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Tuesday, December 12, 2023

Brain sample from Maine gunman to be examined for injury related to Army Reserves

 A tissue sample from the brain of a gunman who killed 18 people and injured 13 others in Maine has been sent to a lab in Massachusetts to be examined for signs of injury or trauma related to his service in the Army Reserves, officials said Monday.

The state’s chief medical examiner wants to know if a brain injury stemming from 40-year-old Robert Card’s military service could have contributed to unusual behavior he exhibited leading up to the Oct. 25 shootings at a bowling alley and at a bar in Lewiston .

A spokesperson for the medical examiner’s office characterized the extra step as a matter of thoroughness “due to the combined history of military experience and actions.”

“In an event such as this, people are left with more questions than answers. It is our belief that if we can conduct testing (in-house or outsourced) that may shed light on some of those answers, we have a responsibility to do that,” Lindsey Chasteen, office administrator, wrote in an email.

The gunman’s body was found two days after the shootings in a nearby town. The medical examiner already concluded that Card died by suicide.

The tissue samples, first reported by The New York Times, were sent to a laboratory at Boston University that specializes in problems associated with brain trauma, including chronic traumatic encephalopathy, or CTE, which has plagued many professional football players. A spokesperson said the CTE Center cannot comment without the family’s permission. Two family members didn’t immediately respond to a request for comment from The Associated Press.

The concerns surround Card’s exposure to repeated blasts while training U.S. Military Academy cadets about guns, anti-tank weapon and grenades at West Point, New York.

Card was assigned to the 3rd Battalion, 304th Regiment, in Saco, Maine, starting in April 2014 and during that time he trained others on how to use hand grenades, the Army said.

A Pentagon spokesperson said Monday that the Army is participating in studies to try to better understand the relationship between “blast overpressure” and brain health effects, and in the meantime it has instituted several measures to reduce soldiers’ exposure, including limiting the number of personnel near blasts.

“The Army is committed to understanding, mitigating, accurately diagnosing and promptly treating blast overpressure and its effects in all forms. While prolonged blast exposures can be potentially hazardous, even if encountered on the training range and not the battlefield, there is still a lot to learn,” Lt. Col. Rob Lodewick said in a statement.

Family members and friends reported that Card had become paranoid behavior that preceded him being hospitalized for two weeks last summer during training with fellow reservists at West Point. Among other things, Card thought others were accusing him of being a pedophile.

His fellow soldiers were concerned enough that his access to weapons was restricted when he left the hospital. At least one of the reservists specifically expressed concerns of a mass shooting.

New York and Maine both have laws that can lead to removal of weapons for someone who’s experiencing a mental health crisis, but those laws were not invoked to take his guns.

Law enforcement officials in Maine were warned about concerns from Card’s fellow reservists. But Card didn’t answer the door at his Bowdoin home when deputies attempted to check on his well-being several weeks before the shootings.

https://apnews.com/article/maine-mass-shooter-brain-sample-army-cte-17796549678fa3e402ac40daf8fdd344

USPSTF Draft Calls for Lifestyle Shift -- Not Meds -- for Kids With Obesity

 The U.S. Preventive Services Task Force (USPSTF) plans to recommend

opens in a new tab or window intensive behavioral interventions -- but not pharmacologic therapies -- for kids with a high body mass index (BMI).

In its draft recommendation statement, the task force said clinicians should provide or refer patients ages 6 years and older with a high BMI (defined as 95th or higher percentile for age and sex) to comprehensive and intensive behavioral interventions (Grade B). To reap the "moderate net benefit," kids should have 26 or more contact hours with the behavioral interventions for up to a year, they advised.

"These interventions often include education about healthy eating habits, supervised exercise sessions, and counseling and support around how to set goals and make behavioral changes," task force member John Ruiz, PhD, of the University of Arizona in Tucson, told MedPage Today. "We are hopeful that connecting kids and teens to the care they need will help them manage their weight while improving their overall health."

That said, USPSTF fell short of recommending pharmacologic therapy, citing a lack of evidence. This did not mean the group recommended against this type of treatment; however, behavioral interventions should be the primary effective intervention for kids' weight loss, the task force said.

"After a thorough review of the research, the task force did not find enough evidence to make a recommendation about weight loss medications for kids and teens at this time," Ruiz said. "That is why we're calling for more research to understand the long-term health outcomes for prescribing these medications to kids."

"What we do know is that intensive behavioral interventions consisting of 26 or more hours with a healthcare professional are effective in helping children and teens achieve a healthy weight and stay healthy," he added.

This is in contrast to the first American Academy of Pediatricsopens in a new tab or window clinical practice guideline, released in 2023, that recommended a wider array of interventions -- intensive behavioral treatment, weight-loss pharmacotherapy, metabolic surgery -- in young patients with high BMI. However, the USPSTF pointed out that its guidance is intended to be provided in, or referred from, a primary care setting, and surgical weight loss interventions are outside of that scope of practice.

When finalized, the statement will replace the 2017 USPSTF recommendationsopens in a new tab or window on screening for obesity in kids for ages 6 and older, although the current recommendations shift the focus away from screening and more on intervention. Since the 2017 recommendations, the prevalence of obesity among U.S. youth (ages 2-19 years) increased from 17% to 20%.

The USPSTF performed an evidence review of 58 randomized control trials (RCT) with nearly 9,000 individuals: 50 RCTs on behavioral interventions and eight on pharmacotherapies. For the latter, semaglutideopens in a new tab or window (-6.0 kg/m2 for 2.4 mg Wegovy) and phentermine/topiramateopens in a new tab or window (-5.4 for 15 mg/92 mg Qsymia) yielded the largest BMI reductions, while liraglutideopens in a new tab or window (-1.6 for 3 mg Saxenda) and orlistat (-0.9) were linked with smaller reductions. Semaglutide and phentermine/topiramate also improved some lipid measures, but there was "little to no improvement" in other cardiometabolic outcomes with these drugs.

Although serious side effects were rare, the GLP-1 receptor agonist pharmacotherapies (liraglutide, semaglutide) were associated with gastrointestinal side effects -- a commonly reported occurrence with this class of medication -- which led to some discontinuation. But the task force highlighted that there was no available evidence on pharmacotherapy adverse effects beyond 1 month after discontinuation or for longer than 17 months on any of the medications.

For behavioral weight management interventions, there were small BMI reductions after 6 to 12 months (on average a 0.7 drop). As expected, this BMI reduction increased as kids engaged in these interventions longer. Though the evidence was sparse for other outcomes, the systematic review found these behavioral interventions were also associated with improvements in blood pressure and fasting plasma glucose.

While there weren't really any harms to behavioral interventions, USPSTF emphasized that this type of intervention may pose an access challenge to families, as they often involve a multidisciplinary team, including pediatricians, exercise physiologists or physical therapists, dietitians or diet assistants, psychologists or social workers, or other behavioral specialists. It also takes effort from the parent and child to become educated on healthy eating, reading food labels, and engaging in exercise.

"It's important for clinicians to know that these interventions work best when both children and their parents are engaged with the intervention," said Ruiz. "We understand the challenges that intensive interventions present for families and know that young children will need extra support to make these changes."

"The task force encourages clinicians to work with children and their families to make sure that the interventions are accessible in their specific situation. Finding the right fit for each kid will help them have the best possible chance to manage their weight and stay healthy over time," he concluded.

The draft recommendation statement and draft evidence review are open for public commentopens in a new tab or window through Jan. 16, 2024.

https://www.medpagetoday.com/pediatrics/obesity/107805


'Early- and later-stage persistence with antiobesity medications: A retrospective cohort study'

 Hamlet GasoyanElizabeth R. PfohRebecca SchultePhuc Le, Michael B. Rothberg

Abstract

Objective

The study's objective was to examine the percentage of patients with an initial antiobesity medication (AOM) fill who were persistent with AOM at 3, 6, and 12 months and to characterize factors associated with persistence at 12 months.

Methods

This retrospective cohort study used electronic health records from January 2015 to July 2023 in a large health system in Ohio and Florida and included adults with BMI ≥30 kg/m2 who had an initial AOM prescription filled between 2015 and 2022.

Results

The authors identified 1911 patients with a median baseline BMI of 38 (IQR, 34–44). Over time, 44% were persistent with AOM at 3 months, 33% at 6 months, and 19% at 12 months. Across categories of AOM, the highest 1-year persistence was in patients receiving semaglutide (40%). Semaglutide (adjusted odds ratio [AOR] = 4.26, 95% CI: 3.04–6.05) was associated with higher odds of 1-year persistence, and naltrexone-bupropion (AOR = 0.68, 95% CI: 0.46–1.00) was associated with lower odds, compared with phentermine-topiramate. Among patients who were persistent at 6 months, a 1% increase in weight loss at 6 months was associated with 6% increased odds of persistence at year 1 (AOR = 1.06, 95% CI: 1.03–1.09).

Conclusions

Later-stage persistence with AOM varies considerably based on the drug and the weight loss at 6 months.

https://onlinelibrary.wiley.com/doi/10.1002/oby.23952

'Treatment Modification After Initiating Second-Line Medication for Type 2 Diabetes'

 David T. Liss, PhD

Manisha Cherupally, MS

Among adults with type 2 diabetes who started noninsulin second-line therapy, most modified treatment within 1 year. Discontinuation was by far the most common modification.

ABSTRACT

Objectives: To describe changes in antidiabetic medication (ADM) use and characteristics associated with changes in ADM use after initiation of noninsulin second-line therapy.

Study Design: Retrospective cohort study.

Methods: This study analyzed private health plan claims for adults with type 2 diabetes who initiated 1 of 5 index ADM classes: sulfonylureas, dipeptidyl peptidase 4 inhibitors (DPP4is), sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or thiazolidinediones. Analyses evaluated 3 treatment modification outcomes—discontinuation, switching, and intensification—over 12-month follow-up.

Results: Of 82,624 included adults, nearly two-thirds (63.6%) experienced any treatment modification. Discontinuation was the most common modification (38.6%), especially among patients prescribed GLP-1 RAs (50.3%). Switching occurred in 5.2% of patients and intensification in 19.8%. In adjusted analysis, compared with patients prescribed sulfonylureas, discontinuation risk was 7% higher (HR, 1.07; 95% CI, 1.04-1.10) among patients prescribed DPP4is and 28% higher (HR, 1.28; 95% CI, 1.23-1.33) among patients prescribed GLP-1 RAs. Compared with sulfonylureas, all other index ADM classes had higher risks of switching and lower risks of intensification. Younger age group and female sex were both associated with higher risks of all modifications. Compared with index ADM prescription by a family medicine or internal medicine physician, index prescription by an endocrinologist was associated with both lower discontinuation risk and higher intensification risk.

Conclusions: Most patients experienced a treatment modification within 1 year. Results highlight the need for new prescribing approaches and patient supports that can maximize medication adherence and reduce health system waste.

https://www.ajmc.com/view/treatment-modification-after-initiating-second-line-medication-for-type-2-diabetes

'Companies Market Stem Cell Treatments to Long COVID Patients'

 Clinics that sell stem cell and exosome treatments have turned their attention to long COVID patients, researchers found.

Among 38 businesses selling such treatments for COVID-19, the majority (36) marketed those therapies for long COVID, stated Leigh Turner, PhD, of the University of California Irvine, and colleagues in Stem Cell Reportsopens in a new tab or window.

"We didn't think the pattern was going to emerge as strongly as it did," Turner told MedPage Today.

Turner and his team have tracked stem cell clinicsopens in a new tab or window for years, building a database of clinicsopens in a new tab or window that operate in this arena. When the COVID-19 pandemic hit, they logged how these businesses were taking advantage of patients' fears by selling purported treatments for COVIDopens in a new tab or window.

They revisited some of those businesses last fall to see whether anything had changed as the pandemic shifted -- and lo and behold, it had.

"The pandemic has changed over time, and now there's a whole population of individuals who have had COVID-19, and they haven't completely recovered," Turner said. "They have lingering symptoms that are sometimes quite serious, sometimes life-altering" -- and that can make people desperate to find treatments, he added.

"We have a population of patients who are looking for symptomatic relief," Turner continued. "While we have long COVID clinics, people may not have an easy time getting access to them. There are long waits. And the interventions themselves may be rather limited in their effects."

That has left the door wide open for stem cell marketers to try to reach these people, Turner said.

For their study, the researchers used three strategies to find stem cell and exosome clinics marketing to COVID patients online. They looked at an earlier database of 1,480 stem cell or exosome businesses in the U.S., searched Google for additional companies both in the U.S. and abroad, and looked at businesses mentioned in Turner's 2021 Cell Stem Cell paper on companies selling stem cell treatments for COVID.

They revisited and re-analyzed all company websites in September 2022, with a final fact-check in October 2022.

Overall, they found 38 businesses that were advertising stem cell and exosome treatments for COVID, which were connected to 60 clinics.

Most of them were specifically marketing these therapies to patients with long COVID, while six businesses marketed their therapies as "immune boosters," five claimed to treat acute COVID infection, and two claimed their products could prevent COVID.

The vast majority of these businesses were based in the U.S. (40%) and Mexico (37%), while four were in Ukraine, two were in the Cayman Islands, and other countries appeared to have one business each: Guatemala, Malaysia, Panama, Philippines, Poland, Spain, Thailand, and the United Arab Emirates.

Turner and colleagues found that these products weren't cheap. Among the nine businesses that provided information on how much they charged, the least expensive product was $2,950, while the most expensive product cost $25,000. The average listed cost was $11,322, they found.

Turner said there are "plenty of things that can go wrong" when it comes to purported stem cell treatments for long COVID. These treatments are investigational and don't have scientific evidence behind them proving their success for the condition, he said.

A patient's "situation can be made dramatically worse if they're given an infusion of a product that hasn't been carefully studied or tested," Turner told MedPage Today. "There's a real possibility for serious injury in that situation, whether it's pulmonary embolism, an infection, or something else."

Indeed, many examples of stem cell treatments causing infections and other problems have been reported. The hit podcast "Bad Batch" examined an instance in which 12 people were hospitalizedopens in a new tab or window after getting contaminated stem cell injections. Nebraska health officials reported an outbreak of severe infectionsopens in a new tab or window after exosome therapies. And researchers reported on three patients who had severe vision lossopens in a new tab or window after intravitreal injections of autologous adipose tissue-derived stem cells.

There's also "an obvious possibility for financial scams," Turner said. "At an average price of $11,000, it's not like going to the store and buying some dietary supplements."

Turner said regulators should get tougher on companies peddling stem cell and exosome treatments for long COVID.

"I think it's a modest number," he said, referring to the 36 businesses his team discovered. "This seems like activity that probably deserves to be prioritized and seems like the kind of challenge the FDA and FTC [Federal Trade Commission] could actually do something about in a comprehensive way."

The FDA and FTC have pursued stem cell companies in the past, with both regulators issuing warning lettersopens in a new tab or window to such companies. One healthcare professional was even sentenced to jail timeopens in a new tab or window for selling a fake stem cell therapy.

Still, many businesses have avoided attracting regulators' attention, Turner said: "There's a lot the FDA has done, but there's still a massive marketplace."

The study was limited because it likely identified only some companies operating in this space. Also, the researchers searched only in English, and searches in other languages may reveal additional companies. In addition, businesses may have used other forms of advertising -- including billboards, newspaper or magazine ads, and radio or TV commercials -- to reach their potential customers.

"It is understandable that individuals seeking relief from shortness of breath, fatigue, 'brain fog,' heart palpitations, loss of smell, and other symptoms search for interventions that might help them," Turner and colleagues wrote. "Acknowledging the suffering and agency of such persons, members of this patient population are vulnerable to having their suffering, desperation, and hope exploited by entities making appealing therapeutic claims without having the scientific evidence needed to make such representations."

Disclosures

The project is supported by the Pew Charitable Trusts.

Turner disclosed serving as an expert witness in cases regarding unapproved stem cell treatments, as well as relationships with the International Society for Stem Cell Research and the International Society for Cell and Gene Therapy.

Primary Source

Stem Cell Reports

Source Reference: opens in a new tab or windowTurner L, et al "Businesses marketing purported stem cell treatments and exosome therapies for COVID-19: An analysis of direct-to-consumer online advertising claims" Stem Cell Rep 2023; DOI: 10.1016/j.stemcr.2023.09.015.


https://www.medpagetoday.com/special-reports/features/107822

'5 Companies Sign Agreement to Participate in National Health Data-Sharing Network'

 Five healthcare companies took another step toward becoming part of a nationwide network to exchange patient health information on Tuesday.

"I feel like we're watching the Big Bang occur in 2023," HHS Secretary Xavier Becerra said during an event held at HHS headquarters here. He congratulated "the entities who stepped up early to help us bring together everyone and are now going to help share -- on a platform that most people would say would never happen, yet it's open, it's available; it's a private-public partnership bringing together experienced, established, and new players who know how to make sure that we are working with the interoperable healthcare information system, kudos to you. You are those big universes that are establishing themselves as the light in the sky. It is great to see you come forward."

The five companies -- eHealth Exchange, Epic Nexus, Health Gorilla, KONZA, and MedAllies -- became the first qualified health information networks (QHINs) to meet the criteria for participating in the Trusted Exchange Framework and Common Agreement (TEFCA), a network the federal government is building to make it easier for health plans, providers, public health agencies, and patients to exchange health information. Executives from the companies all participated in a signing ceremony on Tuesday.

As to when operations will actually begin, "Common Agreement Version 2.0 ... is actively under development and scheduled to be adopted by the QHINs within the first quarter of 2024," according to a press releaseopens in a new tab or window from the Office of the National Coordinator for Health Information Technology (ONC).

"A complete and accurate medical record is essential to high-quality care," said Rob Klootwyk, director of interoperability for Epic Nexus, in Verona, Wisconsin. "When clinicians can easily exchange information, they can see the full medical history of their patients and provide the best care. TEFCA is bringing clarity to this country by aligning all the regional efforts under a federally enforced Big Bang ... But there are still gaps in us achieving that universal interoperability, and collectively, we all need to continue those efforts to close those gaps by engaging every physician in this country to become a participant in TEFCA."

"For them, that will be the single on-ramp to nationwide interoperability," he continued. "As of this week, over 200 hospitals and 3,000 clinics that use Epic plan to be early adopters of this framework ... At full rollout we do expect to help around 2,700 hospitals and 70,000 clinics to go live on TEFCA. And to me, a critical mass of providers adopting TEFCA as soon as possible is the key to TEFCA's success. So, I'm excited for the day when every provider in this country can answer the question 'Are you part of TEFCA?' with a resounding 'Yes.'"

image
Getting the first few companies to sign on to the data-sharing agreement feels "like watching the Big Bang," said HHS Secretary Xavier Becerra. (Photo by Joyce Frieden)

ONC head Micky Tripathi, PhD, MPP, also urged providers to come on board, saying that forward movement on TEFCA "will hopefully allow all of those who are on the sidelines, the HIEs [health information exchanges] who aren't getting connected up with each other, the vendors who haven't yet joined, and the physicians and smaller hospitals who weren't aware that this is going on, or don't have the resources or haven't made it a priority ... Hopefully, this will give them all the clarity to say, 'Yeah, I need to do that thing.'"

One thing the common agreement doesn't include is a unique patient identifier for each patient whose data is being shared. Tripathi told MedPage Today that he didn't think that would be an issue. "It certainly would be helpful, but it's not required," he said in a brief interview, adding that because Congress has long prohibited establishment of such an identifier, "the industry has just had to adapt. It's certainly a fair question to say 'Would it improve things?' but I'd just say it's not necessary because we've done so much other work" in terms of patient identification.

https://www.medpagetoday.com/practicemanagement/informationtechnology/107823

'Metformin for Diabetes in Pregnancy: Maybe Not, Trial Says'

 Adding metformin to insulin treatment for pregnant women with preexisting type 2 or gestational diabetes did not reduce composite neonatal adverse outcomes, according to the randomized MOMPOD trial.

The composite outcome -- encompassing perinatal death, preterm birth, large or small for gestational age, and hyperbilirubinemia requiring phototherapy -- occurred at similar rates in the metformin and placebo groups (71% vs 74%, adjusted OR 0.86, 95% CI 0.63-1.19).

However, metformin was associated with fewer large-for-gestational-age infants (26% vs 36%, OR 0.63, 95% CI 0.46-0.86), reported Kim Boggess, MD, of the University of North Carolina at Chapel Hill, and co-authors in JAMAopens in a new tab or window.

The difference in birthweight was around 180 g, but this reduction did not translate into fewer operative deliveries in the metformin group, Boggess noted in an interview with MedPage Today.

"In the case of patients with type 2 diabetes, we knew that based on established evidence that glycemic control is critical to improving ... both maternal and infant outcomes," Boggess said. "But we didn't really know the best way to achieve maternal glycemic control."

Guidelines recommend insulin as first-line pharmacotherapy for preexisting type 2 diabetes, and metformin for patients who cannot use insulin or decline to do so.

MOMPOD's findings counter those of the prior MiTy trialopens in a new tab or window, conducted in Canada and Australia, that found metformin improved maternal glycemic control and resulted in less maternal weight gain, less neonatal adiposity, fewer cesarean deliveries, and more small-for-gestational-age neonates.

In an accompanying editorialopens in a new tab or window, MiTy investigator Denice Feig, MD, of the University of Toronto, put the findings together: "The results of MOMPOD suggest that although still useful in reducing births of large-for-gestational-age infants and improving glycemic control, other benefits of metformin use in those with type 2 diabetes during pregnancy may be diminished in some populations."

Third-trimester hemoglobin A1c was 5.97% with metformin versus 6.22% with placebo, but the difference was of borderline significance (geometric mean ratio 0.96, 95% CI 0.93-1.00) and it was measured in only 39% of trial participants.

Feig and Boggess both noted that the differences between trial findings should be further investigated. Boggess said her team is working on combining the data from MiTy and MOMPOD trials for an individual patient meta-analysis. They're also hoping to see whether there are positive or negative infant effects into childhood.

MOMPODopens in a new tab or window was a 17-site, double-blinded randomized clinical trial. From June 2017 to November 2021, participants were enrolled in the study, with a pause April-September 2020 because of the pandemic. All final visits were complete by May 2022.

The cohort included adults ages 18 to 45 who had a singleton pregnancy of 10 to 22 weeks, 6 days gestation at baseline; all had preexisting type 2 diabetes requiring insulin or had diabetes diagnosed by 23 weeks gestation. The 794 participants were randomized 1:1 to receive insulin plus 1,000 mg metformin or insulin plus placebo.

Participants identified their heritage as 52% Hispanic, 29% Black, 14% white, and 3% Asian. The mean age was 32.9 years. Most had preexisting type 2 diabetes (78%), and the rest were diagnosed early in pregnancy (21%).

Preterm birth, neonatal hypoglycemia, and delivery of a large-for-gestational-age infant were the most common primary outcome in both groups. Among adverse events, both groups experienced nausea and vomiting at similar rates, but the metformin group reported higher instances of diarrhea (28 vs 12%, P<0.01).

The study was stopped at 75% of planned enrollment because of futility, which in combination with the pandemic-related pause, limited the measurability of metformin's impact on less common outcomes. Authors also noted that results were similar across BMI subgroup analyses, but those with obese BMIs were overrepresented in the metformin group. Poor adherence might have been underreported, since it was measured by self-report.

Disclosures

This study was funded by a grant from the NICHD and the University of North Carolina Department of Obstetrics and Gynecology.

Study authors reported receiving grants from the NIH, the University of North Carolina, Novo Nordisk, Eli Lilly, Sanofi, vTv Therapeutics, Dexcom, Boehringer Ingelheim, and NICHD.

Feig reported receiving grants from the Canadian Institute for Health Research, personal fees from Novo Nordisk, and nonfinancial support from Apotex.

Primary Source

JAMA

Source Reference: opens in a new tab or windowBoggess KA, et al "Metformin plus insulin for preexisting diabetes or gestational diabetes in early pregnancy: the MOMPOD randomized clinical trial" JAMA 2023; DOI:10.1001/jama.2023.22949.

Secondary Source

JAMA

Source Reference: opens in a new tab or windowFeig DS "Metformin for diabetes in pregnancy: are we closer to defining its role?" JAMA 2023; DOI: 10.1001/jama.2023.18589.


https://www.medpagetoday.com/obgyn/pregnancy/107802