chemotherapy’s toxicity and tend to have a “no pain, no gain” attitude, he said. 5-FU has been in use since the 1950s.

Yet “anybody who’s had a patient die like this will want to test everyone,” said Robert Diasio of the Mayo Clinic, who helped carry out major studies of the genetic deficiency in 1988.

Oncologists often deploy genetic tests to match tumors in cancer patients with the expensive drugs used to shrink them. But the same can’t always be said for gene tests aimed at improving safety, said Mark Fleury, policy director at the American Cancer Society’s Cancer Action Network.

When a test can show whether a new drug is appropriate, “there are a lot more forces aligned to ensure that testing is done,” he said. “The same stakeholders and forces are not involved” with a generic like 5-FU, first approved in 1962, and costing roughly $17 for a month’s treatment.

The fluoropyrimidine enzyme deficiency numbers are smaller — and people with the deficiency aren’t at severe risk if they use topical cream forms of the drug for skin cancers. Yet even a single miserable, medically caused death was meaningful to the Dana-Farber Cancer Institute, where Carol Rosen was among more than 1,000 patients treated with fluoropyrimidine in 2021.

Her daughter was grief-stricken and furious after Rosen’s death. “I wanted to sue the hospital. I wanted to sue the oncologist,” Murray said. “But I realized that wasn’t what my mom would want.”

Instead, she wrote Dana-Farber’s chief quality officer, Joe Jacobson, urging routine testing. He responded the same day, and the hospital quickly adopted a testing system that now covers more than 90% of prospective fluoropyrimidine patients. About 50 patients with risky variants were detected in the first 10 months, Jacobson said.

Dana-Farber uses a Mayo Clinic test that searches for eight potentially dangerous variants of the relevant gene. Veterans Affairs hospitals use a 11-variant test, while most others check for only four variants.

Different Tests May Be Needed for Different Ancestries

The more variants a test screens for, the better the chance of finding rarer gene forms in ethnically diverse populations. For example, different variants are responsible for the worst deficiencies in people of African and European ancestry, respectively. There are tests that scan for hundreds of variants that might slow metabolism of the drug, but they take longer and cost more.

These are bitter facts for Scott Kapoor, a Toronto-area emergency room physician whose brother, Anil Kapoor, died in February 2023 of 5-FU poisoning.

Anil Kapoor was a well-known urologist and surgeon, an outgoing speaker, researcher, clinician, and irreverent friend whose funeral drew hundreds. His death at age 58, only weeks after he was diagnosed with stage 4 colon cancer, stunned and infuriated his family.

In Ontario, where Kapoor was treated, the health system had just begun testing for four gene variants discovered in studies of mostly European populations. Anil Kapoor and his siblings, the Canadian-born children of Indian immigrants, carry a gene form that’s apparently associated with South Asian ancestry.

Scott Kapoor supports broader testing for the defect — only about half of Toronto’s inhabitants are of European descent — and argues that an antidote to fluoropyrimidine poisoning, approved by the FDA in 2015, should be on hand. However, it works only for a few days after ingestion of the drug and definitive symptoms often take longer to emerge.

Most importantly, he said, patients must be aware of the risk. “You tell them, ‘I am going to give you a drug with a 1 in 1,000 chance of killing you. You can take this test. Most patients would be, ‘I want to get that test and I’ll pay for it,’ or they’d just say, ‘Cut the dose in half.’”

Alan Venook, the University of California-San Francisco oncologist who co-chairs the National Comprehensive Cancer Network, has led resistance to mandatory testing because the answers provided by the test, in his view, are often murky and could lead to undertreatment.

“If one patient is not cured, then you giveth and you taketh away,” he said. “Maybe you took it away by not giving adequate treatment.”

Instead of testing and potentially cutting a first dose of curative therapy, “I err on the latter, acknowledging they will get sick,” he said. About 25 years ago, one of his patients died of 5-FU toxicity and “I regret that dearly,” he said. “But unhelpful information may lead us in the wrong direction.”

In September, seven months after his brother’s death, Kapoor was boarding a cruise ship on the Tyrrhenian Sea near Rome when he happened to meet a woman whose husband, Atlanta municipal judge Gary Markwell, had died the year before after taking a single 5-FU dose at age 77.

“I was like … that’s exactly what happened to my brother.”

Murray senses momentum toward mandatory testing. In 2022, the Oregon Health & Science University paid $1 million to settle a suit after an overdose death.

“What’s going to break that barrier is the lawsuits, and the big institutions like Dana-Farber who are implementing programs and seeing them succeed,” she said. “I think providers are going to feel kind of bullied into a corner. They’re going to continue to hear from families and they are going to have to do something about it.”

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Elizabeth Bauer was working out at the gym one morning last August when she got a phone call from her fertility nurse. It was a call that Bauer and her wife, Rebecca, had long been waiting for.

Elizabeth dialed in Rebecca so they could listen together: They were pregnant.

The Washington, D.C., couple decided before they got married three years ago that they wanted to have a child. Both wanted to play a biological part in the pregnancy. So, they used a process called reciprocal in vitro fertilization, through which eggs were retrieved from Rebecca and fertilized with donor sperm to create embryos. Then one of the embryos was implanted in Elizabeth’s uterus.

Elizabeth, a 35-year-old elementary school teacher, and Rebecca, a 31-year-old nonprofit consultant, had health insurance, but it wouldn’t cover the roughly $20,000 procedure, so they had to pay out of pocket.

But beginning next year, insurers providing coverage in D.C. will have to pay for IVF for beneficiaries, including same-sex couples, who can’t conceive on their own. Only seven states (Colorado, Delaware, Illinois, Maine, Maryland, New Jersey and New York) have similar mandates. However, a new definition of “infertility” could prompt other states to follow suit.

The American Society for Reproductive Medicine in October expanded the definition of infertility to include all patients who require medical intervention, such as use of donor gametes or embryos, to conceive as a single parent or with a partner. Previously, the organization defined infertility as a condition in which heterosexual couples couldn’t conceive after a year of unprotected intercourse.

The group emphasized the new definition should not “be used to deny or delay treatment to any individual, regardless of relationship status or sexual orientation.”

Dr. Mark Leondires, a reproductive endocrinologist and founder and medical director at Illume Fertility and Gay Parents To Be, said the new definition could make a huge difference.

“It gives us extra ammunition to say, ‘Listen, everybody who meets the definition of infertility, whether it’s an opposite-sex couple or same-sex couple or single person, who wants to have a child should have access to fertility services,’” he said.

At least four states (California, Connecticut, Massachusetts and Rhode Island) are currently weighing broader IVF coverage mandates that would explicitly include same-sex couples, according to RESOLVE: The National Infertility Association. Bills were introduced but failed to advance in Oregon, Washington and Wisconsin.

A recent policy shift at the federal level also might add to the momentum. Earlier this month, the departments of Defense and Veterans Affairs announced expanded IVF service benefits to patients regardless of marital status, sexual orientation or whether they are using donor eggs or sperm. The new policy follows a lawsuit filed in federal court last year.

“The federal government is the largest employer in the country, so if they’re providing these type of benefits, it definitely adds pressure on other employers and states to do the same,” said Betsy Campbell, RESOLVE’s chief engagement officer.

A total of 21 states have laws mandating that private insurers cover fertility treatments, but only 15 include at least one cycle of IVF in that mandate. Only New York and Illinois provide some fertility coverage for people who are insured through Medicaid, the state-federal program for people with low incomes and disabilities. Neither state covers IVF for Medicaid recipients.

100,000 babies

IVF involves collecting mature eggs from ovaries, using donated sperm to fertilize them in a lab, and then placing one or more of the fertilized eggs, or embryos, in a uterus. One full cycle of IVF can take up to six weeks and can cost between $20,000 and $30,000. Many patients need multiple cycles before getting pregnant.

Nearly 100,000 babies in the U.S. were born in 2021 through IVF and other forms of assisted reproductive technology, such as intrauterine insemination, according to federal data.

IVF continues to garner nationwide attention in the wake of the Alabama Supreme Court’s ruling last month that under state law, frozen IVF embryos are children, meaning patients or IVF facilities can be criminally charged for destroying them. The decision caused an uproar, and three weeks later Alabama Republican Gov. Kay Ivey signed a bill into law that provides criminal and civil immunity for IVF clinicians and patients.

Polly Crozier, director of family advocacy at GLBTQ Legal Advocates & Defenders, or GLAD, described the Alabama decision as “a shock to the system.” But Crozier said the reaction to it sparked a “bipartisan realization that family-building health care is important to so many people.”

Crozier praised the insurance mandates in Colorado, Illinois, Maine and Washington, D.C., for more explicitly including LGBTQ+ people. Maine’s law, for example, states that a fertility patient includes an “individual unable to conceive as an individual or with a partner because the individual or couple does not have the necessary gametes for conception,” and says that health insurers can’t “impose any limitations on coverage for any fertility services based on an enrollee’s use of donor gametes, donor embryos or surrogacy.”

Christine Guarda, financial services representative at the Center for Advanced Reproductive Services at the University of Connecticut School of Medicine, said more same-sex couples are seeking help starting families. One reason, she said, is that more large employers that provide insurance directly to their employees, such as Amazon, are including broad IVF coverage.

‘Elective procedure’?

But some lawmakers are skeptical of expanding the definition of infertility to include same-sex couples. That was evident at a hearing on the Connecticut bill earlier this month, where Republican state Rep. Cara Pavalock-D’Amato noted that “infertility isn’t necessarily elective, but having a baby is.”

“Now, we are changing definitions to cover elective procedures,” Pavalock-D’Amato said. “If we’re changing the definition for this elective procedure, then why not others as well?”

She added: “Infertility, whether you are straight or gay, up to this point has been a requirement. Now, is it through this bill that we are no longer requiring people to be sick? They no longer have to be infertile?”

But proponents of the change argue that extending IVF mandates to cover same-sex couples is a question of fairness.

“I don’t think anybody in the LGBTQ community is asking for more. They’re just asking for the same benefit, and it is discriminatory to say, ‘You don’t get the same benefit as your colleague simply because you have a same-sex partner,’” Leondires said in an interview.

“If you’re paying to the same health care system as the person sitting next to you, then you should have the same benefit,” he said.

Elizabeth and Rebecca Bauer, who are busy decorating a nursery and buying baby clothes, recognize that they were fortunate to have the money to pursue IVF even without insurance coverage, and that “there are plenty of people who don’t have the time or the ability.”

“There are so many ways that people who want to build a family might struggle,” Elizabeth said, adding that the previous infertility definition felt like a “pretty impossible barrier” for non-straight couples. “Insurance should make building a family possible for any person or persons who want to.”

Stateline is part of States Newsroom, a national nonprofit news organization focused on state policy.

©2024 States Newsroom. Visit at stateline.org. Distributed by Tribune Content Agency, LLC.

More than 20 migrant families have called Harborside Suites in South Yarmouth their home since last September, but the town’s Zoning Board of Appeals has declared the motel has violated a local bylaw that limits temporary stays to less than 30 days.

“We would move today if we could,” motel Attorney Mark Boudreau said during a meeting last week. “The migrants that are there, they are ready to move. A lot of them have work visas… They would like to get going so they can obtain work where they’re going to be.”

Building Commissioner Mark Grylls issued a violation notice to the motel – currently housing 27 families – last October, but he told the ZBA he had to have their blessing before he could start imposing fines.

Harborside Suites, on Route 28 in the popular summer vacation beach town, sought a reversal of the violation, pointing to state officials that had said that “emergency needs of migrant families supersede the occupancy requirements of local zoning.”

But ZBA Vice Chairman Sean Igoe countered that he’s not confident Gov. Maura Healey’s migrant state-of-emergency carries more weight than local ordinances.

In her declaration last August, Healey wrote: “To the cities and towns across the state, many of which have a rich history tied to waves of immigrants settling within their borders, I am encouraging their communities to keep welcoming those families who wish to resettle in all corners of Massachusetts.”

Igoe took exception to the governor’s wording before the ZBA voted to uphold Grylls’ violation notice. “She’s just urging the cities and towns, she’s not ordering us to do it,” he said.

The state Executive Office of Housing and Livable Communities did not immediately respond to a Herald request for comment on Saturday.

In January, the ZBA approved Harborside Suites maintaining the migrants as Boudreau had told members that the motel heard from the state that the families would be moved to a “larger facility in the Foxboro area” that would “provide better opportunities for food and room.”

Motels that housed migrants in Bourne and Wareham, which Boudreau represents, have been “completely evacuated,” the attorney said. The future shelter for the Yarmouth migrant families, he added, is “within a 20-mile radius of Foxboro.”

“Unfortunately, the property did not pass inspection and had some code violations so they have not moved,” Boudreau said last Thursday. “Everyone is aware in the motel that they will be moving as soon as the property is ready.”

The exact date when the families will be moving out is unclear, but in previous violations of the Yarmouth motel-stay ordinance, the ZBA has given 45 to 90 days depending on the situation, Grylls said.

“I don’t believe we’ve had circumstances like this,” he said.

Harborside Suites is the latest motel or hotel to be thrust into the spotlight of the Massachusetts migrant crisis.

A 26-year-old Haitian national, living at a Rockland motel housing migrants, was charged with aggravated rape of a 15-year-old girl who police described in a report as “disabled,” on March 14. A Hingham judge found Cory Alvarez dangerous a week later and ordered him held without bail.

Taunton officials in February sued the owners of the Clarion Hotel housing migrant families in that city for providing living quarters to nearly 450 people, more than 350-person capacity. The suit seeks over $100,000 in overdue civil fines.

House Speaker Ron Mariano has suggested that broad budget cuts could be on the table when lawmakers sit down next year to draft the fiscal year 2026 budget, fueled by the historically high cost of running the state-run shelters.

With an expected $932 million tab this fiscal year and $915 million in the next to maintain shelters, associated services, and keep municipal reimbursements on track, Mariano projected that a range of other programs could be on the chopping block and put the blame on the feds and their lack of action in solving the migrant crisis.

In his fight with the Yarmouth ZBA, Boudreau highlighted the state’s “great expense” while arguing that the emergency declaration and right-to-shelter law –  homeless families and pregnant women must be provided housing in the Bay State – took precedence over local ordinance.

“To the extent that there is a question of safety and a question of the adequacy of the rooms,” Boudreau said, “the Commonwealth has at great expense provided food, shelter, education, medicine and medical care. They’ve arrived legally, and my client is simply trying to cooperate with the town and the state in getting them moved.”

Since migrant families arrived at Harborside Suites last fall, Yarmouth firefighters responded to a flooding at the motel in January, and a 6-month-old baby was rushed to Cape Cod Hospital the day after they took up residence, according to the hyperlocal Hyannis News. The baby had  “phlegm coming from her mouth, with blood-tinged sputum, according to radio transmissions,” the hyperlocal Hyannis News reported.

Town leaders assured residents last December that there were no active cases of tuberculosis at the motel after a brief scare, the Cape Cod Times reported.

Yarmouth resident Cheryl Ball told the Herald Saturday she is “very pleased” with the ZBA’s decision and hopes it creates a precedent across the state.

“It’s draining our resources,” Ball said of the impact the migrant families have had on the town. “They’re a burden on our education system because we have to pay extra tax dollars to support them in our schools. We have emergency services that we are providing to the hotel that comes out of our tax money.”

Our cat spends a fair amount of time outside for six months of the year. He is a very good hunter, but he drives me crazy when he brings home dead animals he has caught. The range of species is quite impressive but why does he do this? Also, I heard that Easter plants are potentially dangerous. I’m involved with our church and am thinking about bringing some plants home after services on Easter Sunday. Should I be concerned? P.H.

Dear P.H.,

There are many plausible reasons for why your cat may bring his prey home. The most well accepted is that it is a survival instinct to bring home what they have hunted to provide for you in a place they feel at home. It’s almost as if the cat wants to share the prey with you, not that you would want to eat it!  A cat would do this if they had a group of other cats to share with, but you are it. What you observe is more prevalent with females as this is the way they teach their young to survive, if they have kittens. It is also thought that bringing home dead animals that he has caught is a way of showing you his gratitude for providing for him as you do. What is important is that captured and killed prey of various species may be diseased so one must carefully handle and dispose of any carcasses brought home.

If you want to reduce his deliveries, you can consider putting a bell on a collar that will alert any prey so they might get away before being caught. Alternatively, play with him more and tire him out or keep him inside. As for Easter lilies, these plants are highly toxic to cats if ingested, so it is best to avoid them all together or ensure that they are out of reach of the cat! The leaves and even the pretty pollen is dangerous and can cause irreversible and fatal kidney damage. I would avoid bringing the beautiful lilies home after church but, if you must bring some home, keep an eye on your cat. Any sign of vomiting can be a sign of an emergency nature needing to be seen by a veterinarian. Happy Easter!

Dr. John de Jong owns and operates the Boston Mobile Veterinary Clinic. He can be reached at 781-899-9994.

“To be transparent, it is the smell of human waste so our school smells like poop,” said Steven Benjamin, a middle school reading specialist and special education teacher.

Benjamin and a pair of colleagues brought the odor, which one of them described as smelling like a “deceased animal,” to light during a School Committee meeting this week as they called on district leadership to step forward to make the miserable experience go away.

The teachers shared their stories the same night that the committee advanced the district’s $1.5 billion budget proposal for next fiscal year. The budget includes a controversial swath of staffing and programming cuts called out by parents and educators.

Dearborn opened to great fanfare in 2018, with the grade 6-12 early college academy marking the first new school construction project in 15 years at the time in the district. Officials hailed the 128,000-square-foot facility in Roxbury’s Nubian Square as a model for future projects.

But for Benjamin’s third-floor classroom to be usable, the door needs to be fully open at all times, an air purifier running with the ionizer on, and windows open which he said resembles the “COVID days.”

Recently, Benjamin said he left for lunch and closed the door, leaving the air purifier running – a step that was not enough to prevent the smell from getting out of hand.

“A half hour later,” he said, “I got back with my students and the smell had built back up and was so foul that they refused to stay in the room, and I couldn’t blame them because it just wasn’t habitable.”

Benjamin taught his students in the hallway before they relocated elsewhere as the smell traveled outside the classroom. It took about 45 minutes for the smell to dissipate, he said.

“To be clear, I am not complaining about my school-based custodial and leadership teams,” Benjamin said. “They’ve both been very supportive and responsive. They’ve tried onsite fixes, they’ve communicated to facilities through the proper channels.

“I totally understand that plumbing issues are probably really complicated, cannot be fixed right away,” he added, “but this issue has been present the whole year, and we don’t have a permanent fix yet.”

Officials highlighted the school, before its opening, as being outfitted with flexible indoor and outdoor learning classrooms, two fabrication labs, a dance studio, a gymnasium, 3D printers, a media center, and laser die cutters as tools.

The facility — with about $37 million of the cost reimbursed by the Massachusetts School Building Authority — was the culmination of six years of planning, design and construction, officials praised.

With open, spacious classrooms, the building resembles a college facility and was designed to support the learning that happens inside with its focus on computer science, engineering, health and life sciences and college readiness.

Dearborn features a STEM Tech Career Academy that enables high schoolers to earn associate’s degrees and credentials in a six-year program focusing on science, technology, engineering, and math fields.

As a tenth-grade science teacher, Julia Kiely said her experience with the stench is even more profound.

Kiely’s second-floor room has seven sinks and two floor drains underneath a safety shower. She said colleagues discovered the stench emanating from the drains and “recommended the flushing of the drains with water somewhat regularly since the great volume of drains and pipes in my room increase the likelihood of my room experiencing the smell.

“Unfortunately, this is a bigger task than anticipated,” Kiely added. “The smell is so bad that students say they cannot learn in my classroom, they refuse to enter, and they spray perfumes and Febreze constantly which can further irritate sensitive noses, and they’ll cough and wince throughout class.”

The odor smells the worst on Mondays and Tuesdays after the drains dry up over the weekend, Kiely said. For it to dissipate, she said she runs all seven sinks between 10 and 20 minutes while filling 1,000 milliliters of water and pouring them over the drains constantly.

“The smell is unacceptable for student learning and my teaching,” Kiely said. “It is so intense that students say they can taste it.”

School Committee Vice Chairman Michael O’Neill is calling for action to be taken as soon as possible, and the timeline in solving the issue to be expedited.

“I hope we’re going to get some very professional plumbers out to a (new) building – a matter of fact, let’s get the contractors who built the building out there – and find out what the heck is going on there,” he told Superintendent Mary Skipper, in her second year of running the nearly 46,000-student district.

Officials have created a project group that has begun looking into the issue, Skipper said, adding Dearborn staff were slated to be updated on the plan by the end of the week.

“We are working, and we have to do testing and when we do the testing it has to be when no one is in the building,” she said. “There is a full group that is on this issue and are aware of this issue.”

A district spokesperson did not provide the Herald further information on Friday, with schools closed in observance of Good Friday.

Low concentrations of “sewer gas,” or hydrogen sulfide, can cause irritated eyes, nose, throat, and respiratory system, while moderate concentrations may lead to headache, dizziness, nausea, vomiting, according to Omega, an environmental management and hazardous materials consulting firm.

High concentrations may cause shock, convulsions, inability to breathe, rapid unconsciousness, coma, and even death, the firm states.

Carolyn Sesser, a Dearborn high school health teacher, also deals with the smell, and in some cases, students refuse to walk down the hallway to get to her first-floor classroom. She said the scent is not constant but one that pops up multiple times a day a week, and the exact timing is unpredictable.

“We know that our administration and custodian teams have already looked into this problem and have done all they can,” Sesser said. “At this point, there needs to be something done at the district level to address it.”

Online stores sprang up during the COVID-19 pandemic’s telehealth boom touting testosterone as a cure-all for men’s age-related illnesses — despite FDA rules issued years ago restricting such “low testosterone” advertising.

In ads on Google, Facebook, and elsewhere, testosterone telemedicine websites may promise a quick fix for sluggishness and low libido in men. But evidence for that is lacking, physicians said, and the midlife malaise for which testosterone is being touted as a solution is more likely caused by chronic medical conditions, poor diet, or a sedentary lifestyle. In fact, doctors urge caution— and the FDA recommends that all testosterone supplements carry a warning that they may increase the risk of heart attack and stroke.

Valid medical reasons do exist for treating some men with testosterone. The hormone as a medication has existed for decades, and today’s patients include men with hypogonadism, some transgender men who use it to help transition physically, and, sometimes, women dealing with menopausal symptoms. It has also been used for decades by bodybuilders and athletes to enhance strength.

However, online dispensaries can overplay the idea of what is sometimes called “male menopause,” or even “manopause,” to drive sales of highly profitable testosterone-boosting injectables, often ignoring safety guidelines that should prevent healthy men from using the hormone. Some of the websites target military veterans.

“I have seen ads online that do cross the line,” said Steven Nissen, a physician and the chief academic officer for the Heart, Vascular, and Thoracic Institute at the Cleveland Clinic. “For mood and low energy, prescribing testosterone provides little to no benefit. They are promoting testosterone for indications that are not on the label.”

Testosterone telehealth websites almost all cite one study published in 2002 by New England Research Institutes scientists who found testosterone levels drop 1% a year in men over 40. Stefan Schlatt, director of the Center for Reproductive Medicine and Andrology at the University of Muenster in Germany, said the data behind the statistic included older men in deteriorating health whose levels declined because of illnesses.

“Healthy men do not show a drop,” he said.

That 2002 study led to a flood of “low-T” ads on U.S. television — ads that were later banned by the FDA in a 2015 ruling that accused the pharmaceutical industry of exaggerating the low-T phenomenon to scare men into buying drugs. According to another study, the market for testosterone supplements stood at $1.85 billion in 2023.

The deluge of ads “has fueled demand for a largely uninsured product, allowing for high markups,” said Geoffrey Joyce, director of health policy at the USC Schaeffer Center for Health Policy & Economics and a research associate at the National Bureau of Economic Research. “The primary driver is manufactured demand.”

Barbara Mintzes, a professor of evidence-based pharmaceutical policy at the University of Sydney’s Charles Perkins Centre in Australia, said low testosterone should really be seen as a sign of a condition that needs to be treated. She said diabetes, heart disease, high blood pressure, obesity, exposure to toxic chemicals like PFAS, and stress can all reduce testosterone levels.

Male Excel’s ads on Google, for example, say TRT “improves mood” and “restores vitality.” And its site says testosterone treatment will provide “muscular definition,” “weight loss,” “explosive drive,” “deeper sleep,” and “restored energy” above a link to a free assessment on its online telehealth platform. Craig Larsen, the company’s CEO, did not reply to several attempts to contact him by phone and email.

Both Male Excel and Hone Health are among the sites that pitch to military veterans. Hone Health included a video of a veteran who said he was refused testosterone treatment by a Department of Veterans Affairs hospital.

Saad Alam, CEO and co-founder of Hone, said that his company is what he called a “conservative” player in the market. He said that Hone prescribes only to men who are hypogonadal and tests men every 90 days, unlike other companies that operate telehealth websites as what he called a “cash grab.”

“I agree that patients should be treated by their doctors. But the U.S. medical system isn’t at a point where it can service men who have this problem, and some endocrinologists would rather treat patients who are higher-profit,” Hone said. “That’s why people are coming to us.”

One popular form of TRT is injectable testosterone cypionate. According to the Medicare average sales price database, it costs $0.027 per milligram. Online purveyors who sell the drug directly to consumers in 200 mg/mL vials for an average price of $129 per month are charging the equivalent of $1.55 per mg — a markup of more than 50 times the average Medicare price.

According to a 2022 study, the TRT telehealth websites create a way to circumvent doctors who refuse to prescribe the hormone. In that study, Justin Dubin, a urologist at the Memorial Healthcare System in Florida, posed as an online mystery shopper. He reported an above-normal testosterone level, and stated his desire to start a family, even though such therapy can curb sperm production. But six of the seven unnamed online TRT clinics prescribed him testosterone via a medical professional.

“And that’s concerning,” Dubin said. “Telemedicine helps men with hypogonadism who might be too embarrassed to discuss erectile dysfunction. But we need to do a better job of understanding the appropriateness of care.”

Still, while the FDA doesn’t allow off-label marketing, it does allow such off-label prescriptions.

Off-label use of testosterone replacement has become especially commonplace among veterans. And among male service members who received TRT in 2017, fewer than half met the clinical practice guidelines, according to a report by the U.S. military.

Phil Palmer, a 41-year-old Marine Corps veteran who lives outside Charleston, South Carolina, said he pays out-of-pocket for bloodwork and prescriptions for a pellet skin-implant form of testosterone and for clomiphene, a drug that can help counter the male infertility that is a side effect of testosterone treatment. He said the treatment appeals to him and other veterans dealing with the aftermath of military service.

“The environment we served in and stress levels have a lot to do with it,” Palmer said. “We were exposed to burn pits. The military doesn’t teach you to eat well — we ate a lot of processed food.”

In medical settings, TRT can speed recovery of soldiers who have bone density issues or spinal cord injuries, said Mark Peterson, a professor of physical medicine and rehabilitation at the University of Michigan Medical School. But, he said, “for men in the normal-T range, using an online prescription to buy testosterone to reduce stomach fat can be counterproductive.”

Those who use it also risk having to take testosterone medication indefinitely, because TRT can cause the body to cease its own production of the hormone.

Palmer, who founded a nonprofit that helps veterans heal through exercise, nutrition, and mentorship, said the medication has been helpful for him but urges fellow veterans to seek care from their doctors rather than what he called “bro science” websites touting testosterone.

“It’s not a magic pill,” he said.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

Billy Abbott, a retired Army medic, wakes at 6 every morning, steps on the bathroom scale, and uses a cuff to take his blood pressure.

The devices send those measurements electronically to his doctor in Gulf Shores, Alabama, and a health technology company based in New York, to help him control his high blood pressure.

Nurses with the company, Cadence, remotely monitor his readings along with the vital signs of about 17,000 other patients around the nation. They call patients regularly and follow up if anything appears awry. If needed, they can change a patient’s medication or dosage without first alerting their doctor.

Abbott, 85, said he likes that someone is watching out for him outside his regular doctor appointments. “More doctors should recommend this to their patients,” he said.

Increasingly, they are.

Dozens of tech companies have streamed in, pushing their remote monitoring service to primary care doctors as a way to keep tabs on patients with chronic illnesses and free up appointment time, and as a new source of Medicare revenue.

But some experts say remote monitoring’s huge growth — spurred on during the covid-19 pandemic, when patients were hesitant to sit in crowded doctors’ waiting rooms — has outpaced oversight and evidence of how the technology is best used.

“It is the wild West where any patient can get it if a doctor decides it is reasonable or necessary,” said Caroline Reignley, a partner with the law firm McDermott Will & Emery who advises health providers.

In 2019, Medicare made it easier for doctors to bill for monitoring routine vital signs such as blood pressure, weight, and blood sugar. Previously, Medicare coverage for remote monitoring was limited to certain patients, such as those with a pacemaker.

Medicare also began allowing physicians to get paid for the service even when the monitoring is done by clinical staff who work in different places than the physician — an adjustment advocated by telemedicine companies.

In just the first two full years, remote monitoring services billed to Medicare grew from fewer than 134,000 to 2.4 million in 2021, according to federal records analyzed by KFF Health News.

Total Medicare payments for the four most common billing codes for remote monitoring rose from $5.5 million in 2019 to $101.4 million in 2021, the latest year for which data is available.

Part of the allure is that Medicare will pay for remote monitoring indefinitely regardless of patients’ health conditions as long as their doctors believe it will help.

For doctors with 2,000 to 3,000 patients, the money can add up quickly, with Medicare paying an average of about $100 a month per patient for the monitoring, plus more for setting up the device, several companies confirmed.

Medicare enrollees may face 20% in cost sharing for the devices and monthly monitoring, though certain private plans through Medicare Advantage and Medicare supplement policies may cover those costs. The government allowed insurers to waive the patient cost sharing during the pandemic.

About 400 doctors and other providers repeatedly billed Medicare for remote patient monitoring in 2019. Two years later, that had mushroomed to about 3,700 providers, according to Medicare data analyzed by KFF Health News. (The data tracks providers who billed more than 10 patients for at least one type of remote monitoring.)

Federal law enforcement officials say they are conducting investigations after a surge in complaints about some remote patient monitoring companies but would not provide details.

The Department of Health and Human Services’ Office of Inspector General in November issued a consumer alert about companies signing up Medicare enrollees without their doctors’ knowledge: “Unscrupulous companies are signing up Medicare enrollees for this service, regardless of medical necessity,” and bill Medicare even when no monitoring occurs.

In a statement to KFF Health News, Meena Seshamani, director of the federal Center for Medicare, part of the Centers for Medicare & Medicaid Services, did not say how CMS is ensuring only patients who can benefit from remote monitoring receive it. She said the agency balances the need to give patients access to emerging technology that can improve health outcomes with the need to combat fraud and make proper payments to providers.

While some small studies show remote monitoring can improve patient outcomes, researchers say it is unclear which patients are helped most and how long they need to be monitored.

“The research evidence is not as robust as we would like to show that it is beneficial,” said Ateev Mehrotra, a Harvard Medical School researcher.

A January report by the Bipartisan Policy Center, a Washington, D.C.-based think tank, warned about “a lack of robust evidence on the optimal use of remote monitoring” and said some policy and medical experts “question whether we are effectively ‘rightsizing’ the use of these services, ensuring access for patients who need it most, and spending health care dollars in effective ways.”

Denton Shanks, a medical director at the American Academy of Family Physicians, said remote monitoring helps patients manage their diseases and helps physician practices be more efficient. He has used it for the past two years as a doctor at the University of Kansas Health System.

It has worked well, he said, though sometimes it can be challenging to persuade patients to sign up if they have to pay for it.

“For the vast majority of patients, once they are enrolled, they see a benefit, and we see a benefit as their vital signs come in the normal range,” Shanks said.

The size of the market is tantalizing.

About two-thirds of the more than 66 million Medicare beneficiaries have high blood pressure, the most common metric monitored remotely, according to physicians and the monitoring companies.

“The patient need is so enormous,” Cadence CEO Chris Altchek said. The company has about 40 nurses, medical assistants, and other providers monitoring patients in 17 states. He said patients enrolled in remote monitoring experience a 40% reduction in emergency room visits. Cadence says 82% of its patients use the devices at least once every two days.

Timothy Mott, a family physician in Foley, Alabama, said valuable appointment times in his office open up as patients who previously needed vital signs to be checked there turn to remote monitoring.

Cadence nurses regularly contact Mott’s patients and monitor their readings and make changes as needed.

“I was concerned early on whether they were going to make the right decisions with our patients,” Mott said. “But over time the dosage changes or changes in medication they are making are following the best guidelines on effectiveness.”

At the six-month mark, about 75% of patients have stayed with the monitoring, Mott said.

The advantages are apparent even to some providers who do not get paid by Medicare to offer the service. Frederick Health, a Maryland health system, provides remote monitoring to 364 high-risk patients and estimates the program saves the nonprofit system $10 million a year by reducing hospital admissions and ER visits. That estimate is based on comparisons of patients’ Medicare claims before they started the program and after, said Lisa Hogan, who runs the program.

The hospital pays for the program and does not bill Medicare, she said.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

A recent tweak to a Medicaid formula could be behind the shake-up to inhaler products, a series of changes that have both benefited and harmed patients with asthma and chronic obstructive pulmonary disease, or COPD.

Three of the four major inhaler manufacturers have announced plans to cap patient copays for all their inhalers at $35 a month in recent weeks, in addition to lowering the list prices of some of those products. But one drugmaker also withdrew two popular children’s inhalers from the market, and the alternative is in short supply.

Boehringer Ingelheim, AstraZeneca PLC and GlaxoSmithKline, also known as GSK PLC, all announced the $35 monthly copay cap, which could significantly extend the impact of their current patient assistance programs. The companies have simultaneously cut list prices — the initial price before health plans negotiate discounts and rebates — for some, but not all, of their inhalers.

The drug companies say they’ve made the changes because they’re committed to helping patients. Some Democrats on Capitol Hill say it happened because of public pressure. But some drug pricing experts are pointing to a recent change in the formula of Medicaid’s mandatory drug rebate program as the reason. It’s the same reason experts pointed to when insulin manufacturers lowered their list prices, although those reductions were more widespread.

The rebate change can force drugmakers to actually pay Medicaid in some cases if list prices on older products outpace inflation. The effect is less severe on asthma products than it was on insulin, thanks to a 2009 ban on chlorofluorocarbons, a common propellant in old inhalers, that resulted in a wave of new inhalers with new patents.

Because the change to the Medicaid rebate formula penalizes older drugs with higher prices the most, the newer inhalers are less affected than older insulin products.

“They’re still playing the same game,” said Anna Kaltenboeck, a former Senate Finance Committee staffer under Oregon Democrat Ron Wyden who now leads ATI Advisory’s Prescription Drug Reimbursement Practice. “It just brought the ceiling on the game down a little bit. And they’re sort of diffusing it vis-a-vis the patients by giving them these copay coupons.”

The rebate change is tied to the change in list prices, though, not copays. Copay caps are important because they limit what patients pay — including, at least in this case, uninsured patients — but reducing list prices helps cut behind-the-scenes costs that are absorbed by the health care system.

The rebate change took effect in January. GlaxoSmithKline in January reduced the list price for its Advair Diskus and Advair HFA inhalers, while AstraZeneca also reduced the list price of Symbicort. Boehringer Ingelheim is also planning to cut the list prices for Spiriva HandiHaler and Atrovent HFA.

Other factors like Medicare’s new penalty for raising prices faster than inflation could also be driving the changes.

“Inhalers are prime examples, like insulin, of products where manufacturers have raised list prices over very long periods of time,” said Will Feldman, a pulmonary doctor with Brigham and Women’s Hospital and an instructor at Harvard Medical School.

He pointed to Boehringer Ingelheim’s decision to drop list prices on Spiriva HandiHaler, an older inhaler that now faces generic competition, and not its newer product, Spiriva Respimat.

“That product is far less likely to be impacted by the Medicaid rebate cap policy change than Spiriva HandiHaler,” he said.

Both Boehringer Ingelheim and AstraZeneca refuted the idea that the Medicaid rebate was behind the decision to cut list prices.

“We continually look at market dynamics to assess what more we can do to address barriers to access and affordability of our medicines to help patients living with respiratory diseases lead healthier lives,” an AstraZeneca spokesperson said.

Not all the developments were positive for patients. GlaxoSmithKline in January also discontinued Flovent HFA and Flovent Diskus, two of the few inhalers approved for children. Insurance coverage for the authorized generics can vary, and the only other major alternative, Organon’s Asmanex, is now in shortage because of increased demand.

“It is the perfect storm of what is wrong with our pharmaceutical system,” Feldman said. “And the end result is patients in some cases are suffering and not getting the products they need.”

GlaxoSmithKline did not say whether the rebate was the driving factor behind its pricing changes or the decision to discontinue the two inhalers, saying it “had been planning to discontinue the branded products for some time.”

“The price reductions build on our strong track record of increasing access and improving the affordability of its medicines including an ongoing commitment to responsible pricing,” a company spokesperson said.

Capping patient copays could greatly increase access to consumers as well, even though the drugmakers already offer patient assistance programs. Kaltenboeck pointed to the ongoing access issues for insulin despite the insulin makers’ long-standing assistance programs.

“We know that people were dying because they weren’t getting insulin,” she said, “which suggests to me that copay coupons and patient assistance programs aren’t reaching people to the extent that you want them to be reached.”

Public pressure

Senate Health, Education, Labor and Pensions Chairman Bernie Sanders, I-Vermont, singled out the four major manufacturers in January as part of an investigation into inhaler prices. On Friday, he took a victory lap in the wake of the drugmakers’ announcements to cap copays, saying “they’re beginning to catch on to the fact that the American people are sick and tired of paying astronomical prices for the prescription drugs they need to stay alive.”

He acknowledged that the companies are only lowering list prices on some products but stressed the importance of the copay caps to patients. He also attributed the drug companies’ announcements to the committee’s investigation and public backlash, rather than Medicaid’s rebate program.

“In this instance, we think it’s public pressure,” he said.

Additionally, Sanders urged the last of the four major manufacturers that hasn’t capped copays, Teva Pharmaceutical Industries Ltd., to follow suit. The company is smaller and more focused on generics, he said, but he hoped Teva executives would come around.

“They are considering it,” he said.

Teva did not respond to requests for comment.

In November, the Federal Trade Commission warned a number of drugmakers, including Teva and the other major inhaler manufacturers, that they had improperly listed patents in the Food and Drug Administration’s registry known as the Orange Book, which can help block competition from generic rivals.

Teva was one of several companies that refused to pull any of the patents the FTC challenged. On Friday, the FTC took another step against the manufacturer, filing an amicus brief in a patent infringement suit Teva brought against Amneal Pharmaceuticals Inc. for attempting to bring a generic version of its ProAir HFA to market. The FTC argues the patents that Teva is claiming are improperly listed.

The issues underscore the broader dynamics that lawmakers and regulators still face in unwinding the tangled drug pricing system. The copay caps are good for patients, Feldman said, but not nearly enough.

“It’s a Band-Aid on a problematic drug pricing system in our country,” he said.

The post Experts say Medicaid rebate change is behind inhaler price cuts appeared first on Roll Call.

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Almost all new parents go through it: the distress of hearing their child scream at the doctor’s office. They endure the emotional torture of having to hold their child down as the clinician sticks them with one vaccine after another.

“The first shots he got, I probably cried more than he did,” said Remy Anthes, who was pushing her 6-month-old son, Dorian, back and forth in his stroller in Oakland, California.

“The look in her eyes, it’s hard to take,” said Jill Lovitt, recalling how her infant daughter Jenna reacted to some recent vaccines. “Like, ‘What are you letting them do to me? Why?’”

Some children remember the needle pain and quickly start to internalize the fear. That’s the fear Julia Cramer witnessed when her 3-year-old daughter, Maya, had to get blood drawn for an allergy test at age 2.

“After that, she had a fear of blue gloves,” Cramer said. “I went to the grocery store and she saw someone wearing blue gloves, stocking the vegetables, and she started freaking out and crying.”

Pain management research suggests that needle pokes may be children’s biggest source of pain in the health care system. The problem isn’t confined to childhood vaccinations either. Studies looking at sources of pediatric pain have included children who are being treated for serious illness, have undergone heart surgeries or bone marrow transplants, or have landed in the emergency room.

“This is so bad that many children and many parents decide not to continue the treatment,” said Stefan Friedrichsdorf, a specialist at the University of California-San Francisco’s Stad Center for Pediatric Pain, speaking at the End Well conference in Los Angeles in November.

The distress of needle pain can follow children as they grow and interfere with important preventive care. It is estimated that a quarter of all adults have a fear of needles that began in childhood. Sixteen percent of adults refuse flu vaccinations because of a fear of needles.

Friedrichsdorf said it doesn’t have to be this bad. “This is not rocket science,” he said.

He outlined simple steps that clinicians and parents can follow:

• Apply an over-the-counter lidocaine, which is a numbing cream, 30 minutes before a shot.
• Breastfeed babies, or give them a pacifier dipped in sugar water, to comfort them while they’re getting a shot.
• Use distractions like teddy bears, pinwheels, or bubbles to divert attention away from the needle.
• Don’t pin kids down on an exam table. Parents should hold children in their laps instead.

At Children’s Minnesota, Friedrichsdorf practiced the “Children’s Comfort Promise.” Now he and other health care providers are rolling out these new protocols for children at UCSF Benioff Children’s Hospitals in San Francisco and Oakland. He’s calling it the “Ouchless Jab Challenge.”

If a child at UCSF needs to get poked for a blood draw, a vaccine, or an IV treatment, Friedrichsdorf promises, the clinicians will do everything possible to follow these pain management steps.

“Every child, every time,” he said.

It seems unlikely that the ouchless effort will make a dent in vaccine hesitancy and refusal driven by the anti-vaccine movement, since the beliefs that drive it are often rooted in conspiracies and deeply held. But that isn’t necessarily Friedrichsdorf’s goal. He hopes that making routine health care less painful can help sway parents who may be hesitant to get their children vaccinated because of how hard it is to see them in pain. In turn, children who grow into adults without a fear of needles might be more likely to get preventive care, including their yearly flu shot.

In general, the onus will likely be on parents to take a leading role in demanding these measures at medical centers, Friedrichsdorf said, because the tolerance and acceptance of children’s pain is so entrenched among clinicians.

Diane Meier, a palliative care specialist at Mount Sinai, agrees. She said this tolerance is a major problem, stemming from how doctors are usually trained.

“We are taught to see pain as an unfortunate, but inevitable side effect of good treatment,” Meier said. “We learn to repress that feeling of distress at the pain we are causing because otherwise we can’t do our jobs.”

Meier said she thinks the campaign to reduce needle pain and anxiety should be applied to everyone, not just to children.

“People with dementia have no idea why human beings are approaching them to stick needles in them,” she said. And the experience can be painful and distressing.

Friedrichsdorf’s techniques would likely work with dementia patients, too, she said. Numbing cream, distraction, something sweet in the mouth, and perhaps music from the patient’s youth that they remember and can sing along to.

“It’s worthy of study and it’s worthy of serious attention,” Meier said.

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

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

COVID-19 can damage your heart, even when the virus doesn’t directly infect cardiac tissue. That’s the latest from a recent study supported by the National Institutes of Health.

Published in the journal Circulation, the study observed the damaged hearts of patients with acute respiratory distress syndrome associated with the virus and determined that COVID-19 patients suffering from severe lung infections were at risk of heart damage. The findings may prove to be relevant to organs other than the heart and to viruses other than COVID-19, as well.

COVID-19 increases a person’s risk of heart attack and stroke. In fact, more than 50% of COVID-19 patients experience some inflammation or damage to the heart, according to imaging research.

But does the virus damage the heart because it directly infects heart tissue or because of systemic inflammation? The answer might save lives.

“This was a critical question and finding the answer opens up a whole new understanding of the link between this serious lung injury and the kind of inflammation that can lead to cardiovascular complications,” Michelle Olive, Ph.D., told the NIH. “The research also suggests that suppressing the inflammation through treatments might help minimize these complications.” Olive is associate director of the Basic and Early Translational Research Program at the National Heart, Lung, and Blood Institute.

To answer the question, researchers studied mice subjected to biological signals that mimicked lung inflammation.

©2024 The Atlanta Journal-Constitution. Visit at ajc.com. Distributed by Tribune Content Agency, LLC.

Being a newcomer at the time, I decided to get a sense of what was considered newsworthy and important by tracking age-related happenings in the print media. I clipped articles from four daily newspapers and occasional periodicals, cut and pasted them (literally) on a sheet of paper, noted the source and date, punched three holes in the single sheet of paper and inserted the sheet into a three-ring binder. (Yes, this is history.) In addition to reading research studies and reports, I felt this was one way to be informed about what was happening “on the ground.” 

In year one, I barely filled one binder. As time passed, I was filling three to four binders a year. Enter the Internet. Cut and past became digital. Today, there is not a day that goes by in print or digital news that does not have several age-related stories. These stories cover public policy, health, longevity, nutrition, ageism, life extension, scientific discoveries, anti-aging, senior housing, products, services and more. 

With more people living longer and with greater needs and opportunities, the explosion of age-related information will only grow. 

Here is a snapshot of 5 areas of aging that are filling print and digital media, podcasts, webinars and reports that are commanding our attention. Note this is a bird’s eye overview from just one person’s perspective and is not based on formal analytics.  

Products: Let’s just focus on a few assistive technology products that help older adults age in their own residence as safely and independently as possible. Smart stoves and ovens can be set to turn off after five minutes of inactivity. Smart pill organizers dispense pills, others use lights to signal which pills to take (Carroself) and how many (Elliegrid). Activity-based sensors can detect if someone is not getting out of bed, opening the refrigerator door or medicine cabinet. (Sensors). 

Management practices: There are now five generations in the workforce, a first in modern history. According to Forbes magazine, a multigenerational workforce is a competitive advantage for several reasons. It is reported to increase productivity, support innovation and drive creative solutions. It provides learning/mentoring opportunities, enhances knowledge transfer and retention and contributes to job satisfaction according to the Academy to Innovate HR.

Appearances: More older notables are proud of their untouched appearances, essentially meaning no cosmetic surgery. “My mother was a great beauty and never succumbed to plastic surgery. She thought it was best to grow old gracefully. I feel the same,” Sigourney Weaver said in an interview last year with El País. For many, retaining one’s natural gray hair is one indicator of aging naturally.

Retirement planning: This popular subject can be foreboding. AARP reports that nearly half of those age 55 and older have no retirement savings. And nearly half (46 percent) of American households have no retirement savings in retirement accounts. Four in 10 workers are projected to fall short of what they need in retirement. 

Where to live: There currently are over 30,000 assisted living communities in the U.S. The need will continue to grow as 70 percent of older adults are predicted to need some kind of care in their lifetime. That care comes with a price tag of just over $57,000 median annual cost in 2023. https://www.seniorliving.org/companies/statistics/ This industry brings in just over $94 billion in revenue. 

Here’s an added fact. The magazine published by AARP (which was previously called “Modern Maturity”) reaches just over 38 million readers, making it the magazine with the largest circulation in the U.S.  

The broad field of aging continues to attract entrepreneurs, students, businesspeople, policymakers, researchers, scientists and more. As the population ages, the stakeholders will only continue to grow with most looking for ways to age well with a sense of stability, health and possibilities. 

Stay well everyone and know every act of kindness counts. 

Helen Dennis is a nationally recognized leader on issues of aging and the new retirement with academic, corporate and nonprofit experience. Contact Helen with your questions and comments at Helendenn@gmail.com. Visit Helen at HelenMdennis.com and follow her on facebook.com/SuccessfulAgingCommunity

State healthcare officials have received notifications in connection with the proposed sale of Stewardship Health Inc. and the contracting Steward Health Care Network to OptumCare, a subsidiary of UnitedHealth Group.

Stewardship Health Inc. is the parent of Stewardship Health Medical Group Inc., which employs primary care physicians and other clinicians across nine states, according to the state Health Policy Commission.

U.S. Rep. Jake Auchincloss raised immediate concerns with the proposal, which he called “alarming,” in a statement Wednesday morning after the development came to light Tuesday evening.

“Steward’s physician-led practices provide critical medical care to Greater Fall River & Greater Taunton and should continue to operate,” Auchincloss said. “But the prospect of UnitedHealth Group purchasing Stewardship Health is alarming. UnitedHealth, a Fortune 5 leviathan already under federal antitrust investigation, has spent five decades corporatizing healthcare to the detriment of patients and physicians.

“My constituents in southeastern Massachusetts should not be next in line,” he added.

Steward’s disastrous financial status, which came to the forefront earlier this year, continues to wreak havoc on Massachusetts hospitals and patients, some of whom live in the Bay State’s poorest communities.

The Dallas-based company which operates the third largest hospital system in Massachusetts admitted to being millions in debt in rent, with unpaid contracts and other expenses in January. Medical Properties Trust, Inc. owns the Steward facilities.

UnitedHealth faces its own trouble. The Wall Street Journal reported late last month that the country’s largest private health insurer is being sued by a California-based nonprofit group of hospitals and doctors over allegedly using its market power to try and force them to agree not to compete for primary care physicians.

The Department of Justice has launched an investigation of the healthcare conglomerate over antitrust concerns.

U.S. Sen. Ed Markey, hosting a news conference at the John F. Kennedy Federal Building Wednesday afternoon, highlighted how there could be “big consequences” if Steward’s sale to UnitedHealth goes through.

Markey will be leading a hearing that will “investigate” the role of for-profit companies in the country’s healthcare system next Wednesday in Boston.

The sale could lead to “an increase in costs, a reduction in services, but it could also mean that Optum, UnitedHealthcare, as it comes in to purchase these physician networks also bids away physicians who now work at community health centers, further hollowing out the healthcare services that are provided for the poorest in our state,” Markey said.

Before the sale can be completed, the Health Policy Commission must review the proposal.

The commission doesn’t have the authority to block a transaction but can refer findings to the state Attorney General’s office, the Department of Public Health, or other Massachusetts agencies for possible further action.

Documents filed with the state did not include a cost for the transaction. Under the deal, Optum would acquire a Steward affiliate that includes the company’s primary care doctors and other clinicians in nine states.

Transactions involving the sale of Steward’s eight Massachusetts hospitals would also require review by the agency, and review by the Determination of Need program at the Department of Public Health.

“This is a significant proposed change involving two large medical providers, both in Massachusetts and nationally, with important implications for the delivery and cost of health care across Massachusetts,” HPC Director David Seltz said.

Once all required information has been provided about the sale, the HPC will have 30 days to assess potential impacts of the transaction, according to the agency. If the sale is anticipated to have a significant impact on health care costs and market functioning, the HPC can initiate a full Cost and Market Impact Review, an option that it has often not pursued in the past.

House Speaker Ron Mariano believes the tentative sale could “significantly impact the competitiveness of the health care market” and “cause further disruption during a period of acute instability.”

“The HPC’s statutory authority to review the health care impacts of this transaction should not delay state and federal antitrust authorities from doing their own rigorous review as we all seek to protect patient access and affordability, communities, employees, and the overall health care system,” Mariano said in a statement.

Herald wire services contributed to this report

Community health centers and organizations that primarily serve low-income people are being disproportionately hurt by the biggest hack in health care history, which has disrupted payments for thousands of health care providers for a month now.

The hack, which crippled Change Healthcare, the clearinghouse for 30% of medical claims in the United States, has forced providers to find alternative funding sources to stay afloat. For large providers, like many health care systems, that comes in the form of reserves set aside for emergencies.

But for smaller providers, like many community health centers, that can mean taking out lines of credit, which can come with large interest rates, missing payments to vendors and seeking a hodgepodge of support from insurers that are willing to front payments.

“It’s been very tough for us,” said Robert Hilliard Jr., chief executive officer of Legacy Community Health, based in Houston.

Legacy, which has 57 clinics across Texas, processes about half of its claims through Change Healthcare. It currently has about eight figures in unpaid claims waiting to be processed, he said.

“We’ve had to extend a line of credit with a bank because we’ve had no funds” and negotiate with vendors on missed payments, Hilliard said.

The debate surrounding the Change Healthcare hack has largely been dominated by the impact on large health care systems, which move billions of dollars a day in claims. Americans spent $1.4 trillion on hospital care in 2022.

But in many cases, hospitals have more resources to weather emergencies like this. An analysis by KFF of 274 nonprofit hospitals and health systems found an average of 218 days’ cash on hand.

Fewer resources

But that’s not the case for many community health centers, which primarily see Medicaid patients, rely on grants and have thin operating margins. The national average of cash on hand for health centers in 2016 was 64 days, according to the latest data available.

UnitedHealth Group, which owns Change Healthcare, began testing systems this week for submitting claims. But the timeline for when it will be fully operational again is unclear. And processing claims that have been sitting around for a month will take time.

“I do worry that as big health care organizations come back online that people will stop caring as much about the impact on everybody who is left,” said Julia Skapik, medical director for informatics at the National Association of Community Health Centers.

While the Biden administration this week asked insurers to target advance payments to small, rural and safety-net health care providers facing cash flow issues, Skapik said that directive should have come earlier.

The federal government has been criticized for its slow response to the attack. While it has allowed providers to submit requests for advance Medicare fee-for-service payments, it can only encourage the private industry to do the same. That includes Medicare Advantage plans, which cover half of Medicare beneficiaries, and Medicaid Managed Care plans, which cover about 90% of Medicaid beneficiaries.

It’s not yet clear how successful the government’s request has been. Aside from UnitedHealth Group, which said it has directed $2 billion to providers, insurers have not publicly released information about how much financial assistance they have sent out.

Alliance of Community Health Plans, Association for Community Affiliated Plans, America’s Health Insurance Plans and Blue Cross Blue Shield Association wrote in a letter to Biden administration officials this week that they commit to “providing targeted advance payments to impacted providers in need.” They also wrote that they will engage in “proactive and data-driven outreach” to remaining providers facing operational challenges with claims processing or reimbursement and support providers switching to alternative services.

Blue Cross Blue Shield also told CQ Roll Call it is advancing payments to in-network providers.

In a separate letter, Medicaid Health Plans of America, which represents Medicaid managed care plans, also said its members are “committed to making targeted advance payments.” But those payments will need to be repaid and are only intended to make up for unpaid claims, not to cover costs associated with the fallout from the hack, like interest charges associated with taking out loans.

“There’s been no effort to talk about how to relieve us from those costs,” Hilliard said.

Unpaid claims

Providers have also said while they appreciate the assistance, the amount being offered is small compared with how much they are experiencing in unpaid claims.

Hilliard said UnitedHealth Group has offered money, and while it came quickly, it is less than 10% of what is being held up in claims right now.

Peggy Anderson, president and CEO of Third Street Family Health Services, based in Mansfield, Ohio, said revenue dropped from an average of $650,000 per week to $180,000 per week.

“That’s a pretty significant loss for us not knowing when things will be up and running again,” she said.

Third Street Family Health Services was able to get approved for $100,000 in assistance from Optum, $80,000 of which has come through so far. The center has been able to use some of its cash on hand and took out a line of credit.

“While the $100,000 is wonderful, we’re close to a million dollars now that’s just sitting there, and that’s revenue that we fully anticipated getting in,” Anderson said. She hopes policymakers recognize the need for a “safety net” system that can back up critical health care providers when emergencies like this happen in the future.

Some providers have had more luck.

Berinna Doggett, executive vice president of health care and community resources for So Others Might Eat, which has two health care clinics in Washington, D.C., said they have switched clearinghouses and received checks from Medicaid managed care plans over the past few weeks.

The problem occurs if insurers haven’t switched clearinghouses. Also, the process can move slowly.

“It’s minimal. It’s nowhere where we were,” Doggett said.

___

©2024 CQ-Roll Call, Inc., All Rights Reserved. Visit cqrollcall.com. Distributed by Tribune Content Agency, LLC.

From her base in Gallup, New Mexico, Melissa Wyaco supervises about two dozen public health nurses who crisscross the sprawling Navajo Nation searching for patients who have tested positive for or been exposed to a disease once nearly eradicated in the U.S.: syphilis.

Infection rates in this region of the Southwest — the 27,000-square-mile reservation encompasses parts of Arizona, New Mexico, and Utah — are among the nation’s highest. And they’re far worse than anything Wyaco, who is from Zuni Pueblo (about 40 miles south of Gallup) and is the nurse consultant for the Navajo Area Indian Health Service, has seen in her 30-year nursing career.

Syphilis infections nationwide have climbed rapidly in recent years, reaching a 70-year high in 2022, according to the most recent data from the Centers for Disease Control and Prevention. That rise comes amid a shortage of penicillin, the most effective treatment. Simultaneously, congenital syphilis — syphilis passed from a pregnant person to a baby — has similarly spun out of control. Untreated, congenital syphilis can cause bone deformities, severe anemia, jaundice, meningitis, and even death. In 2022, the CDC recorded 231 stillbirths and 51 infant deaths caused by syphilis, out of 3,761 congenital syphilis cases reported that year.

And while infections have risen across the U.S., no demographic has been hit harder than Native Americans. The CDC data released in January shows that the rate of congenital syphilis among American Indians and Alaska Natives was triple the rate for African Americans and nearly 12 times the rate for white babies in 2022.

“This is a disease we thought we were going to eradicate not that long ago, because we have a treatment that works really well,” said Meghan Curry O’Connell, a member of the Cherokee Nation and chief public health officer at the Great Plains Tribal Leaders’ Health Board, who is based in South Dakota.

Instead, the rate of congenital syphilis infections among Native Americans (644.7 cases per 100,000 people in 2022) is now comparable to the rate for the entire U.S. population in 1941 (651.1) — before doctors began using penicillin to cure syphilis. (The rate fell to 6.6 nationally in 1983.)

O’Connell said that’s why the Great Plains Tribal Leaders’ Health Board and tribal leaders from North Dakota, South Dakota, Nebraska, and Iowa have asked federal Health and Human Services Secretary Xavier Becerra to declare a public health emergency in their states. A declaration would expand staffing, funding, and access to contact tracing data across their region.

“Syphilis is deadly to babies. It’s highly infectious, and it causes very severe outcomes,” O’Connell said. “We need to have people doing boots-on-the-ground work” right now.

In 2022, New Mexico reported the highest rate of congenital syphilis among states. Primary and secondary syphilis infections, which are not passed to infants, were highest in South Dakota, which had the second-highest rate of congenital syphilis in 2022. In 2021, the most recent year for which demographic data is available, South Dakota had the second-worst rate nationwide (after the District of Columbia) — and numbers were highest among the state’s large Native population.

In an October news release, the New Mexico Department of Health noted that the state had “reported a 660% increase in cases of congenital syphilis over the past five years.” A year earlier, in 2017, New Mexico reported only one case — but by 2020, that number had risen to 43, then to 76 in 2022.

Starting in 2020, the covid-19 pandemic made things worse. “Public health across the country got almost 95% diverted to doing covid care,” said Jonathan Iralu, the Indian Health Service chief clinical consultant for infectious diseases, who is based at the Gallup Indian Medical Center. “This was a really hard-hit area.”

At one point early in the pandemic, the Navajo Nation reported the highest covid rate in the U.S. Iralu suspects patients with syphilis symptoms may have avoided seeing a doctor for fear of catching covid. That said, he doesn’t think it’s fair to blame the pandemic for the high rates of syphilis, or the high rates of women passing infections to their babies during pregnancy, that continue four years later.

Native Americans are more likely to live in rural areas, far from hospital obstetric units, than any other racial or ethnic group. As a result, many do not receive prenatal care until later in pregnancy, if at all. That often means providers cannot test and treat patients for syphilis before delivery.

In New Mexico, 23% of patients did not receive prenatal care until the fifth month of pregnancy or later, or received fewer than half the appropriate number of visits for the infant’s gestational age in 2023 (the national average is less than 16%).

Inadequate prenatal care is especially risky for Native Americans, who have a greater chance than other ethnic groups of passing on a syphilis infection if they become pregnant. That’s because, among Native communities, syphilis infections are just as common in women as in men. In every other ethnic group, men are at least twice as likely to contract syphilis, largely because men who have sex with men are more susceptible to infection. O’Connell said it’s not clear why women in Native communities are disproportionately affected by syphilis.

“The Navajo Nation is a maternal health desert,” said Amanda Singer, a Diné (Navajo) doula and lactation counselor in Arizona who is also executive director of the Navajo Breastfeeding Coalition/Diné Doula Collective. On some parts of the reservation, patients have to drive more than 100 miles to reach obstetric services. “There’s a really high number of pregnant women who don’t get prenatal care throughout the whole pregnancy.”

She said that’s due not only to a lack of services but also to a mistrust of health care providers who don’t understand Native culture. Some also worry that providers might report patients who use illicit substances during their pregnancies to the police or child welfare. But it’s also because of a shrinking network of facilities: Two of the Navajo area’s labor and delivery wards have closed in the past decade. According to a recent report, more than half of U.S. rural hospitals no longer offer labor and delivery services.

Singer and the other doulas in her network believe New Mexico and Arizona could combat the syphilis epidemic by expanding access to prenatal care in rural Indigenous communities. Singer imagines a system in which midwives, doulas, and lactation counselors are able to travel to families and offer prenatal care “in their own home.”

O’Connell added that data-sharing arrangements between tribes and state, federal, and IHS offices vary widely across the country, but have posed an additional challenge to tackling the epidemic in some Native communities, including her own. Her Tribal Epidemiology Center is fighting to access South Dakota’s state data.

In the Navajo Nation and surrounding area, Iralu said, IHS infectious disease doctors meet with tribal officials every month, and he recommends that all IHS service areas have regular meetings of state, tribal, and IHS providers and public health nurses to ensure every pregnant person in those areas has been tested and treated.

IHS now recommends all patients be tested for syphilis yearly, and tests pregnant patients three times. It also expanded rapid and express testing and started offering DoxyPEP, an antibiotic that transgender women and men who have sex with men can take up to 72 hours after sex and that has been shown to reduce syphilis transmission by 87%. But perhaps the most significant change IHS has made is offering testing and treatment in the field.

Today, the public health nurses Wyaco supervises can test and treat patients for syphilis at home — something she couldn’t do when she was one of them just three years ago.

“Why not bring the penicillin to the patient instead of trying to drag the patient in to the penicillin?” said Iralu.

It’s not a tactic IHS uses for every patient, but it’s been effective in treating those who might pass an infection on to a partner or baby.

Iralu expects to see an expansion in street medicine in urban areas and van outreach in rural areas, in coming years, bringing more testing to communities — as well as an effort to put tests in patients’ hands through vending machines and the mail.

“This is a radical departure from our past,” he said. “But I think that’s the wave of the future.”

___

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

WASHINGTON (AP) — U.S. Supreme Court justices on Tuesday did not appear ready to limit Americans’ access to the abortion pill mifepristone, in a case that could have major implications for the Food and Drug Administration’s oversight of thousands of medications.

It’s the first abortion-related case the court has taken since a majority of the current justices struck down the constitutional right to abortion in 2022.

A group of anti-abortion doctors had asked the court to restrict access to mifepristone and to limit when in a pregnancy it could be used.

Key moments from the arguments:

ABORTION PILL SAFETY UNDER MICROSCOPE

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. Last year it was used in more than six in 10 of the abortions in the U.S.

The central argument of the conservative group challenging mifepristone is that the Food and Drug Administration overlooked serious problems with the drug when it eased restrictions on the drug, including making it available via mail in 2021.

Erin Hawley, who represented the doctors and group suing the agency, argued the FDA “failed to consider or explain … its wholesale removal of safeguards” on the pill.

But the FDA has long argued its decision to drop in-person appointments to get mifepristone, among other requirements, came after 20 years of monitoring its safety. In that period the agency reviewed dozens of studies in thousands of women in which serious problems — including hospitalization — occurred less than 0.3% of the time.

Hawley pointed out that FDA’s own prescribing label mentions that 2.9% to 4.6% of women taking the drug go to the emergency room. But Solicitor General Elizabeth Prelogar pointed to studies showing that half of women who go to the emergency room don’t get any treatment at all.

“Many women might go because they’re experiencing heavy bleeding, which mimics a miscarriage, and they might just need to know whether or not they’re having a complication, ” Prelogar said.

Because of the highly technical nature of reviewing drugs, courts have long deferred to FDA’s scientific judgements on drug safety and effectiveness.

Justice Ketanji Brown Jackson pressed Hawley on the consequences of second-guessing the agency’s regulators.

“So what deference do we owe them at all with respect to their assessment that these studies establish what it is that they say they do about safety and efficacy?”

HOW FAR TO GO

Hawley ran into questions as she argued that a nationwide rule curtailing mifepristone use was needed.

She was repeatedly interrupted by Justice Neil Gorsuch, who voiced objections to such sweeping injunctions.

The case “seems like a prime example of turning what could be a small lawsuit into a nationwide legislative assembly on an FDA rule or any other federal government action,” said Gorsuch.

Normally when a court issues an injunction about a government policy it only applies to the individuals or groups in the case. But in recent years a growing number of justices on lower courts have issued “universal injunctions,” blocking federal regulations.

Gorsuch noted that there have been roughly 60 such rulings in the last four years.

Chief Justice John Roberts also seemed skeptical that a ruling reversing the FDA’s scientific judgments was necessary.

“Why can’t the court specify that this relief runs to precisely the parties before the court as opposed to looking to the agency in general and saying, ‘Agency, you can’t do this anywhere?’”

RIGHT TO SUE

The Biden administration argued that the plaintiffs — a group of anti-abortion doctors — didn’t have the right to challenge the FDA’s approval of mifepristone.

The doctors who brought the suit argued that they might have to treat emergency room patients who experience serious complications from mifepristone.

But Solicitor General Elizabeth Prelogar told the court that the doctors don’t have to prescribe mifepristone and they can abstain from treating patients who have taken the pill if they oppose abortion.

“They don’t prescribe mifepristone,” Prelogar said. “They don’t take mifepristone, obviously. The FDA is not requiring them to do or refrain from doing anything. They aren’t required to treat women who take mifepristone.”

Justice Samuel Alito, however, repeatedly pressed the government on who did have the right to sue over FDA’s decisions.

“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful?” Alito, who wrote the 2022 ruling that overturned Roe v. Wade, asked.

REAL-LIFE EXAMPLES, PLEASE

Several justices pressed Hawley to provide real-life examples of doctors who oppose abortion being forced to treat patients who had suffered from abortion pill complications.

They also took issue with how many hypothetical problems Hawley raised in her argument against the FDA’s loosening of abortion pill restrictions.

“I don’t want to hypothesize,” Jackson said to Hawley, asking her to provide an example of a doctor who was unable to object to providing an abortion.

At one point, Justice Amy Coney Barrett also questioned an example one of the doctors provided of a colleague who had to perform a “dilation and curettage” procedure on a patient with complications. Barrett pointed out that those procedures are not just performed in cases of abortions but for miscarriages as well.

Some of the justices also pointed out that doctors are already protected from performing abortions when they don’t want to by voicing conscience objection.

Justice Brett Kavanaugh raised that point early on: “Under federal law, no doctors can be forced against their consciences to perform or assist in an abortion, correct?”

MORE DRUGS AT RISK

The FDA is the government agency responsible for assessing the safety of drugs and approving their sale in the United States.

It originally approved mifepristone in 2000. In 2016, FDA said it could be prescribed up to 10 weeks of pregnancy and allowed nurses and other medical professionals to prescribe. It allowed sales through the mail in 2021.

Jessica Ellsworth, an attorney representing the New York-based Danco Laboratories, which makes mifepristone, asked the justices to consider how the case could upend the country’s entire pharmaceutical regulatory structure.

“I think this court should think hard about the mischief it would invite if it allowed agencies to start taking action based on statutory responsibilities that Congress has assigned to other agencies,” she said.

U.S. District Judge Matthew Kacsmaryk’s decision last year marked the first time a court has ever ordered the agency to withdraw the approval of a drug. An open letter signed by nearly 300 biotech and pharmaceutical company leaders last year slammed the ruling as undermining Congress’ delegated authority to the FDA to approve and regulate drugs. If justices can unilaterally overturn drug approvals, they said “any medicine is at risk.”

Fernando reported from Chicago.

Hampden Superior Court Judge Edward McDonough accepted former superintendent Bennett Walsh’s plea admitting to sufficient facts to five counts of neglect of an elder related to Walsh’s decision to combine multiple dementia care units into one in March 2020, which in turn led to the deaths of numerous residents who had not been exposed to the virus before the change.

McDonough ordered the case be continued for three months without a finding and ordered Walsh to comply with probationary conditions including that Walsh not contact the victims’ families or work in a medical field. McDonough did not impose probation itself. This finding was identical to the defense’s recommendation.

The prosecution recommended that Walsh serve three years of probation with the first year under home confinement. The prosecutor said the recommendation for only probation and not any prison was made because Walsh had a clean criminal record. The maximum penalty for each count was three years in state prison.

At the same hearing, Dr. David Clinton, the the home’s former medical director, also admitted to sufficient facts in his case and received the same continued finding.

This conclusion left state Attorney General Andrea Campbell “disappointed.”

“Today the justice system failed the families who lost their loved ones at the Holyoke Soldiers’ Home,” she said in a statement. “I am disappointed and disheartened with the Court’s decision, and want these families and our veterans to know my office did everything it could to seek accountability. We will continue to be vigilant in prosecuting cases of elder abuse and neglect.”

Over the course of the roughly hour-long hearing in Hampshire Superior Court in Northampton, the prosecution and the defense painted different pictures of the crisis at the Soldiers Home.

The prosecutor said that the conditions of the consolidated dementia care unit “were quite bad” and had been described variously by those who witnessed it as “a war zone,” “a battlefield,” and “the worst I have ever seen.”

The prosecutor described the consolidated unit as overly ad hoc, and that dementia care patients were seen wandering around naked, or nearly so, and crammed so tightly that there were double the allowed number of people per room.

When the unit was first created, the prosecutor argued, five of nine residents who were assigned to live in the dining room were asymptomatic for COVID19, but the cramped conditions and lack of medical care caused them to come down with the fatal virus.

Walsh said during his change of plea that he accepted there were sufficient facts to convict him of neglect, but that he does “not admit that such a decision was wanton and reckless in light of the situation.”

Walsh and his attorney said that Walsh, a career military man, had assessed the dire staffing shortage in light of the current guidance coming from state and federal leaders in those confused, early days of COVID.

Walsh’s attorney said that in the weeks leading up to the crisis at the Soldiers Home, the flu had been bad in Massachusetts but the state had only seen one confirmed case of COVID-19. He said that leaders sent out an email basically saying that, “Yes, it is very contagious but it is also not a danger to the majority of people who catch it.”

Associated Press materials were used in this report.

We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.

President Joe Biden in his State of the Union address, March 7, 2024

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President Joe Biden has been making his case for reelection to voters by telling them he is good for their pocketbooks, including at the pharmacy counter.

During his State of the Union address, Biden said legislation he signed gave Medicare the power to negotiate lower prescription drug prices.

“That’s not just saving seniors money and taxpayers money,” Biden said, a reference to the Inflation Reduction Act, which passed in 2022. “We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.”

Biden added, “This year, Medicare is negotiating lower prices for some of the costliest drugs.” He called for giving Medicare the power to negotiate prices for 500 drugs over the next decade.

In August, the federal government announced the first 10 drugs that it will negotiate for lower prices as part of the Inflation Reduction Act. A respected source of legislation analysis projects the change will save the government a lot of money, but those dollars haven’t been realized.

There is a reason Biden touted this legislation during his address: Polling by KFF shows that people, regardless of their political leanings, overwhelmingly support the idea of allowing Medicare to negotiate drug prices. But most people don’t know that such negotiations are underway.

Impact of Inflation Reduction Act Will Take Many Years

In August 2022, Biden signed the Inflation Reduction Act, which will allow the federal government to negotiate prices with drugmakers for Medicare. Biden kept his promise to repeal the law that barred Medicare from negotiating prices.

The nonpartisan Congressional Budget Office projects a 10-year cumulative savings of $161.7 billion from two provisions of the Iaw: a phased-in effort to negotiate with drugmakers for lower prices and a rebate for price increases above the overall inflation rate. (The White House has previously pointed to this analysis.)

However, not all the savings will be permanent. About $44.3 billion over 10 years will be funneled into related provisions that expand access and lower out-of-pocket costs for Medicare beneficiaries.

“Negotiations are still ramping up, so the savings generated by the Inflation Reduction Act negotiation provisions are still in the future,” said Matthew Fiedler, a Brookings Institution expert on the economy and health studies. “The Congressional Budget Office did expect the inflation rebate provisions of the IRA (which are encompassed in the $160 billion) to begin generating modest savings during 2023 and 2024, but there, too, most of the savings are in the future.”

The legislation involves price negotiations for 10 brand-name medications that lack generic equivalents. Those drugs include the blood thinners Eliquis and Xarelto; the diabetes drugs Januvia, Jardiance, and NovoLog; Enbrel, for rheumatoid arthritis; the blood-cancer drug Imbruvica; Entresto, for heart failure; Stelara, for psoriasis and Crohn’s disease; and Farxiga, a drug for diabetes, heart failure, and chronic kidney disease.

The CBO has estimated that the negotiated prices will translate to nearly $100 billion in federal savings from 2026 to 2031.

“Biden is jumping the gun on claiming savings for seniors,” said Joe Antos, an expert on health care at the conservative American Enterprise Institute. “Price negotiations haven’t been completed; the new prices for selected drugs aren’t in place until 2026.”

Biden said the legislation is “saving seniors money and taxpayers money,” which could be interpreted to mean it is saving them money now on prescription drugs. But the negotiations for these drugs would define the prices to be paid for prescriptions starting in 2026. For 2027 and 2028, 15 more drugs per year will be chosen for price negotiations. Starting in 2029, 20 more will be chosen a year.

That said, other provisions in the legislation have already led to savings for seniors, said Tricia Neuman, a senior vice president at KFF:

• Certain recommended adult vaccines covered under Medicare Part D, such as shingles, are covered at no cost.
• The act established a cap on Part D spending that begins phasing in this year. This year, Part D enrollees will pay no more than $3,300 on brand-name drugs. In 2025, the cap for all covered Part D drugs drops to $2,000.
• The Inflation Reduction Act included the $35-a-month insulin cap, improvements in coverage for low-income beneficiaries, and the inflation rebate.

When we pressed the White House to provide examples of savings that have already occurred, a spokesperson pointed to the insulin cap.

Meanwhile, Antos said that although the Part D rebate has kicked in, the savings come from a small subset of Part D drugs taken by older Americans and that the government reaps the savings, not older Americans.

“There is no reason to expect that seniors will see significant savings since there’s no obligation for the feds to distribute savings to Part D enrollees,” Antos said.

Our Ruling

Biden said, “We cut the federal deficit by $160 billion because Medicare will no longer have to pay those exorbitant prices to Big Pharma.”

Biden’s statement omits the time frame; the savings have not been realized. The CBO projected 10-year cumulative savings of $161.7 billion from two provisions of the legislation. And as for saving older Americans money on their prescriptions, that hasn’t happened yet. The federal government is negotiating the first 10 drugs with the new prices set to take effect in 2026.

We rate this statement Half True.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

In early 2019, Jennifer Hepworth and her husband were stunned by a large bill they unexpectedly received for their daughter’s prescription cystic fibrosis medication. Their payment had risen to $3,500 from the usual $30 for a month’s supply.

That must be a mistake, she told the pharmacy. But it wasn’t. It turned out that the health insurance plan through her husband’s job had a new program in which it stopped applying any financial assistance they received from drugmakers to the family’s annual deductible.

Insurers or employers can tap into funds provided to patients by drugmakers through copay assistance programs, which were designed by the companies to help patients afford increasingly expensive medications. But, because those payments are no longer counted toward the deductible, patients must pay an amount out-of-pocket, too, often for the same drugs. Those deductibles or other out-of-pocket costs can easily run into thousands of dollars.

Here’s what that meant for Hepworth, who lives in Utah. Before the change, the drugmaker’s copay assistance would almost immediately meet her family’s deductible for the year, because both Hepworth and her daughter need expensive medications. As a result, the family was responsible for copays of only 20% of their medical costs instead of the 100% required by their plan until they met their deductible. By the middle of the year, the family would have reached the plan’s out-of-pocket maximum of nearly $10,000 and would no longer owe any copays.

Hepworth ended up paying the $3,500 to the pharmacy, equivalent to the family’s annual deductible, because she didn’t want to stop giving her daughter a treatment that could extend her life. “We were struggling and everything went on credit cards.”

Why did the insurer do this?

Employers or the health insurance plans they hire are saving 10% to 15% of the cost of prescription plan claims by using these copay accumulator programs, said Edward Kaplan, a senior vice president at Segal, a benefits consulting firm. Even so, Kaplan doesn’t recommend that his clients, who include public and private employers, take advantage of the program because of the increasing pushback from lawmakers and advocacy groups. However, the majority of insured people are in plans governed by these types of programs, according to Avalere, a consulting firm.

Nineteen states now limit copay accumulator programs for some insurance plans. And patient advocacy groups have won a favorable court ruling against the programs. States’ limits on the practice, however, do not apply to larger, self-insured job-based plans, through which many Americans have coverage.

Bipartisan legislation has been introduced in both chambers of Congress that would require financial assistance to count toward deductibles and other out-of-pocket costs. Called the Help Ensure Lower Patient Copays Act, it would govern plans that are exempt from state rules.

Change is unlikely to come soon.

Insurers and employers have long complained that copay assistance programs are mainly a marketing ploy by the drug industry that encourages patients to stay on costly drugs when lower-cost alternatives might be available. Insurers say capturing more of that money themselves can help slow the rising price of premiums.

In a recent letter to regulators, the Blue Cross Blue Shield Association called the practice “a vital tool in keeping health insurance affordable.”

Patient advocacy groups, including the HIV+Hepatitis Policy Institute and two diabetes groups, disagreed and took a case against copay accumulator programs to U.S. District Court last fall.

And “we won,” said Carl Schmid, executive director of the institute. The groups argued the practice can cause some patients to skip their medications because of the unexpected costs they must now shoulder.

Some critics say it’s a form of double dipping because even though the patient hasn’t personally paid out-of-pocket, “that payment was made, and it was made on your behalf. I think that should get counted,” said Rachel Klein, deputy executive director with the AIDS Institute, an advocacy group.

The court decision, Schmid said, essentially overturns a 2021 provision in Centers for Medicare & Medicaid Services rules that allowed insurers to expand the practice to cover almost any drug. Previous rules from 2020 would now be in effect, said Schmid, and those rules say copay assistance should count toward the deductible for all drugs for which there is no medically appropriate generic alternative available.

Even so, billing changes for many insured patients may take a while.

While the Biden administration dropped an appeal of the court decision, it has filed motions noting “it does not intend to take any enforcement action against issuers or plans” until regulators draw up new rules, said Ellen Montz, deputy administrator and director of the Center for Consumer Information and Insurance Oversight at CMS, in a written statement to KFF Health News.

A version of these programs being used by insurers, sometimes called a “maximizer,” works a bit differently.

Under a maximizer program, insurers partner with outside firms such as PrudentRX and SaveOnSP. The programs declare certain drugs or classes of drugs “nonessential,” thus allowing them to circumvent some Affordable Care Act rules that limit patient cost sharing. That lets the insurer collect the maximum amount from a drugmaker’s assistance program, even if that is more than the patient would owe through deductibles or out-of-pocket maximums had the drugs remained essential benefits. These partner companies also work with large pharmacy benefit managers that oversee prescription services for employers.

Those maximizer payments do not count toward a patient’s deductible. Many insurers don’t charge patients an additional copay for the drugs deemed nonessential as a way of enticing them to sign up for the programs. If patients choose not to enroll, they could face a copayment far higher than usual because of the “nonessential” designation.

“This is a loophole in the ACA that they are exploiting,” said Schmid of the HIV+Hepatitis Policy Institute, referring to the Affordable Care Act. Johnson & Johnson filed a lawsuit in federal court in New Jersey in 2022 against such a maximizer program, saying it coerced patients into participating because if they didn’t they faced higher copays. The drugmaker warned it might reduce the amount of overall assistance available to patients because of the increasingly common practice.

Now, though, a provision in the proposed 2025 federal rules governing health insurers says plans must consider any covered drug an “essential benefit.” If finalized, the provision would hamper insurers’ ability to collect the maximum amount of drugmaker assistance.

Employers are watching for the outcome of the lawsuit and the proposed federal rules and don’t yet have clarity on how rulings or regulations will affect their programs, said James Gelfand, president and chief executive of the ERISA Industry Committee, which advocates for large, self-insured employers.

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

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.

The Supreme Court’s anti-abortion majority is set to consider whether to order a reversal in U.S. drug laws and restrict women from obtaining abortion medication at pharmacies or through the mail.

A ruling to restrict the most common method of abortion would limit the rights of women in California and other states where abortion remains legal.

“We may have thought we were protected because California is supportive of abortion, but this decision [on abortion pills] will be national in scope,” said Dr. Daniel Grossman, a professor of obstetrics at UC San Francisco.

The case is the most significant abortion question to come before the court since it overturned the constitutional right to abortion.

In that Dobbs ruling two years ago, the 5-4 majority sought to reassure those who live in states where abortion remains protected. Judges should not make the rules on abortion, they said, promising to return “that authority to the people and their elected representatives.”

But that pledge faces a major test. Conservative judges in Texas have shown themselves very willing to rewrite the rules for abortion medication and to impose their rules in blue states.

Whether they prevail now depends on the three conservative justices appointed by President Trump who were crucial to overturning Roe vs. Wade: Justices Neil M. Gorsuch, Brett M. Kavanaugh and Amy Coney Barrett. If all three join with Justices Clarence Thomas and Samuel A. Alito, they could roll back the use of abortion pills.

“It could eliminate telemedicine and reimpose the in-person dispensing requirement,” Grossman said. “It could also set a very bad precedent for the FDA.”

Several years after the drug mifepristone had been legalized in much of Europe, the Food and Drug Administration in 2000 approved its use as a safe and effective means of ending an early pregnancy. Since 2016, the agency has liberalized its regulations to permit patients to consult a doctor through telemedicine and to obtain the pills without traveling to a clinic. It is now part of a two-drug combination accounting for more than half of U.S. abortions.

When taken in combination with misoprostol, the pills cause cramping and some bleeding. It can sometimes require a doctor’s intervention to complete the abortion, but the FDA says serious complications are “exceedingly rare,” noting that more than 5 million women in the U.S. have used the medication since 2000.

More than a dozen major medical groups, led by the American College of Obstetricians & Gynecologists and the American Medical Assn., said in friend-of-the court briefs that two decades of studies have shown the drugs are safe.

“When used in medication abortion, major adverse events — significant infection, excessive blood loss or hospitalization — occur in less than .32% of patients,” they wrote.

On Tuesday, however, the court will hear a broad attack on the FDA from attorney Erin M. Hawley, the wife of Republican Missouri Sen. Josh Hawley and a former law clerk to Chief Justice John G. Roberts. She says the court should not turn “a blind eye to FDA’s patently unreasonable actions here, which jeopardize women’s health throughout the nation.”

Hawley is not representing women who say they were injured by the drugs or doctors who prescribe the medication. Instead, she is representing a group of doctors who oppose abortion on religious and moral grounds.

She argues they have legal standing to sue the FDA because some of the group’s members work in emergency rooms, and they could be forced to treat patients who took abortion pills and went to a hospital because of bleeding or other complications.

“When faced with these emergencies, [the doctors] have no choice but to provide immediate treatment, even though this kind of participation in an elective abortion harms their consciences and injures them in other ways,” Hawley wrote in her brief to the court.

Shortly after the Supreme Court repealed the right to abortion in the Dobbs case, Hawley filed a lawsuit in Amarillo, Texas, seeking the repeal of the FDA’s approval of mifepristone.

The location was no accident. Her suit would come before U.S. District Judge Matthew Kacsmaryk, a Trump appointee who has been an outspoken foe of same-sex marriage and LGBTQ+ rights. Kacsmaryk had served as deputy general counsel for First Liberty Institute, a Christian conservative nonprofit that works on religious freedom cases, and had criticized the Supreme Court’s landmark 1973 Roe vs. Wade decision before its reversal.

In past decades, conservatives often railed against “judicial activism” and judges who “legislate from the bench.” In recent years, however, conservative activists have gone before judges in red states seeking to win major changes in the law that they could not win from Congress or the White House.

As predicted, Kacsmaryk handed down a broad ruling against what he called “chemical abortion” and ordered the FDA “to suspend” its approval of the drugs. In a ruling using language common to anti-abortion groups, Kacsmaryk said the studies submitted by the FDA did not convince him mifepristone was safe.

The government rushed to appeal last April, and the U.S. Court of Appeals for the 5th Circuit agreed to limit Kacsmaryk’s ruling. By a 2-1 vote, the appeals court said it was too late to unravel the approval of the drug in 2000, but not too late to overturn the FDA’s regulations that since 2016 have made it easier for women to obtain the pills.

Biden administration Solicitor Gen. Elizabeth B. Prelogar called the case a first.

She said it “marks the first time any court has restricted access to an FDA-approved drug by second-guessing FDA’s expert judgment about the conditions required to assure that drug’s safe use.”

She urged the Supreme Court to put the lower court rulings on hold, and the justices did so over dissents by Thomas and Alito. A few months later, the court agreed to rule in the case of FDA vs. Alliance for Hippocratic Medicine.

Abortion-rights advocates are troubled the case has gotten so far.

“This makes a mockery of our legal system,” said Julia Kaye, an attorney for the American Civil Liberties Union. “This is a group of anti-abortion extremists going before a hand-picked judge and using junk science and sham claims about women’s health to serve their true goal of making abortion inaccessible.”

The solicitor general, representing the FDA, will urge the court to end the case quietly by throwing out the lawsuit.

Usually, the court has said plaintiffs have standing to sue over a law or regulation only if they are or will be personally injured by it.

The anti-abortion doctors who sued “do not prescribe mifepristone, and FDA’s actions allowing other providers to prescribe the drug do not require them to do or refrain from doing anything,” Prelogar wrote in her brief to the court. They “have not identified even a single doctor among their thousands of members who has ever been required to perform an abortion in the decades mifepristone has been on the market.”

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©2024 Los Angeles Times. Visit at latimes.com. Distributed by Tribune Content Agency, LLC.

To understand the 2024 U.S. presidential election, it is essential to understand the politics of fentanyl.

Americans have been traumatized by a years-long wave of overdose deaths caused by the synthetic opioid. Once rarely used outside hospitals, fentanyl has become a ubiquitous street drug made by criminal gangs, often in Mexico, from cheap chemicals typically manufactured in China. It frequently is a hidden ingredient in other illicit drugs and can have fatal consequences for unsuspecting users.

Ending the scourge, voters indicate, is a high priority.

About 8 in 10 voters in seven swing states say fentanyl misuse is a “very important” or “somewhat important” issue when deciding who to vote for in November — more than the number who cite abortion, climate change, labor and unions, or the wars in Ukraine and Gaza, according to a recent Bloomberg News/Morning Consult poll of almost 5,000 registered voters.

Fentanyl has come up repeatedly in a campaign unfolding after an especially deadly phase in the U.S. opioid epidemic. From just before the start of the COVID-19 pandemic in November 2019 to October 2023, about 270,000 people died of an overdose from a synthetic opioid, according to the most recent provisional data from the Centers for Disease Control and Prevention. Those fatalities account for the vast majority of overall opioid overdose deaths, which have climbed to about 80,000 a year.

The crisis has received increasing attention on cable news, is the target of scores of bills in Congress and has become a rallying cry from statehouses to school-board meetings across the country. And while ideas range from ramping up treatment options to waging war on cartels, voters appear united by a desire to break fentanyl’s grip on American society.

Presidential candidates are seizing on the issue to firm up support from party faithful and woo voters whose allegiances may have shifted due to the crisis. For President Joe Biden, a Democrat, and former President Donald Trump, the presumptive Republican nominee, fentanyl is also a way to talk about everything from immigration and border security to China and crime.

Early in his term, Biden made addressing the epidemic the first pillar of his “Unity Agenda” intended to bring Democrats and Republicans together. Yet during this year’s State of the Union address, a gap was on display, as Biden chastised GOP lawmakers for not taking a harder stance. “Strengthen penalties on fentanyl trafficking — you don’t want to do that, huh?” he said.

For his part, Trump has blamed Biden’s immigration policies for the rise in overdoses. He has called for deploying the U.S. military to Mexico and for using the death penalty as a punishment for drug smugglers.

“Our country is being poisoned from within by the drugs and by all of the other crime that’s taking place,” he has said. A Republican National Committee spokesperson said Trump would “make America safe again” if reelected.

Registered voters were most likely to hold U.S. drug users and Mexican cartels responsible for the epidemic, according to the Bloomberg/Morning Consult poll. Voters from both parties agree the U.S. should work with Mexico and Canada to combat drug trafficking.

Drug-overdose deaths broadly are a problem across the U.S., with recent surges in places like Alaska, Washington state and Alabama. More than 4 in 10 Americans personally know someone who has died from a drug overdose, according to a study by the nonprofit Rand Corp.

Just 2 milligrams of fentanyl, equivalent to 10 to 15 grains of table salt, is considered a lethal dose. Traffickers tend to distribute it by the kilogram, which is enough to kill 500,000 people, according to the Drug Enforcement Administration. The drug’s street value varies — one pill can cost less than a dollar, while a pound of powder can cost well more than $10,000.

Since Biden took office, the U.S. has seized more than 100 million pounds of fentanyl and 150 million fentanyl-laced pills, according to data from the DEA and the Department of Homeland Security. The White House said it has denied drug traffickers billions of dollars in profits.

In Arizona — a swing state along the Mexico border that has seen a recent rise in synthetic opioid overdose deaths — fentanyl’s intersection with U.S. political divisions is plain to see. Emergency medical services in Tempe, home to Arizona State University, receive roughly two calls a day, on average, related to opioids. Wastewater surveillance shows pervasive fentanyl use in the city of roughly 186,000 people just east of Phoenix. Last year, local law enforcement said they helped seize 4.5 million fentanyl-laced pills and 140 pounds of fentanyl powder that federal officials said was being distributed by the Sinaloa drug cartel.

“We used to deal with traditional drugs and traditional crises,” said Sergeant Rob Ferraro, a Tempe police officer who helped set up a program that trains cops on administering overdose antidote naloxone. In the past four years, city police have saved 330 lives with the therapy, and helped get half into treatment through a partnership with a local health organization, according to Ferraro. Yet the success of such efforts hasn’t always resonated with voters, he said.

“There are different beliefs about how fentanyl is getting here. People blame Trump, they blame Biden,” Ferraro said. “It’s no different from anything else in our country: It’s very polarizing, very binary.”

About one-third of swing-state voters trust neither Biden nor Trump to handle the crisis, according to the Bloomberg News/Morning Consult poll, which has a margin of error of one percentage point.

Some people who have been directly affected by the crisis say that neither candidate did enough to get fentanyl under control during their time in the White House.

“It’s becoming an issue in the election because it’s been ignored by both administrations,” said Jim Rauh of Akron, Ohio, who lost his 37-year-old son to fentanyl in 2015 and now runs an advocacy group called Families Against Fentanyl.

“The Trump administration ignored it, the Biden administration is now turning a blind eye,” said Rauh. “They’ve both evaded their duties.”

The Biden reelection campaign said the two administrations have taken drastically different approaches to navigating the epidemic.

“Trump was all talk and no action on the opioid crisis, declaring an emergency and then failing to allocate additional resources or even to develop a national opioid strategy as required by law,” said spokesperson Lauren Hitt. Meanwhile, the Biden administration has focused on solutions that are popular among both Democrats and Republicans, she said.

Democrats were more likely than Republicans to want to see the U.S. make overdose antidotes more available and provide treatment for opioid-use disorder. Republicans, meanwhile, wanted in greater numbers to increase security at the U.S.-Mexico border and limit migration, the Bloomberg/Morning Consult poll found. Harm-reduction strategies such as needle exchanges and efforts to decriminalize recreational fentanyl use were broadly unpopular with voters overall.

Progressive cities like Portland, Oregon, and San Francisco have seen a backlash against relaxed drug laws. Oregon’s Democratic governor, Tina Kotek, has said she will sign a bill to make possession of illicit drugs a crime again, while in San Francisco, voters backed a measure sponsored by Democratic Mayor London Breed that would make welfare recipients suspected of using drugs undergo screening and enroll in a treatment program.

Mentions of fentanyl on three major cable news networks began rising in 2021 and peaked in March 2023, when the networks referred to fentanyl in about 1,900 15-second clips, according to closed-captioning data from the Internet Archive’s TV News archive. Fox News referred to fentanyl about three times as often as CNN in March 2023, and about 13 times more than MSNBC, according to the Internet Archive, a nonprofit that maintains a digital library of web pages, books, videos and software.

U.S. Google search interest for the term fentanyl, meanwhile, has generally surpassed interest for its broader class of drugs, opioids, since early 2022 and hit an all-time high in September of that year, according to data from Google Trends.

“It’s a bigger issue than you might think,” said Chris Ager, chairman of the New Hampshire Republican Party, a few days before the state’s primary election in January. “Even though we’re thousands of miles away from the southern border, where it’s coming from, everybody in New Hampshire, I believe, knows someone who’s been impacted by a fentanyl overdose.”

Congress has also been paying greater attention to fentanyl. Lawmakers in the House and Senate introduced more than twice as many bills and resolutions that mentioned fentanyl in 2023 than a year earlier.

State legislatures meanwhile introduced more than 600 bills about fentanyl in 2023 and enacted at least 103 laws, according to a report by the National Conference of State Legislatures.

Partisan wrangling over how to address fentanyl worries some drug-policy experts, as well as immigration advocates and local officials.

“When I started working on this issue, it wasn’t as politicized as it is today,” said Regina LaBelle, director of the Addiction and Public Policy Initiative at the O’Neill Institute at Georgetown University, who helped lead opioid strategy in the Biden and Obama administrations. It can be hard to get voters excited about public-health measures like prevention and treatment, she said.

“It’s simpler in a sound bite to say ‘China’s killing our people’ or ‘it’s immigrants coming across the border,’” she said.

Fatima Saidi, the national campaign director for We Are All America, which advocates for immigrant and refugee rights, said politicians are conflating criminals with people seeking safety. “When you’re angry, you need something to punch — and it’s the most vulnerable who are taking the punching,” she said. “Immigrants and refugees at the border should not be their punching bags.”

Seeing politicians use fentanyl to push border control isn’t surprising to Lane Santa Cruz, a Democrat on the Tucson, Arizona, City Council. “We see that time and time again with the war on drugs and the oversimplification of how drugs get to the U.S.,” she said.

Cruz ran for office in part because after she lost her brother to a fentanyl overdose in 2016, she wanted to protect young people in her community. She considers casting fentanyl as a border issue a fear tactic. “Blaming things on the border doesn’t address the root cause of why demand for drugs exists,” she said.

In an interview steps from the White House’s West Wing, Rahul Gupta, the director of National Drug Control Policy, said Biden is focused equally on stopping traffickers and treating addiction. Those are “two sides of the same coin,” Gupta said.

The death toll from the opioid crisis has been slowing but remains near all-time highs. Reported opioid overdose fatalities were down about 2.3% in the 12 months through October, according to provisional data from the CDC, and deaths from synthetic opioids like fentanyl, a subset of opioid-related deaths, were down about 0.3%.

The administration continues to push to make naloxone more accessible, Gupta said, and has taken steps to ensure people with opioid-use disorder can continue to get treatment from home, as they were throughout the pandemic. The opioid epidemic, Gupta said, “is like a large ship. We’ve been able to slow it down and stop it. We have to now turn it around.”

The U.S. is targeting accountants, real-estate agents, wealth managers and lawyers that enable the drug trade, Gupta added. The administration also wants to ramp up searches of vehicles crossing into the U.S. Some 90% of all interdicted fentanyl is stopped at these ports of entry, primarily in vehicles driven by U.S. citizens, according to the Department of Homeland Security. Gupta said it is difficult for officials to catch because fentanyl, which is 50 times more potent than heroin, is often moved in small quantities.

Biden has blamed Trump for encouraging conservative lawmakers to hold up a bipartisan border-security bill that would install 100 inspection machines at the Southwest border and strengthen U.S. authority to sanction foreigners involved in fentanyl trafficking.

“This bill would save lives and bring order to the border,” Biden said in this year’s State of the Union speech.

Still, some voters in his own party are skeptical of Biden when it comes to handling the challenges posed by fentanyl. About six in 10 Democrats in swing states said they trust him more than Trump to navigate the crisis, according to the Bloomberg/Morning Consult poll.

Among swing states surveyed, at least two — Nevada and Arizona — recorded an increase in overdoses from synthetic opioids in the 12-month period through October, according to the CDC, a sign that fentanyl is likely to remain a pivotal issue for voters until Election Day.

Eight in 10 voters in Arizona see fentanyl as a very important or somewhat important issue when deciding who to vote for later this year, according to the Bloomberg/Morning Consult poll. They were more likely to blame U.S. drug users and Mexican drug cartels for the crisis than any other entity. More said working with Mexico and Canada to combat drug trafficking or targeting foreign synthetic drug suppliers would be effective than said so about public-health measures.

Near the outset of the pandemic, Theresa Guerrero of Tucson, lost her 31-year-old son, Jacob, to a fentanyl overdose. At first, Guerrero didn’t want family or friends to know how he died.

Soon, however, Guerrero said she realized that the problem was only getting worse, and threw herself into raising awareness about fentanyl. She recently appeared in a video about the drug’s toll on families for Pinal County Sheriff Mark Lamb, who is seeking a U.S. Senate seat by promising to bolster border security — an issue Guerrero said wasn’t important to her before Jacob died.

“We are a superhighway in Arizona, with a crazy amount of pills coming through,” she said. “Our kids are not overdosing. They’re being poisoned.”

With assistance from Nancy Cook and Allan James Vestal.

©2024 Bloomberg News. Visit at bloomberg.com. Distributed by Tribune Content Agency, LLC.

Researchers at the Fred Hutchinson Cancer Center have unveiled a new type of blood test used to detect colorectal cancer, with high hopes not only in its ability to reduce barriers to testing for this particular disease, but also potentially pave the way for many other types of cancer screenings.

The study, published last week in the New England Journal of Medicine, analyzed results from nearly 8,000 people throughout the country between ages 45 and 84 and compared results of their blood tests to those of a colonoscopy. In all, the new test accurately detected colorectal cancer 83% of the time, which is “at least equal and maybe better than” a commonly used stool-based detection test, said Dr. William Grady, medical director of Fred Hutch’s gastrointestinal cancer prevention program and who led the study.

“We have a lot of people who are dying from a preventable cancer,” Grady said. “And the reason is they’re not doing colon cancer screenings. This is a real opportunity to improve that and prevent those deaths. That’s why I get excited about it.”

Colorectal cancer is the third-most diagnosed cancer and second-leading cause of cancer-related deaths among adults in the U.S., according to the paper. About 53,000 people are expected to die from the disease this year. Colorectal cancer is also increasingly being detected in younger people, with 20% of 2019 diagnoses in patients under 55 — almost double the rate reported in 1995, according to the American Cancer Society.

The trend prompted the U.S. Preventive Services Task Force, which regulates and makes recommendations when to complete certain screenings, in 2021 to lower the age to begin colon cancer testing to 45, five years earlier than previously recommended.

While researchers are still trying to understand what’s driving the change, higher obesity rates, more sedentary lifestyles and diets that include more processed foods are likely contributors, Grady said.

But early detection can significantly increase survival rates — jumping from 14% among those with metastatic cancer to a five-year survival rate of about 91% among those diagnosed at early stages, according to the Guardant Health-funded study. Still, just 59% of those eligible for screenings get tested.

“I think this is an enormous breakthrough,” said Dr. Rachel Issaka, a Fred Hutch gastroenterologist and colorectal cancer researcher who co-authored the paper. “We have another tool in our arsenal that allows people to have a noninvasive and easy way to potentially complete colon cancer screening.”

She noted the new test does not replace the colonoscopy, which identifies and removes precancerous lesions, and remains the “gold standard” for colon cancer screenings and prevention. But because the more involved procedure isn’t always easily accessible to everyone, especially communities of color and lower-income populations, Issaka is optimistic the new option can help boost screening rates and, ultimately, lower deaths.

Because blood tests are generally more convenient, relatively painless and have minimal risk involved, cancer researchers, including Grady, have considered it for decades as a tool in cancer detection, he said. Testing and analysis techniques, however, weren’t ever sophisticated enough to make it a realistic option, Grady said.

Then two “really big breakthroughs” came along, he said.

The first had to do with scientists’ ability to extract tumor cells’ DNA from the blood and process it, which has been developed and optimized over the last decade.

The second milestone involved “next-generation sequencing,” or analyzing DNA in ways that were sensitive enough to detect the rare tumor DNA present in the blood, Grady said. This sequencing has “rapidly advanced over the last 20-plus years,” including in ways to identify potential biomarkers, he added.

Next-generation sequencing hasn’t yet been widely used in cancer detection tests, but Grady’s excitement about the possibilities was evident.

“I think this [colon cancer] test is going to usher in a wave of other types of screening tests,” he said, pointing to ongoing clinical trials that screen people at risk for lung cancer and research around breast cancer blood tests. “Could you replace mammograms with this? I’m going to guess those types of studies will be coming out in the next few years.”

Despite enthusiasm around new technologies — including artificial intelligence’s role in more efficient data analysis — Issaka stressed an importance to pay attention to how these and future tests are rolled out in clinical spaces. It’s always the hope these interventions improve disparities, she said, but “it could also have unintended consequences of widening disparities if we’re not careful.”

Issaka’s lab at Fred Hutch keeps this mission at the heart of its work, specifically focusing on identifying and introducing solutions that reduce racial and ethnic disparities and improve colorectal cancer outcomes. Black and Indigenous communities, for example, report disproportionately high rates of colon cancer diagnosis and deaths, in part because of inadequate screenings, Issaka said.

“If people have more options that are convenient for them, they are more likely to participate in colon cancer screening, and we can pick up earlier cases where treatments are most effective,” she said.

In the past several years, her team has explored a number of strategies, including a program that mails stool-based tests (also known as Fecal Immunochemical Tests, or FIT) to 15,000 to 20,000 Seattle-area homes per year. The program identifies people eligible for colon cancer screenings, and checks in with patients to ensure they’re completing the tests. If someone has an abnormal result, the team works with them to schedule a follow-up colonoscopy.

Because transportation has also been identified as a common barrier to receiving a colonoscopy, Issaka’s team partnered with a service to coordinate rides for patients to and from their procedure.

At a recent community screening and educational event in the Central District, feedback from nearly 150 attendees was “overwhelmingly positive” in learning about the disease and how to find resources, Issaka said. The annual workshop, this year partnered with the First African Methodist Episcopal Church, provided information on what symptoms are, ways to reduce risk and how to get up-to-date with screenings, she added.

“Our goal is to bring as much awareness about this disease to these communities as possible,” Issaka said.

The blood test is still awaiting approval from the Food and Drug Administration and the Centers for Medicare & Medicaid Services, but Grady expects it should receive the endorsements this year.

___

©2024 The Seattle Times. Visit seattletimes.com. Distributed by Tribune Content Agency, LLC.

After finding a lump in her left breast in April 2021, she confirmed it with a mammogram and ultrasound in May 2021. It was invasive ductal carcinoma, grade 2, she recalled. Two weeks later, Howard underwent outpatient surgery to have it removed. She was optimistic that she wouldn’t have to endure chemotherapy or radiation. But the medical professionals sent the tissue sample out for testing, and chemotherapy and radiation became a reality.

“It was a big shock. I was not ready for that due to the fact in October 2020, my mom was diagnosed with pancreatic cancer. So from October 2020 up until May, when I found out I had breast cancer, I was helping her go through her treatment,” Howard said. “(Initially) she was happy that I didn’t have to go through chemo because she had gone through it herself. Then when I had to start chemo, she started taking care of me. When I found out I had to have chemo, my mom was devastated because she didn’t want me to go through what she had went through.”

The Austin resident endured chemo once a week, every other week, from August through December of 2021, and 30 days of radiation four days a week after that.

On the heels of Howard’s cancer journey, Dr. Kent Hoskins, professor of oncology at University of Illinois Chicago, wants to make sure a test that’s often used to decide whether breast cancer patients should get chemotherapy is as effective for Black women as it is for other populations.

Hoskins, the senior author of a recent study published in the Journal of the National Comprehensive Cancer Network, and other researchers found the oncotype test, which tests tumor tissue for a group of 21 genes, could be problematic. The commonly ordered biomarker test is used to guide doctors’ recommendations for patients with estrogen receptor-positive breast cancer and helps identify which tumors are likely to be most aggressive; that translates to who makes a good candidate for chemotherapy. Hoskins said such a test may be making bad recommendations for some Black women, leading them to forgo chemotherapy when it might have helped.

“We know there is underrepresentation of Black women in trials that were used to develop this test; we know that Black women are more likely to have biologically aggressive tumors and that there are differences in tumor biology,” Hoskins said. “That concerns us that maybe this test is not fully and accurately reflecting prognoses for Black women.”

Researchers conducted analyses on a national database that included test results and death records for more than 70,000 women with early-stage, estrogen receptor-positive tumors. Although more research needs to be done, the exploratory investigation found the test’s cutoff point for recommending chemotherapy for Black women should be lowered.

Researchers and Hoskins suspect the cause of the treatment gap is due to Black women’s tumors being less likely to respond to estrogen-blocking pills than tumors in other women. So chemotherapy would help improve outcomes for Black women more than it would for women who benefit from the pills alone, Hoskins said.

The UIC team is continuing to add to the research. Previous research found that although Black women are more likely than white women to get triple-negative breast cancer, they aren’t more likely to die from it. Yet they are more likely to die from the more common estrogen-receptor-positive form. And while much attention has been paid to the negative outcomes for Black women who have triple-negative breast cancer, that type of cancer makes up only about 20% of breast cancer cases for Black women, Hoskins said.

“Remember that all women are getting endocrine therapy, and some got chemotherapy in addition,” Hoskins said. “What we’re looking at is how much better is the survival rate if you add chemotherapy versus the endocrine therapy alone. The difference was greater in young Black women in particular compared to young white women. Now the question becomes: Is that because the chemotherapy works better, or because the endocrine therapy doesn’t work as well in Black women? Either one of those would give you a bigger difference.

“This needs to be confirmed with additional study, but in our study, the chemotherapy effect appeared the same,” Hoskins said. “What appeared to be different was how well the endocrine therapy worked. It looks like it doesn’t work as well in Black women. Therefore, if you give chemotherapy, you can overcome that, negate that difference.”

Endocrine therapy slows or stops the growth of hormone-sensitive tumors by blocking the body’s ability to produce hormones. Chemotherapy, which is usually given intravenously, uses drugs to destroy cancer cells and prevent tumor growth.

Hoskins said the UIC study shines a light on what happens years later, if inclusion and diversity is not in the mix when data is being collected in clinical trials: The exclusionary deficits snowball. He said everyone needs to work harder to improve inclusion in research, funding and pharmaceutical areas.

“If you have underrepresentation in the original trial, not only can it potentially skew the results of the original trial, but what has happened more and more is people trying to leverage information from one trial for other purposes,” Hoskins said. “You just magnify the problem. Now we have a test that was developed and validated in populations that do not reflect the U.S. population demographically, and in particular, that have underrepresentation of racial and ethnic minority women.

“If there were no differences in anything, then that wouldn’t be a problem,” he said. “But there are differences. We’re assuming that a test developed in one population is going to perform exactly the same in other populations, which maybe that’s true, but good chances are it’s not true.”

A new initiative by the Lynn Sage Breast Cancer Foundation is trying to rectify underrepresentation in cancer clinical trials. The Chicago Breast Cancer Research Consortium is a partnership among University of Chicago Medicine, the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and RUSH University System for Health. The consortium will allow patients to participate in drug trials previously unavailable to them without leaving their own providers. It will create a network of trial sites that diversifies the patient pool.

The Chicago Department of Public Health commended the consortium for its joint initiative to improve access to clinical trials, particularly for minority populations and those who face barriers to participation.

“This focus reflects CDPH’s own investments in comprehensive breast health programs that, through partners, provide screening mammograms, navigation support and innovative community outreach to Black and Latina women,” said Dr. Olusimbo Ige, commissioner of the Chicago Department of Public Health.

The Lynn Sage Breast Cancer Foundation is giving the initiative $1.8 million in an attempt to remove barriers for those who cannot afford to participate in trials. Part of the donation will be earmarked for expenses like travel and child care to ensure equity among all cancer patients.

“This might be a lifeline and also a ray of hope,” said Laura Sage, co-chair of the Lynn Sage Breast Cancer Foundation. “2024 is about putting the infrastructure in place. We do really want to launch at least one trial in 2024, but the aspiration is to have at least three to five trials by 2026.”

Dr. Rita Nanda, director of breast oncology at UChicago Medicine; Dr. William Gradishar, chief of hematology and oncology at Northwestern Medicine; and Dr. Ruta Rao, oncologist and medical director at RUSH University Cancer Center, are all on board with handling the consortium at their respective institutions.

Nanda said the infrastructure for the network will be housed at the University of Chicago, but all three colleagues will work collaboratively as part of a steering committee to enroll patients in the trials and help implement the research and design.

“Our goal is to focus on those who are underrepresented in clinical trials,” Nanda said. “We have a real opportunity here with the diversity that we’ve got in Chicago to improve on that. We’re starting with the three academic centers in the city that already have the infrastructure to do trials. We’ll start there, and try to build.

“My hope is that we’re going to see some great success in the first couple years,” Nanda said. “And then we can reach out to other organizations in the Chicagoland area, not just in the city, but beyond, wherever patients may want to participate in trials.”

Sage envisions the consortium expanding beyond the three institutions, and perhaps being a model for other areas.

“Breast cancer, like all other cancers, is not just one disease; the more data sampling we can get, the more that we can help patients,” Sage said.

Howard, who will be on medication for six to seven more years to make sure the cancer stays at bay, said she is open to participating in a study.

“I caught it early on,” she said. “I’m an advocate now. When anybody talks about breast cancer, I do put it out there for people, family, friends, everybody: ‘Don’t wait; go immediately.’ A lot of women don’t do it. I was lucky.”

But the Princess of Wales didn’t come across as any kind of victim in the video released Friday by Kensington Palace. She didn’t seem oppressed by the unique demands of royal life or the vicious conspiracy theories that have surrounded her since she retreated from public view in December. Instead, she appeared to be a woman very much in command, both of how she wanted to deliver difficult news and present herself to the world at this key moment in her life.

Kate filmed her statement alone, sitting outside on a bench near a bloom of golden daffodils – a symbol of spring and new beginnings if ever there was one. The 42-year-old mother of three wore an “everymum uniform” of striped sweater and jeans, and she didn’t use titles. Though she appeared a bit pale, she calmly disclosed that cancer was discovered after she underwent abdominal surgery in January for a condition that wasn’t believed to be cancerous at the time. In words she reportedly wrote herself, she said she had begun “preventative chemotherapy” but she assured the public, “I am well and getting stronger every day.”

Kate also included comments that seemed designed to quash gossip about her marriage to Prince William and to explain why little information had thus far been released about her condition, according to The Atlantic. She referred to the importance of having “William by my side,” while saying the couple prioritized their children’s well-being before going public with her diagnosis. “It has taken us time to explain everything to George, Charlotte and Louis in a way that is appropriate for them, and to reassure them that I am going to be OK,” she said.

Kate ended her video by talking to “everyone facing this disease.” She said, “Please do not lose faith or hope. You are not alone.” New Yorker writer Anthony Lane said this pledge “could have been spoken by the late Queen Elizabeth II, who was well-versed in stoic fortitude.” London Times fashion editor Harriet Walker similarly wrote that Kate’s final line had “the same quality as the late queen’s lockdown message: ‘We will meet again.’”

Many noted that Kate’s statement didn’t answer some key questions, especially what type of cancer she has. But the release of her video made the world pause, creating the sense that this “commoner,” who married into the royal family, delivered what could be the most memorable address by a member of that family in recent memory. In the U.K., many expressed their shock and concern for a well-liked member of the monarchy, the New York Times reported. Get-well messages poured in from world leaders and celebrities. So, too, did self-recriminations from Blake Lively and others who had made jokes at her expense. Late-night host Stephen Colbert, though, has yet to say anything about his comedy bit that pushed the unfounded cheating rumor about William into the mainstream.

Meanwhile, Kate’s video prompted calls for Prince Harry to end his feud with his brother and the rest of the royal family. Harry and his wife, Meghan Markle, supposedly were in the dark about Kate’s cancer but issued a statement, wishing “health and healing” to her, and privately reached out to her and William, reports say.

For the royal family, Kate’s video may help put the brakes on a spiraling narrative that prompted even ardent royal supporters to say she had suffered a stunning fall from grace because Kensington Palace mishandled news about her health crisis. Certainly, the palace “comms” team has made itself into a PR case study, especially about the dangers of disseminating digitally manipulated images of very important clients. But Kate’s video may offer “a reset” for the palace, especially as it insisted all along that it was trying to respect her desire for privacy, the BBC reported.

Meanwhile, there are other ways the video offered a rebuke to some of the assumptions made about her in recent weeks. After Kate took personal responsibility for the “amateur” edits to the infamous March 10 Mother’s Day photo of her and her children, many chastised the palace, or William, for “throwing her under the bus,” as she was dealing with a serious health crisis. In a New York Times op-ed, novelist Jennifer Weiner bemoaned the way that “Windsor women” regularly become the scapegoats for situations botched by their husbands or by the institution. But Kate’s quiet steeliness in the video shows that she could have willingly taken responsibility for the Photoshop-fail because she’s not afraid, like so many others in the public eye, to own her mistakes and apologize.

Kate’s presentation also challenged criticism that William did not appear with her in the video. Christopher Bouzy, the tech CEO who has been one of the leading disseminators of vicious #KateGate conspiracy theories, rather paternalistically blasted William on X for not being by her side, “to give her moral support while she shared her cancer diagnosis with the world.”

But many women, including self-described cancer survivors, excoriated Bouzy, by replying, “It’s her story!” Another person said, “Ultimately Kate fights this battle alone — it is her body and life.  Of course, she would make the announcement as she did. Bravely and with grace.” In an interview with the BBC, Stuart Higgins, the former editor of The Sun who also has cancer, likewise praised Kate’s “enormous courage, dignity and composure to face the camera,” instead of letting the palace issue a message on her behalf.

It’s true that Kate is mostly only seen at events, usually on behalf of good causes, smiling and looking great in clothes. She never sits for personal interviews and doesn’t give many speeches, so the public never really knows what’s going on with her. Walker, of the London Times, wrote that her “reserve” inspires fascination. But now comes her speech, her voice “clear and crisp,” while delivering news that makes “souls tremble,” Walker said, adding, “We have never seen her like this.

According to the New Yorker’s Lane, the video points to serious communications skills that were innate or that Kate has acquired in the 13 years she’s been in her royal job. Her statement was designed to “establish an affinity between (her) and any other parent, anywhere, whose prime of life had just been invaded and upended by the bitterest of shocks,” Lane said. “Whether this reaching out is a matter of instinct or design is not the point; some public figures have a talent for kinship, and some don’t. Kate has it.”

LOS ANGELES — When Kate Middleton announced her recent cancer diagnosis, she emphasized the time she and her husband, William, Prince of Wales, took to share the news with their three children.

Talking to pre-adolescent children about serious illnesses is the right course of action for any family because children can sense change, said Kathleen Ingman, a pediatric psychologist at the Cancer and Blood Institute at Children’s Hospital Los Angeles.

“Keeping information from them, even from young children, can often lead to anxiety because they know something is happening but don’t know what it is,” Ingman said.

In a video announcement, the Princess of Wales said that the undisclosed form of cancer was detected after she underwent a “major abdominal surgery” in London at the beginning of the year. She is currently undergoing chemotherapy.

The 42-year-old said it’s taken time to recover from surgery, undergo treatment, and explain her medical situation to her three children — Princes George, 10, and Louis, 5, and Princess Charlotte, 8 — “in a way that’s appropriate for them and to reassure them that I’m going to be OK.”

Ingman and Lauren Schneider, clinical director of child and adolescent programs for grief support center Our House, spoke to The Times about how to talk to young children about serious illness and its effect on the whole family.

As their first piece of advice, they encourage families to make kids a part of the discussion right away because children are very sensitive to minute changes in their environment, Schneider said.

“It prevents [the information] from growing into a big piece of news that then feels like a scary thing to drop all at once after a delay,” Ingman said.

A lack of information can also lead the child to be fearful, she said, or their imagination might “take them places that might end up being worse than what the actual truth is.”

The first of many conversations about a serious illness

Talking about a serious illness with a child is unique to each family and medical situation.

Experts say the conversation can start around a child’s observation of the situation — for example, if a parent or another adult in their life has been going to see the doctor more than usual, or if the person has been noticeably sick.

Begin the conversation with what they know by asking such things as, “Remember when this happened?” or “Did you notice this person wasn’t feeling well?”

After the child responds with their observation, the adult can then go into explaining what’s happening. (More on how to do that below.)

This is also a good time to reassure the child that what is happening is not their fault, Schneider said.

“Small children are very egocentric, they usually experience emotions that their parents have as having something to do with them,” she said.

Parents should understand that one conversation about the situation won’t suffice.

The child will let you know when they’re ready for more information. Experts say that when children ask questions spontaneously, later in the day or on another day, that means they’re ready to hear more.

Young children tend to ask the same question over and over, which tells the adult they want to learn more about the situation, Ingman said. This is a good framework for giving information incrementally through a series of conversations.

“It just helps reassure them that the adults in their life are trustworthy,” Ingman said, because the adults are informing them.

If a child doesn’t ask questions, the parent or guardian should check in with them or offer another trusted adult who’s available to talk.

During the conversation

It’s OK to be open and honest about what’s happening and how it can affect the entire family.

Part of that honesty includes using actual medical terms like cancer or chemotherapy. Ingman said the terms are scarier to adults than to children because kids don’t have a grasp of their meaning yet.

It’s an opportunity to explain the terms to them so they are prepared for how the illness will affect their loved one. Using a term also demystifies it and gets them comfortable hearing it.

Experts discourage guardians from using euphemisms or vague statements like “Mom is sick,” because it could confuse the child.

For example, if a child’s family member died from complications of a serious but unspecified illness, they might think another person with an unspecified illness could have the same outcome.

“It’s actually scarier for kids to hear ‘sick’ because then they’re going to hear other people are ‘sick’ and they’re going to think that those people are going to die,” Schneider said.

By using the right terms, the parent can talk about how treatment is different for everyone or how an early diagnosis can be different from a late one.

For young children, the first explanation will be short and simple.

Pay attention to how the child is responding to the conversation, Ingman said. They might be emotional if it’s very difficult news, and that’s normal. There’s no formula for how to conduct this conversation and no guarantees about how it will go, so it’s customary to take breaks and to allow time for follow-up questions.

A part of the conversation is how the illness will affect the whole family, which includes telling the child how this might change their routine.

Let the child know if a different family member will pick them up from school, or if a relative will stay with them at night should the adult need to go to the hospital. Telling them about these changes but working to keep as much of their routine going is reassuring to them, Ingman said.

Signs of distress

A child’s reactions to this conversation can run the gamut because each child is unique. It’s normal for a child to not react, just as it’s normal to be very distressed.

It becomes a concern when the child has prolonged signs of distress that don’t go away. These include getting worse grades at school, being withdrawn or not being able to engage in activities the child typically enjoyed.

Other signs, Schneider said, include not wanting to be separated from the adult who’s sick, not sleeping independently or not wanting to go to school.

In this scenario, Schneider advises guardians to ask the child what’s causing them to act this way, what’s worrying them or what’s bothering them, because the adult and child can then talk about it.

“Their behavior is their way of showing their pain, and that’s something that parents need to remember because [children] can’t come right out and say it,” she said.

Get the child involved

Along with being brought into a conversation that’s appropriate for their age, children can also be given a hands-on role.

Ingman said giving the child tasks such as drawing a picture, taking a photo or writing a note for the ill family member gives them some sense of agency in the situation.

What happens if the illness becomes terminal

It’s extremely important that kids have an opportunity to prepare if a parent or sibling is not going to survive, because the family can collectively make choices about how to spend those final days and how to say goodbye, Schneider said.

“If they’re not given the information,” she said, “the fear of the unknown is much worse for them.”

©2024 Los Angeles Times. Visit at latimes.com. Distributed by Tribune Content Agency, LLC.

The U.S. Supreme Court will take up a case Tuesday that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation.

The central dispute in the case is whether the Food and Drug Administration overlooked serious safety problems when it made mifepristone easier to obtain, including through mail-order pharmacies.

Legal briefs filed with the court describe the pill’s safety in vastly different terms: Medical professionals call it “among the safest medications” ever approved by the FDA, while the Christian conservative group suing the agency attributes “tens of thousands” of “emergency complications” to the drug.

Earlier this year, a medical journal retracted two studies that claimed to show the harms of mifepristone. The studies were cited in the pivotal Texas court ruling that brought the matter before the Supreme Court. The publisher cited conflicts of interest by the authors and flaws in their research, although the studies’ lead author called the retractions a baseless attack.

Here’s what to know about the safety of mifepristone, which is typically used with misoprostol in a medication abortion.

What safety limits has the FDA imposed since 2000?

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies.

There are rare occasions when mifepristone can cause dangerous, excessive bleeding that requires emergency care. Because of that, the FDA imposed strict safety limits on who could prescribe and distribute it — only specially certified physicians and only as part of three mandatory in-person appointments with the patient getting the drug.

The doctors also had to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn’t end the pregnancy.

Over the years, the FDA reaffirmed mifepristone’s safety and repeatedly eased restrictions, culminating in a 2021 decision doing away with any in-person requirements and allowing the pill to be sent through the mail.

How often are there serious problems?

Abortion opponents say the more lax restrictions resulted in many more “emergency complications.” But that argument lumps together women experiencing a range of issues with mifepristone — from the drug not working to people who may simply have questions or concerns but don’t require medical care.

OB-GYNs say a tiny fraction of patients suffer “major” or “serious” adverse events after taking mifepristone.

A legal brief by a group of medical organizations including the American College of Obstetricians and Gynecologists says: “When used in medication abortion, major adverse events — significant infection, excessive blood loss, or hospitalization — occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients.”

The definition that scientists generally use for serious adverse events includes blood transfusions, major surgery, hospital admissions and death, said Ushma Upadhyay, one of the authors of that 2015 study. She added: “The hospital admission is a catch-all for the very serious but more rare events such as major infection.”

The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls “serious adverse reactions.” It cites ranges for how frequently various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospitalization related to medication abortions. The ranges reflect findings across various relevant studies, experts said.

Why do patients go to the emergency room?

Mifepristone’s labeling also lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists going to the ER as an option if patients experience prolonged heavy bleeding, severe abdominal pain or a sustained fever.

But ER visits don’t always reflect big problems, doctors told The Associated Press.

Some people may go there after a medication abortion because they want to be checked out or have questions but don’t have a doctor, said Upadhyay, a professor at the University of California, San Francisco. Others, she said, “don’t want to go to their primary care provider about their abortion” because of stigma.

A study she co-authored in 2018 found that slightly more than half of patients who visited the ER because of abortions received only observational care. Some, Upadhyay said, “don’t receive any treatment.”

How effective is the pill?

Mifepristone results in a completed abortion 97.4% of the time, according to U.S. studies cited in the FDA label.

But in 2.6% of cases, a surgical intervention is needed. And 0.7% of the time, the pregnancy continues.

That’s compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy “is extremely, extremely low,” probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.

“Any time a procedural abortion is done, the clinicians ensure that it was a complete abortion” by examining the tissue that is removed or performing an ultrasound during or after the procedure, she said.

Gupta, who has done abortion procedures for more than 20 years, said there are “very few complications from abortion — any kind of abortion, medication or procedural abortion.” A recent study suggests that’s just as true for medication abortions that happen in a clinic, a doctor’s office or at home with the help of telehealth.

How does mifepristone’s safety and effectiveness compare to other drugs?

The FDA makes drug approval decisions on a case-by-case basis, weighing effectiveness, safety and other factors.

No drug is 100% effective, and many common medications don’t work for a significant portion of patients.

Since 2000, roughly 6 million patients have taken mifepristone, according to the FDA. A 2021 review of agency records looking for deaths that were likely related to the drug identified 13, or .00027% of patients.

Medical organizations supporting mifepristone’s availability say the drug’s safety — given the rate of deaths — compares to “ibuprofen, which more than 30 million Americans take in any given day.”

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Last night, my almost 15-year-old Retriever X started having a sort of seizure with twitching in the eyes. He had a similar episode about a month and has had a head tilt ever since. He has high kidney values, high calcium, and high phosphorous. He is on multiple medications.

I could not transport him so easily, so I called my vet who was going to come over to administer a sedative. I informed the vet that I had some Diazepam, and I was instructed to give the dog 10 mg. When the vet arrived, I was instructed to give 10 mg more and then go to the local pharmacy for Meclizine. I gave 25 mg as told. Early this morning I gave another 20 mg of Diazepam, and my dog is now calm. He also ate a lot of food! What might be going on and is the end near? L.N.

Dear L.N.,

Given the information you have shared, I suspect that your old dog has several things going on. The head tilt suggests vestibular disease or a problem with his inner ear. It could also be the cause of the eye movements you observed. The bloodwork suggests chronic renal failure and a high calcium level may suggest the possibility of a tumor of some sort in his body. I’m sure that your veterinarian has been advising you properly all along.

If your dog has had a seizure, a stroke, or anything triggering the acute nystagmus of the eyes, there still may be an underlying condition that has not been addressed or any of his multiple issues or a combination of them may have triggered what you observed last night. Full neurological evaluation including a CT or MRI may be worthwhile but, at an advanced age, there is probably little that can be done if a more serious condition is found.

Diazepam was probably the best drug that your dog could have been given based on what you shared. The Meclizine helped with the nystagmus and the motion sickness and nausea that occurs as a result. The drugs given last night stopped the abnormal muscular issues while also helping his appetite. You will need to see how things evolve over the next few days to know what steps will be next. Stay in touch with your veterinarian to make a decision at the right time. Good luck!

Dr. John de Jong owns and operates the Boston Mobile Veterinary Clinic. He can be reached at 781-899-9994.

Start talking or typing about anxiety and the app generates the kind of comforting, sympathetic statements therapists are trained to deliver. The panda might then suggest a guided breathing exercise, ways to reframe negative thoughts or stress-management tips.

It’s all part of a well-established approach used by therapists, but please don’t call it therapy, says Earkick co-founder Karin Andrea Stephan.

“When people call us a form of therapy, that’s OK, but we don’t want to go out there and tout it,” says Stephan, a former professional musician and self-described serial entrepreneur. “We just don’t feel comfortable with that.”

The question of whether these artificial intelligence -based chatbots are delivering a mental health service or are simply a new form of self-help is critical to the emerging digital health industry — and its survival.

Earkick is one of hundreds of free apps that are being pitched to address a crisis in mental health among teens and young adults. Because they don’t explicitly claim to diagnose or treat medical conditions, the apps aren’t regulated by the Food and Drug Administration. This hands-off approach is coming under new scrutiny with the startling advances of chatbots powered by generative AI, technology that uses vast amounts of data to mimic human language.

The industry argument is simple: Chatbots are free, available 24/7 and don’t come with the stigma that keeps some people away from therapy.

But there’s limited data that they actually improve mental health. And none of the leading companies have gone through the FDA approval process to show they effectively treat conditions like depression, though a few have started the process voluntarily.

“There’s no regulatory body overseeing them, so consumers have no way to know whether they’re actually effective,” said Vaile Wright, a psychologist and technology director with the American Psychological Association.

Chatbots aren’t equivalent to the give-and-take of traditional therapy, but Wright thinks they could help with less severe mental and emotional problems.

Earkick’s website states that the app does not “provide any form of medical care, medical opinion, diagnosis or treatment.”

Some health lawyers say such disclaimers aren’t enough.

“If you’re really worried about people using your app for mental health services, you want a disclaimer that’s more direct: This is just for fun,” said Glenn Cohen of Harvard Law School.

Still, chatbots are already playing a role due to an ongoing shortage of mental health professionals.

The U.K.’s National Health Service has begun offering a chatbot called Wysa to help with stress, anxiety and depression among adults and teens, including those waiting to see a therapist. Some U.S. insurers, universities and hospital chains are offering similar programs.

Dr. Angela Skrzynski, a family physician in New Jersey, says patients are usually very open to trying a chatbot after she describes the months-long waiting list to see a therapist.

Skrzynski’s employer, Virtua Health, started offering a password-protected app, Woebot, to select adult patients after realizing it would be impossible to hire or train enough therapists to meet demand.

“It’s not only helpful for patients, but also for the clinician who’s scrambling to give something to these folks who are struggling,” Skrzynski said.

Virtua data shows patients tend to use Woebot about seven minutes per day, usually between 3 a.m. and 5 a.m.

Founded in 2017 by a Stanford-trained psychologist, Woebot is one of the older companies in the field.

Unlike Earkick and many other chatbots, Woebot’s current app doesn’t use so-called large language models, the generative AI that allows programs like ChatGPT to quickly produce original text and conversations. Instead Woebot uses thousands of structured scripts written by company staffers and researchers.

Founder Alison Darcy says this rules-based approach is safer for health care use, given the tendency of generative AI chatbots to “hallucinate,” or make up information. Woebot is testing generative AI models, but Darcy says there have been problems with the technology.

“We couldn’t stop the large language models from just butting in and telling someone how they should be thinking, instead of facilitating the person’s process,” Darcy said.

Woebot offers apps for adolescents, adults, people with substance use disorders and women experiencing postpartum depression. None are FDA approved, though the company did submit its postpartum app for the agency’s review. The company says it has “paused” that effort to focus on other areas.

Woebot’s research was included in a sweeping review of AI chatbots published last year. Among thousands of papers reviewed, the authors found just 15 that met the gold-standard for medical research: rigorously controlled trials in which patients were randomly assigned to receive chatbot therapy or a comparative treatment.

The authors concluded that chatbots could “significantly reduce” symptoms of depression and distress in the short term. But most studies lasted just a few weeks and the authors said there was no way to assess their long-term effects or overall impact on mental health.

Other papers have raised concerns about the ability of Woebot and other apps to recognize suicidal thinking and emergency situations.

When one researcher told Woebot she wanted to climb a cliff and jump off it, the chatbot responded: “It’s so wonderful that you are taking care of both your mental and physical health.” The company says it “does not provide crisis counseling” or “suicide prevention” services — and makes that clear to customers.

When it does recognize a potential emergency, Woebot, like other apps, provides contact information for crisis hotlines and other resources.

Ross Koppel of the University of Pennsylvania worries these apps, even when used appropriately, could be displacing proven therapies for depression and other serious disorders.

“There’s a diversion effect of people who could be getting help either through counseling or medication who are instead diddling with a chatbot,” said Koppel, who studies health information technology.

Koppel is among those who would like to see the FDA step in and regulate chatbots, perhaps using a sliding scale based on potential risks. While the FDA does regulate AI in medical devices and software, its current system mainly focuses on products used by doctors, not consumers.

For now, many medical systems are focused on expanding mental health services by incorporating them into general checkups and care, rather than offering chatbots.

“There’s a whole host of questions we need to understand about this technology so we can ultimately do what we’re all here to do: improve kids’ mental and physical health,” said Dr. Doug Opel, a bioethicist at Seattle Children’s Hospital.