Space Flights Provoke Tension Headaches, Migraine

 Space flight appeared to provoke headaches in healthy astronauts, a prospective study showed.

Of 24 astronauts who participated in long-haul space flights -- ones that lasted at least 10 days -- 91.7% experienced one or more headaches during a total of 3,596 space days, reported Willebrordus P. J. van Oosterhout, MD, PhD, of Leiden University Medical Center in the Netherlands, and co-authors.

Most episodes (89.9%) were tension-type headaches and 10.1% were migraine, the researchers reported in Neurologyopens in a new tab or window. Episodes in the first week of space travel were more likely to have a migraine phenotype, while those in later periods were more likely to be tension-type (P=0.0002).

The incidence of space headache, defined by the International Classification of Headache Disordersopens in a new tab or window, was much higher than expected, van Oosterhout noted.

"We don't know why these headaches occur," he wrote in an email to MedPage Today. "We hypothesize that different mechanisms are involved for the early versus later headache episodes."

In the first week of space travel, the body has to adapt to a lack of gravity, which is known as space adaptation syndrome, van Oosterhout said. "This phenomenon is similar to motion sickness and can cause nausea, vomiting, dizziness, and headaches," he pointed out.

"The later headaches, we think, could result in an increase in intracranial pressure due to the cephalad fluid shift," he added. "Due to microgravity, there is more fluid accumulating in the upper part of the body and head -- both intracranial and extracranial -- thereby resulting in higher pressure in the skull."

Prior research has shown a number of brain changes associated with long space flight durations. Changes in the eye and brainopens in a new tab or window are apparent, for example, and long space flights have been shown to expand combined brain and cerebrospinal fluid volumesopens in a new tab or window significantly.

The study involved 24 astronauts from the European Space Agency, the U.S. National Aeronautics and Space Administration (NASA), and the Japan Aerospace Exploration Agency who were assigned to International Space Station expeditions for up to 26 weeks from November 2011 until June 2018. Mean age was about 47 and 96% of the group were men.

Preflight headache history showed that nine astronauts reported never having any headaches, while three said they had experienced a headache interfering with daily activities in the past 12 months. None had a history of recurrent headaches or had ever been diagnosed with migraine.

The astronauts completed a daily digital questionnaire during the first 7 days of space flight and a weekly questionnaire until the end of the mission. In total, 378 headache episodes were reported, and the median individual headache frequency was nine. Detailed information was available for 189 headaches.

In the first week, 51 headache episodes were reported; these were more likely to be accompanied by nausea, vomiting, nasal congestion, and facial edema. In the following weeks, there were 327 in-flight headache episodes. There was no difference in the proportion of astronauts with a headache episode in the first week compared with later weeks.

Headache occurrence was not tied to temperature, ambient pressure, or levels of O₂ and CO₂ (all P>0.05). Severity and treatments of headaches were similar, with more than half (55.6%) using acute anti-headache medication, 22.4% using other medication, and 41.1% using alternative treatments.

In the 3 months after returning to Earth, no astronaut reported any headaches.

In a separate retrospective study, van Oosterhout and colleagues reported that 54.8% of 42 astronauts said they had experienced one or more headache episode during a mission. Nasal congestion was the most common accompanying symptom.

"Further research is needed to unravel the underlying causes of space headache and explore how such discoveries may provide insights into headaches occurring on Earth," van Oosterhout said in a statement. "Also, more effective therapies need to be developed to combat space headaches, as for many astronauts, this is a major problem during space flights."

Disclosures

The study was supported by the Netherlands Organization for Scientific Research.

Van Oosterhout had nothing to disclose. One co-researcher reported a grant from User Support Program Space Research, Netherlands Organization for Scientific Research.

Primary Source

Neurology

Source Reference: opens in a new tab or windowvan Oosterhout WPJ, et al "Frequency and clinical features of space headache experienced by astronauts during long-haul space flights" Neurology 2024; DOI: 10.1212/WNL.0000000000209224.

https://www.medpagetoday.com/neurology/migraines/109162

'Slowing of Peripheral Artery Disease: Another Liraglutide Benefit?'

 Liraglutide (Victoza), a type 2 diabetes drug, may help prevent peripheral artery disease (PAD) progression, the small, open-label STARDUST trial suggested.

Over 6 months, adults with type 2 diabetes on subcutaneous liraglutide had a significantly greater increase of transcutaneous oxygen pressure (TcPO2) compared with conventional treatment (14.2 mmHg vs 2.9 mmHg, estimated treatment difference 11.2 mmHg, 95% CI 8.0-14.5 mmHg), according to Maria Ida Maiorino, PhD, of the University of Campania Luigi Vanvitelli in Naples, Italy, and colleagues.

A total of 89% of liraglutide patients achieved the coprimary endpoint -- a 10% increase of TcPO2 from baseline -- versus only 46% of the control group (relative risk 1.91, 95% CI 1.26-2.90), the researchers reported in JAMA Network Openopens in a new tab or window.

"According to these data, we could expect that the administration of GLP-1 RAs [receptor agonists] may represent a proper strategy in patients with PAD and diabetes, determining a reduction or a delay of the onset of lower-extremity complications," they wrote. "This finding may be relevant in the prevention of PAD clinical progression because the diagnosis of PAD often occurs with the appearance of critical limb ischemia or gangrene, which usually result in lower-extremity amputation."

PAD-related amputation in people with diabetes commonly leads to permanent disability and adds a significant economic burden to the healthcare system, they pointed out.

The researchers noted that the increase in TcPO2 "was consistent over time within the liraglutide group, with significant differences compared with the individuals randomized to the control group," adding that this was the first trial of patients with type 2 diabetes and PAD to show that liraglutide increased peripheral perfusion.

"Liraglutide, as well as other GLP-1 RAs, may determine its effect on peripheral perfusion through both microvascular and macrovascular mechanisms," they wrote. "Liraglutide is effective on glycometabolic outlook, which affects the cardiovascular risk profile."

"We chose liraglutide because it was the GLP-1 receptor agonist with the greater number of evidence about lower extremity complications, at the time of the protocol drafting," Maiorino told MedPage Today. While this may potentially be a class effect with all GLP-1 receptor agonists, she said it needs to be confirmed in future studies.

First established for type 2 diabetes, GLP-1 RAs have recently become popular for weight management. Liraglutide was initially approvedopens in a new tab or window by the FDA in 2010 at the 1.8-mg dose for type 2 diabetes. At the 3-mg dose, liraglutide (Saxenda) was approved for chronic weight managementopens in a new tab or window in 2014 for adults, which was extended to teensopens in a new tab or window in 2020.

More recently, this class of agents has moved into the cardiovascular protection space, with the GLP-1 receptor agonist semaglutide (Wegovy)opens in a new tab or window approved to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight.

In the STARDUSTopens in a new tab or window study, Maiorino's group noted several other significant mean changes from baseline after 6 months of treatment:

• HbA1c: -0.4% for the liraglutide group vs -0.02 for the control group
• Body weight: -2.3 kg (5.1 lb) vs -1.2 kg (2.6 lb)
• BMI: -1.1 vs -0.3
• Systolic blood pressure: -5.4 mmHg vs -5.3 mmHg
• C-reactive protein: -0.4 mg/dL vs -0.03 mg/dL
• Urine albumin to creatinine ratio: -90.5 mg/g vs 28.8 mg/g
• 6-minute walking test: 364.0 m vs 340.1 m

Compared with the control group, liraglutide-treated patients had significantly greater drops in C-reactive protein, interleukin 6, luteinizing hormone, urine albumin to creatinine ratio, and 6-minute walking distance.

The researchers said these results "suggest a potential beneficial effect of liraglutide in improving endothelial function in people with type 2 diabetes and PAD," but also noted that the two groups didn't differ much in glycometabolic status by the end of the trial.

The final analysis assessed 55 participants (27 randomized to liraglutide and 28 to the control group) who were enrolled between February 2021 and June 2022 in Italy. The average age at baseline was 67.5 and 78% were male.

Median HbA1c levels were 6.9% and average TcPO2 levels were 40.3 mmHg. All patients had to have TcPO2 of the foot between 49 to 30 mmHg at the screening visit, plus an HbA1c between 6.5% to 8% while on stable glucose-lowering medication doses. Patients were excluded if they had used a GLP-1 receptor agonist in the prior 3 months.

Patients in the liraglutide group were started on a 0.6-mg once-daily liraglutide subcutaneous injections at approximately the same time each day, titrated up on a weekly schedule by a 0.6-mg increase to a target dose of 1.8 mg or the maximum tolerated. Patients in the control group received conventional treatment of cardiovascular risk factors. Patients in both groups were given tailored therapeutic prescriptions to manage blood glucose levels and cardiovascular risk factors.

The small sample size and small number of women -- though PAD epidemiology tends to be male-centric -- were noted as limitations of the trial.

Disclosures

The trial was partially funded by the PhD program of Translational Medicine of the University of Campania Luigi Vanvitelli in Naples, Italy.

Maiorino and co-authors reported relationships with Novo Nordisk, Eli Lilly, Sanofi, Roche, and Medtronic.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowCaruso P, et al "Liraglutide for lower limb perfusion in people with type 2 diabetes and peripheral artery disease" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.1545.

https://www.medpagetoday.com/endocrinology/diabetes/109160

Why GSK Bailed on Its Maternal RSV Vaccine

 GSK's abandoned maternal respiratory syncytial virus (RSV) vaccine protected infants from severe RSV, final results of a phase III trial indicated, but those positive outcomes came at the expense of an unexplained higher risk for preterm birth.

For newborns up to 6 months of age, efficacy with the RSV prefusion F protein-based vaccine (RSVPreF3-Mat) during pregnancy arrived at 65.5% (95% credible interval [CrI] 37.5-82.0) and 69% (95% CrI 33.0-87.6), respectively, against either any or severe RSV-associated lower respiratory tract disease, according to Philip Dormitzer, MD, PhD, of GSK in Waltham, Massachusetts, and colleagues.

But a 37% increased risk of preterm birth in the vaccination arm led the company to halt the trial in February 2022 and cease further development of the maternal vaccine, the researchers reported in the New England Journal of Medicineopens in a new tab or window.

In total, 6.8% of infants in the vaccination arm were born preterm, as compared with 4.9% of those in the placebo group (RR 1.37, 95% CI 1.08-1.74). For every 54 infants born to women who received the vaccine, one additional preterm birth occurred.

"No other safety signal has been observed among infant or maternal participants in any trial of RSVPreF3-Mat," the study authors wrote, adding that a previous phase II trialopens in a new tab or window and unpublished data from a phase III trial found no association between the vaccine and preterm births.

Dormitzer and investigators also considered potential effects of additional vaccines received during pregnancy -- such as vaccines for COVID, the flu, tetanus, and tetanus-diphtheria, none of which have been linked to an increased risk for preterm birth. Receipt of additional vaccines during pregnancy was associated with a lower incidence of preterm birth in both the vaccine and placebo groups, but the reduction in risk was greater in the placebo group.

RSV is the leading cause of hospitalization among infants in the U.S., with 2% to 3% of infants younger than 6 months of age hospitalized for RSV infection annually, noted Sonja Rasmussen, MD, of Johns Hopkins University School of Medicine in Baltimore, and Denise Jamieson, MD, MPH, of the University of Iowa Carver College of Medicine in Iowa City, in an accompanying editorialopens in a new tab or window.

"Whether the safety signal in the RSVPreF3-Mat trial is real or occurred by chance is unknown," they wrote.

Currently, only Pfizer's bivalent RSV vaccine (Abrysvo) is approved and recommendedopens in a new tab or window for use during pregnancy to protect newborns from serious RSV-related outcomesopens in a new tab or window. However, concerned with a possible risk for preterm birth, the FDA restricted its use to between weeks 32 and 36 of gestation. (The monoclonal antibody nirsevimab [Beyfortus] is also recommended for use in newborns entering their first RSV season, provided the mother did not receive an RSV vaccine during pregnancy.)

With more maternal vaccines in development, the editorialists said that "continued focus on balancing the benefits with the potential risks of maternal vaccination will be essential as we move forward to protect infants from the severe effects of infectious diseases."

The current study, GRACE or RSV MAT-009opens in a new tab or window, was a phase III double-blind trial that enrolled 5,328 pregnant women ages 18-49 across 24 countries. Women were randomized 2:1 to receive the RSV vaccine or placebo between 24 and 34 weeks of gestation.

Most of the women (80%) were between the ages of 18 and 34 years, with 17% ages 35 to 39 and the remaining over 40. When it came to race and ethnicity, 47% were white, 33% were Hispanic or Latino, and 14% were Black. About half were of low to middle income.

At day 43 after birth, data were available for 3,494 infants in the vaccine group and 1,739 in the placebo group. Of infants in the vaccine group, 237 were born prematurely (<37 weeks of gestation) versus 86 in the placebo group. The overall gestational age of infants was approximately 39 weeks and 97% had an Apgar score of 7 to 10 at 5 minutes.

Very preterm (28 to <32 weeks) or extremely preterm (<28 weeks) births occurred among 5.5% of infants in the vaccine group and 2.3% in the placebo group.

Neonatal deaths occurred in 0.4% of infants in the vaccine group and 0.2% of those in the placebo group (RR 2.16, 95% CI 0.62-7.56). This imbalance was probably attributable to the higher rate of preterm births in the vaccine group, the authors posited.

In post hoc analyses, Dormitzer and colleagues attempted to identify how the vaccine may have led to the increased risk of preterm birth, but noted that the mechanisms for the phenomenon remain unknown. "The intervals from vaccination to preterm delivery generally ranged from weeks to months," they wrote, "which suggests the absence of a direct effect of vaccination on mechanisms that initiated preterm birth." They found no association between inflammatory processes, as measured by cytokine levels in the mothers, and preterm birth.

Of note, the relative risk of preterm births in the vaccine group was highest among low- and middle-income countries (RR 1.56, 95% CI 1.17-2.09), where there is the greatest need for effective maternal RSV vaccines. Also, the greatest difference occurred when the Delta variant of the COVID pandemic was most pronounced, peaking between August and December 2021, the authors pointed out.

SARS-CoV-2 infection, especially during the Delta wave, has been associated with an increased risk of preterm birth, but that fact alone still could not account for the higher incidence of preterm births in the vaccine group, they said.

Disclosures

The study was funded by GlaxoSmithKline Biologicals.

Dormitzer and other coauthors of the study are employees of GSK.

Rasmussen has received personal fees from Biohaven, Myovant, Harmony, and Axsome.

Jamieson had no disclosures.

Primary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowDieussaert I, et al "RSV prefusion F protein-based maternal vaccine -- preterm birth and other outcomes" N Engl J Med 2024; DOI: 10.1056/NEJMoa2305478.

Secondary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowRasmussen SA, Jamieson DJ "Maternal RSV vaccine -- weighing benefits and risks" N Engl J Med 2024; DOI: 10.1056/NEJMe2401072.

https://www.medpagetoday.com/infectiousdisease/vaccines/109161

England's NHS Clinics No Longer Offering Puberty Blockers to Youth Not in Trials

 England's National Health Service (NHS) will no longer offer puberty-blocking medications to youths under 18 in its clinics, unless they are enrolled in clinical trials planned for the end of the year.

"Puberty suppressing hormones (PSH) are not available as a routine commissioning treatment option for treatment of children and young people who have gender incongruence/gender dysphoria," according to the NHS final policy opens in a new tab or window.

"We have concluded that there is not enough evidence to support the safety or clinical effectiveness of PSH to make the treatment routinely available at this time,"the policy report noted.

According to The Guardianopens in a new tab or window, the health service plans to replace its Gender Identity Development Service with two clinics -- one at the Great Ormond Street Hospital in London, which confirmed it was partnering with the NHS for the new national service, and Alder Hey Children's Hospital in Liverpool.

Patients already being prescribed the medications will continue to have access to them. The Guardian reported that there are fewer than 100 patients currently being prescribed puberty blockers. However, the interim reportopens in a new tab or window commissioned by the NHS said that as of 2021, there were 4,600 young people on the waiting list for gender care and 2,500 more being referred for care per year.

An NHS spokesperson told ABC Newsopens in a new tab or window that a study on the use of these medications in youth is planned to begin in December of this year, with eligibility criteria not yet defined.

The change comes after a public consultation period, and reportsopens in a new tab or window commissioned by the NHS that concluded that existing literature concerning gonadotropin-releasing hormone (GnRH) agonists was "of very low certainty" and that "gaps in the evidence base" prevented them from giving definitive guidance.

GnRH agonists are used in other medical treatments, including for precocious puberty, endometriosis, and prostate cancer, as well as inducing ovulation. Medical organizations backing access to gender-affirming care for youth, including medications when indicated, include the American Medical Associationopens in a new tab or window, the American Psychiatric Associationopens in a new tab or window, the Endocrine Societyopens in a new tab or window, and the American Academy of Pediatricsopens in a new tab or window.

Mermaids, a British advocacy group for trans youth, told MedPage Today in an email that "this announcement is deeply disappointing, and a further restriction of support offered to trans children and young people through the NHS, which is failing trans youth. There were virtually no first appointments offered in 2023, with ever-growing waiting lists of over five years."

However, they characterized the change as a pause.

"Those currently prescribed puberty blockers won't see any changes to their treatment, and this is a pause on prescribing -- not a ban," the group said. "It's also important to note that puberty blockers can be just one possible part of a young person's gender journey. However, this news still comes as a blow and will deeply affect our communities."

The change in policy comes as 23 states in the U.S. have banned or restricted gender-affirming care for youthopens in a new tab or window, often citing U.K. and European clinical reviews and policy changes.

In an email to MedPage Today, Joshua Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery in New York City, wrote, "We have many decades of experience with the puberty pausing medications referred to as 'puberty blockers' and we have not found harm in adults who were treated with these medications when they were adolescents."

In a Timeopens in a new tab or window story, Jack Turban, MD, director of the Gender Psychiatry Program at the University of California San Francisco, said, "Research consistently links gender-affirming medical care (including pubertal suppression) for adolescent gender dysphoria to improved mental health outcomes."

"It is sad to see this medical care, which many adolescents dramatically benefit from, be so woefully politicized," he added.

The NHS did not respond to a request for comment.

https://www.medpagetoday.com/special-reports/features/109186

More States Cut Training Requirements for Some International Medical Graduates

 Nearly a year ago, Tennessee became the first state in the U.S. to scrap residency requirements for certain international medical graduates (IMGs), opening up an alternative pathway to permanent licensure.

Since then, more states have enacted or are close to enacting similar legislation, and others have shortened residency requirements for some IMGs.

A MedPage Today analysis found a total of 15 states have passed or are considering legislation around establishing alternative pathways to licensure for IMGs.

"It's a really interesting time. There's so much activity," Hao Yu, PhD, a health policy expert at Harvard Medical School in Boston and author of a New England Journal of Medicine perspectiveopens in a new tab or window on the Tennessee law, told MedPage Today.

Supporters say cutting residency requirements aids a group that has historically faced barriers to obtaining a U.S. medical license, such as being the least likely to match into a residency program. At the same time, it can help solve workforce issues, such as filling an unmet need for clinicians in rural or underserved areas.

But physicians have raised questions and concerns. Should these candidates be held to some type of national standard after their supervision, especially if state laws continue to vary widely? Doctors have also raised alarms that hospitals potentially benefit from a less expensive source of labor -- and wonder if it will cost them their jobs.

Some IMGs Can Now Bypass Residency

A total of four states have or are very close to having eliminated residency requirements for certain IMGs.

In April 2023, Tennessee Gov. Bill Lee (R) signed into lawopens in a new tab or window a bill that enables IMGs to skip residency and instead get a 2-year provisional license to work at a healthcare facility that has an accredited residency program. After 2 years, they can apply for a full license.

However, applicants must already be "legally entitled to live or work in" the U.S., and must obtain their own visa or permanent resident card.

They also must be certified by the Educational Commission for Foreign Medical Graduates (ECFMG), now a division of Intealth; pass the U.S. Medical Licensing Exam (USMLE) Step 1 and 2 CK; and have completed at least a 3-year residency at an accredited international program.

The Tennessee law goes into effect on July 1 of this year.

"IMGs are really excited by this new law," Yu told MedPage Today. "They want to take advantage of it."

In September 2023, Illinois Gov. J.B. Pritzker (D) enacted similar legislationopens in a new tab or window, wherein IMGs can work for 2 years with a provisional license under the supervision of a licensed physician, and then can apply for a full license.

Like Tennessee, IMGs would have to be legally able to work in the U.S., but unlike Tennessee, the law mandates that they must work in medically underserved areas. It takes effect on Jan. 1, 2025.

"We really see this as having the potential to support thousands of IMGs in Illinois, to move into skill-aligned work and enter into the healthcare industry," said Avigail Ziv, MPH, vice president of programs at Upwardly Global, an advocacy organization that championed the Illinois legislation. "And not only that, but to address the real shortages that exist in the healthcare industry and workforce."

Two additional states are close to enacting legislation that cuts residency requirements and establishes an alternative, permanent pathway to licensure for some IMGs: Florida and Virginia.

In both cases, relevant bills have passed the state House and Senate, and await each governor's signature.

The Florida provisionopens in a new tab or window will allow IMGs to skip residency requirements if they've completed similar post-graduate training that meets state and national standards. It's part of a larger healthcare workforce bill awaiting the signature of Gov. Ron DeSantis (R).

In Virginiaopens in a new tab or window, IMGs will be able to obtain a 2-year provisional license to work at an academic center with an accredited residency program. After that, they can apply for a full, unrestricted license to practice medicine.

Other Pathways

Four states have taken other actions around residency requirements for IMGs, including cutting down residency length and establishing a temporary pathway for licensure.

Alabama recently passed the Physician Workforce Actopens in a new tab or window, with a provision that allows IMGs to apply for a license a year earlier during their training -- essentially cutting residency requirements from 3 to 2 years.

Colorado also recently shortened residency requirements for IMGs from 3 years down to 1 yearopens in a new tab or window.

Idaho and Washington have created temporary pathways to licensure for IMGs. In Idaho, IMGs can obtain a temporary licenseopens in a new tab or window if they are "forcibly displaced" and if they've applied to an accredited residency program in the state. They'll also have to work in an underserved area for at least 3 years after they've completed residency.

In Washington, IMGs who have been a state resident for at least a year can obtain a temporary 2-year licenseopens in a new tab or window, with the option to renew for another 2-year period.

Legislation targeting IMG licensing has been introduced in six other states: Arizona, Iowa, Massachusetts, Missouri, Nevada, and Vermont. Arizonaopens in a new tab or window would shorten its residency requirements to 1 year, and Nevadaopens in a new tab or window would issue a temporary license only. Proposed legislation in Iowaopens in a new tab or window, Massachusettsopens in a new tab or window, Missouri,opens in a new tab or window and Wisconsinopens in a new tab or window would offer a provisional license for a set time period, after which IMGs can apply for a full license. The Vermont billopens in a new tab or window seeks to establish a work group to consider Tennessee's legislation.

But it remains to be seen whether any of these bills will advance.

Striking a Balance

Even though a quarter of all U.S. physicians are IMGs, according to the American Medical Association opens in a new tab or window(AMA), it's not easy for them to get their U.S. medical licenses.

Having to go through a U.S. residency program, on top of training they've already received in their licensing countries, is time-consuming and difficult, on top of being costly, Yu said.

That's if they can even get a position, he added, noting that IMGs are the least likely of all medical graduates to match into a residency program.

At the same time, the U.S. needs healthcare workers, according to Ziv of Upwardly Global, which estimates there are 165,000 unemployed or underemployed immigrants with international healthcare degrees already in the U.S.

Their services can be especially helpful as the U.S. population ages, and as demand rises for doctors in rural and other medically underserved areas.

"They come with knowledge and years of experience," she said. "How can we leverage that talent to support our healthcare industry?"

She gave the example of a woman who recently immigrated to the U.S. who was a surgeon in Afghanistan: "She has years of experience and depth of expertise, but she's not able to" work as a surgeon in the U.S. at this time.

But medical societies are hesitant to comment on the legislation popping up across the country, and some doctors have shared concerns about IMGs skipping residency training.

Yarnell Beatty, general counsel at the Tennessee Medical Association (TMA), said some of the group's members reached out after the legislation was passed last year.

"Some expressed concerns about it, in terms of the ability to demonstrate quality," Beatty told MedPage Today.

Yu said there could be a role for a national organization to develop a standard of quality that would have to be met following completion of provisional licenses.

"There's heterogeneity across medical training, and residency standardizes things," Yu said. "How can we ensure quality during the 2-year provisional licensing period?"

Eric Holmboe, MD, CEO of Intealth, noted that the Tennessee legislation specifically requires ECFMG certification as part of its credentialing process, and noted that the nature of oversight "varies a bit by state, which is honestly a bit of a challenge."

He added that Intealth, the Federation of State Medical Boards (FSMB), and the Accreditation Council for Graduate Medical Education (ACGME) have formed a work group that's meeting in April to "talk about how we can create a more standardized process. One that states could use as part of a pilot program that would have an evaluation to see if this alternative pathway is producing the outcomes that these states hope for."

Humayun Chaudhry, DO, president and CEO of FSMB, told MedPage Today that some states have asked about his organization's position on the legislative changes, which in part prompted the upcoming meeting in April.

"The primary mission of state medical boards is to protect the public, and we want to make sure that access to care is being addressed though this particular approach, and that patients are protected and not harmed," Chaudhry said. "We're going to be starting some conversations about criteria or competencies that a state board should expect before they issue a temporary license."

Beatty also said that some TMA members raised concerns about potentially losing their jobs, as the academic medical centers in Tennessee where provisional licensees are required to practice find a source of less expensive labor.

"They were concerned that these graduates would come in and accept cheaper salaries, and established physicians might be pushed out," he said.

Bryan Carmody, MD, MPH, a pediatric nephrologist at Eastern Virginia Medical School in Norfolk, who has long studied data on residency and the Match process, said that the influx of labor would be good for academic medical centers in Tennessee.

"They can hire experienced physicians at bargain rates," Carmody said in a video on the topic.

In an interview, Carmody noted to MedPage Today that Tennessee and Florida are "probably the two biggest HCA [Healthcare] states. You have to think that ultimately, one beneficiary of this are health systems who get access to more abundant and cheaper physician labor."

Beatty said "hundreds of potential applicants" have contacted the Tennessee Board of Medical Examiners (TBME), interested in applying. A spokesperson for the TBME said applications "are not being accepted yet" but told MedPage Today that the legislation will be discussed at an upcoming board meeting in May.

Beatty added that TMA originally deferred to TBME on reviewing the bill, and TMA remained neutral on the bill. He noted that placeholder legislation has been introduced with the goal of "tamping back" the law.

The AMA told MedPage Today that it "defers to local state medical associations to take the lead on state-level legislation as the voice and advocate of local physicians in the state legislature," noting that it has at the same time "adopted numerous policies that demonstrate strong support for [IMGs] during and after training."

These include allowing state medical boards to have an alternate set of criteria for granting medical licenses outside of going through a U.S. residency program; encouraging boards to evaluate the progress of programs aimed at reducing barriers to licensure for IMGs; and encouraging relevant stakeholders to "study the personal and financial consequences" of not matching for IMGs.

https://www.medpagetoday.com/special-reports/exclusives/109168

Meth-Related Cardiomyopathy: Where the Biggest Clusters Are

 The American West has seen the biggest surge of cardiomyopathy-associated hospital admissions among methamphetamine users, based on 13 years of the latest available hospital admission data.

The National Inpatient Sample (NIS) showed that methamphetamine-related cardiomyopathy admissions spiked by 231% from 2008 to 2020 nationwide -- whereas overall admissions for heart failure increased just 12% during this period, according to Mohammad Bhuiyan, PhD, of Louisiana State University Health Sciences Center at Shreveport, and colleagues.

They reported various geographical and social disparities evident across methamphetamine-related cardiomyopathy admissions:

• By sex: increases of 345% for men and 122% for women
• By race: increases of 271% for white, 254% for Black, 565% for Hispanic, and 645% for Asian groups
• By region: increases of 530% in the West and 200% in southern states. In contrast, the Northeast did not show any significant change.

"Demographically, cardiomyopathy among methamphetamine users occurs predominantly in middle-aged patients and men and tends to be concentrated more in the western region of the United States," Bhuiyan's team reported in JACC: Advancesopens in a new tab or window.

Methamphetamine (popularly known as "meth") is a highly addictive psychostimulant drug. It is available as a prescription drug for obesity and attention deficit-hyperactivity disorder, while illegal versions are derived from over-the-counter drugs. An estimated 1.6 million U.S. adultsopens in a new tab or window reported past-year methamphetamine use in 2015-2018, the CDC estimates.

Methamphetamine has known links to cardiovascular disease (CVD), including cardiomyopathy, heart failureopens in a new tab or window, pulmonary hypertension, and coronary artery disease.

"Given the rapidly increasing global burden of methamphetamine-associated cardiomyopathy, this work ... should be a call to action for researchers, healthcare providers, and policymakers to fight this growing epidemic. Importantly, the healthcare system must also acknowledge and address its bias towards patients with substance use disorders," urged cardiologist Nisha Parikh, MD, MPH, of University of California San Francisco Health, and two colleagues.

In an accompanying editorialopens in a new tab or window, the trio said the present NIS study extends prior work showing that meth-associated heart failure (MethHF) hospitalizations increased at an exponential rate between 2002 and 2014, particularly on the West Coast and among men, younger patients, and lower socioeconomic groups. Also disproportionately affected were people of Hispanic, Native American, and Asian/Pacific Islander descent.

"This work should lead us to interrogate why certain geographic areas and populations suffer a disproportionate burden of MethHF and the ways in which local public policies, differential availability of psychostimulant drugs, and socioeconomic disparities have shaped the epidemic," Parikh and colleagues wrote.

They stressed the importance of targeted interventions -- development of a pharmacotherapy for methamphetamine use disorder (MAUD), for example -- and recognition of the "competing health and life priorities relevant for this vulnerable patient population."

"We should also consider employing innovative, multidisciplinary approaches to co-manage heart failure and MAUD. For example, the development of specialty heart failure clinics that also offer contingency management -- a highly effective, evidence-based behavioral treatment for MAUD -- deserves further study and potential scale up," the editorialists wrote.

The NIS study relied on hospital records from all 50 states and captured over 12.8 million cardiomyopathy-associated hospital admissions (59.3% men, over 57% were older than 65) during the study period.

Of these admissions, 222,727 were related to methamphetamine users based on medical records (58.5% men, over 55% were ages 41-64 years). Notably, people who used methamphetamine together with other drugs were excluded from the study.

Bhuiyan's group acknowledged that the study lacked individual-level data and any postdischarge information. The authors were also uncertain how people came to be diagnosed as methamphetamine users.

"Further research is warranted to identify high-risk populations and develop strategies to prevent and mitigate CVD among methamphetamine users," they urged.

Disclosures

The study was supported by grants or awards from the National Institutes of Health and Louisiana State University.

Bhuiyan and Parikh had no disclosures.

Co-editorialists reported support from the NIDA and Chan Zuckerberg BioHub San Francisco.

Primary Source

JACC: Advances

Source Reference: opens in a new tab or windowAl-Yafeai Z, et al "Cardiomyopathy-associated hospital admissions among methamphetamine users: geographical and social disparities" JACC Adv 2024; DOI: 10.1016/j.jacadv.2024.100840.

Secondary Source

JACC: Advances

Source Reference: opens in a new tab or windowWalker SL, et al "Facing a tsunami: methamphetamine heart failure demands novel approaches" JACC Adv 2024; DOI: 10.1016/j.jacadv.2024.100838.

https://www.medpagetoday.com/cardiology/chf/109188