Outcome of Zen Magnets v. Consumer Product Safety Commission

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PT Reeves, B Rudolph, CM Nylund. JPGN 2020; 71:699-703. Magnet Ingestions in Children Presenting to Emergency Departments in the United States 2009–2019: A Problem in Flux

When the 10th Circuit Court, with judges Gorsuch, Ebel, and Bacharah, rolled back high-powered magnet regulations in 2016, it was expected that this would result in more suffering in children. The referenced article by Reeves et al documents the effects of this decision.

Background: In 2016, the Zen Magnets decision resulted in magnets returning to the market with warning labels “but not performance standards favored by NASPGHAN (ie, making magnets either too large to swallow or too weak to cause harm).” In this study, the authors used data from the National Electronic Injury Surveillance System (NEISS), a database of consumer product injuries.

Key findings:

  • When stratified by time period, suspected magnet ingestion (SMI)per year was 1598 during off-market period (when product was banned) compared with 2826 during on-market period.
  • An estimated 23,756 children (59% males, 42% < 5 years old) presented with a SMI from 2009 to 2019.
  • There was an average annual case increase of 6.1% (P = 0.01).
  •  After 2017, there was a 5-fold increase in the escalation of care for multiple magnet ingestions (estimated n = 1094; CI 505–1686). “Escalation of care” refers to cases designated as ‘treated and transferred,’ ‘treated and admitted/hospitalized,’ or ‘held for observation.’
  • More data on this topic from CPSC 124 page report: (Link) Informational Briefing Package Regarding Magnet Sets

My take: Regulatory action is needed to prevent harm in children from these high-powered magnets.There are two companion bills in Congress which are in committee, one entitled “Magnet Injury Prevention Act.” These are clearly needed given previous judicial branch ruling.

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Study Confirms High COVID Risk for Healthcare & Essential Workers

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M Mutambudzi et al. BMJ 2020 Free Full Text: Occupation and risk of severe COVID-19: prospective cohort study of 120 075 UK Biobank participants 

Using UK Biobank data with 120 075 participants with 271 who had severe COVID-19, key findings:

  • Relative to non-essential workers, healthcare workers (RR 7.43, 95% CI 5.52 to 10.00), social and education workers (RR 1.84, 95% CI 1.21 to 2.82) and other essential workers (RR 1.60, 95% CI 1.05 to 2.45) had a higher risk of severe COVID-19.
  • More specifically, healthcare professionals (doctors, psychologists, pharmacists) (RR 6.19, 95% CI 3.68 to 10.43). The higher risk of severe COVID-19 among healthcare workers was not reduced after adjustment for socioeconomic, work-related, or health and lifestyle-related factors
  • Using more detailed groupings, medical support staff (RR 8.70, 95% CI 4.87 to 15.55), social care (RR 2.46, 95% CI 1.47 to 4.14) and transport workers (RR 2.20, 95% CI 1.21 to 4.00) had the highest risk within the broader groups.
  • Compared with white non-essential workers, non-white non-essential workers had a higher risk (RR 3.27, 95% CI 1.90 to 5.62) and non-white essential workers had the highest risk (RR 8.34, 95% CI 5.17 to 13.47).

My take: This study shows the increased risk of severe COVID-19 among essential workers, particularly in healthcare field and non-white ethnicity was associated with further increased risk.

Wildfires and Human Health

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R Xu et al. NEJM 2020; 383: 2173-2181. Full Text: Wildfires, Global Climate Change, and Human Health

This article describes the worsening situation with global wildfires and their direct/indirect effects on human health. In addition, “the interplay between wildfires and climate change is likely to form a reinforcing feedback loop, making wildfires and their health consequences increasingly severe.” The authors conclude that “societal action is requisite… to limit the global temperature increase” and reduce the severity of wildfires and other effects of climate change.

Specific health risks:

  • Direct health effects include burns, injuries, mental health effects, and death due to exposure to flames or radiant heat
  • There is consistent evidence of an increased risk of respiratory events, including hospitalizations and emergency department visits due to asthma, chronic obstructive pulmonary disease, and respiratory infection.
  • Heavy smoke can cause eye irritation and corneal abrasions and can substantially reduce visibility, increasing the risk of traffic accidents.
  • Owing to traumatic experiences, property loss, and displacement, residents in areas affected by wildfires are at an increased risk for mental illness, including post-traumatic stress disorder, depression, and insomnia. The psychological consequences of wildfire events can persist for years, and children and adolescents are particularly vulnerable.
  • Risks of low birth weight and preterm birth are increased

Related article: NY Times (11/29/20): Wildfire Smoke Is Poisoning California’s Kids. Some Pay a Higher Price.

“The fires sweeping across millions of acres in California aren’t just incinerating trees and houses. They’re also filling the lungs of California’s children with smoke, with potentially grave effects over the course of their lives.” This article goes on to detail the personal effects of wildfires on 5 families.

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Sunset from Sullivan’s Island, SC

“Real-world” Efficacy for Fecal Microbiota Transplantation

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CR Kelly et al. Gastroenterol 2020; doi.org/10.1053/j.gastro.2020.09.038 (in press). Fecal Microbiota Transplantation Is Highly Effective in Real-World Practice: Initial Results From the FMT National Registry

Background: “The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers.” n=259 with 222 who completed short-term follow-up.

Key findings:

  • All FMTs were done for CDI and 249 (96%) used an unknown donor (eg, stool bank).
  • 90% (n=200) were considered cured at one month. Of these, 197 (98%) received only 1 FMT.
  • Among 112 patients with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence.
  • Safety:  Severe symptoms reported within 1-month of FMT included diarrhea (n = 5 [2%]) and abdominal pain (n = 4 [2%]); 3 patients (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 patients (1%) and inflammatory bowel disease in 2 patients (1%). Milder adverse events were noted in 45% with symptoms including diarrhea, abdominal pain, bloating or constipation.

My take: Overall, the findings from this prospective registry confirm that FMT works fairly well for CDI. Long-term follow-up will provide more answers on the safety of FMT.

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Budesonide for Maintaining EoE Remission

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A Straumann et al. Gastroenterology 2020; Free Full Text Link: Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis

Methods: Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given budesonide orodispersible tablet (BOT) 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks

Key Findings:

  • At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo)
  • Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment

In the discussion, the authors state that “we recommend monitoring symptoms and signs of adrenal insufficiency when administrating topical-acting corticosteroids over prolonged time periods, in particular in children and when using higher dosages.”

My take (from discussion): “EoE requires a proper long-term anti-inflammatory therapy because, without active treatment, the vast majority of patients experience a relapse within the first 100 days after cessation of the medication.”

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A Path Forward for Microvillous Inclusion Disease?

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I Kaji et al. Gastroenterol 2020; 159: 1390-1405. Full free text: Lysophosphatidic Acid Increases Maturation of Brush Borders and SGLT1 Activity in MYO5B-deficient Mice, a Model of Microvillus Inclusion Disease

Key finding: Lysophosphatidic acid (LPA)partially restored the brush border height and the localization of SGLT1 and NHE3 in small intestine of MYO5B-knockout mice and enteroids. There are a number of high quality figures that illustrate these effects:

From Figure 1. Changes in  jejunal morphologies by MYO5B deletion and administration of LPA

Editorial, S Abtahi, JR Turner. Gastroenterol 2020; 159:1233-1235: Full free text: Exploiting Alternative Brush Border Trafficking Routes to Treat Microvillous Inclusion Disease

Background (from editorial):

  • Small bowel biopsies in MVID include enterocytes that have either sparse, blunted microvilli or lack microvilli completely. Large cytoplasmic inclusions with prominent luminal microvilli are, however, present along with increased numbers of subapical lysosomes and other small vesicles
  • Biochemically, brush border expression of the Na+-glucose cotransporter SGLT1 (Slc5a1), the N+-H+ exchanger NHE3 (Slc9a3), and aquaporin 7 are markedly decreased in patients with MVID
  • Myo5b knockout in mice induces histopathologic and clinical features of MVID, including villous blunting, growth failure, and increased stool water, that is, diarrhea
  • Previous studies have shown that NHE3 trafficking from the apical storage pool to the brush border could be triggered by lysophosphatidic acid (LPA)

Key points from editorial

  • Kaji et al treated adult Myo5bf/f x vil-CreERT2 mice with …oral or systemic LPA administration. Villous blunting, microvillous loss, and apical lysosomal expansion were substantially reversed after 4 days of systemic LPA treatment
  • Although the morphologic and physiologic responses induced by LPA are striking, the weight loss that began within 2 days of Myo5b knockout was not attenuated. Thus, despite being remarkably beneficial when assessed using laboratory assays, LPA has not yet been shown to be an effective therapeutic agent.

My take (borrowed from editorial): This study shows “there are multiple trafficking pathways to the brush border and that one of these can be exploited to overcome defects in another.”

Disease Activity, Not Medications, Linked to Neonatal Outcomes Among Women with IBD

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U Mahadevan at el. Gastroenterology; 2020: (in press) DOI:https://doi.org/10.1053/j.gastro.2020.11.038. Pregnancy and Neonatal Outcomes after Fetal Exposure To Biologics and Thiopurines among Women with Inflammatory Bowel Disease

Methods: Between 2007 and 2019, pregnant women with IBD were enrolled in a prospective, observational, multicenter study across the United States (PIANO registry). 

Key findings:

  • Exposure was to thiopurines (242), biologics (642) or both (227) versus unexposed (379)
  • Medication exposure did not increase the rate of congenital malformations, spontaneous abortions, preterm birth, LBW, and infections over the first year of life
  • Higher disease activity was associated with risk of spontaneous abortion (HR 3.41, 95% CI 1.51-7.69) and preterm birth with increased infant infection (OR 1.73, 95% CI 1.19-2.51)

My take: This study provides some reassurance that treatments for IBD are unlikely to affect neonatal outcomes; however, increased IBD activity does affect outcomes

Related blog post: IBD and Pregnancy

Expert Update on COVID-19 Pandemic and Vaccine Rollout

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Our hospital system has been arranging frequent staff meetings to provide situational updates amid the pandemic. On 12/2/20, Evan Anderson (infectious disease) provided an ​an excellent update on COVID-19​/rollout of vaccines.

Key Points:

  • mRNA vaccines​ have been remarkably effective, both ~95% and also effective against severe disease (>90%)
  • Severe reactogenicity occurs >2%. Systemic symptoms like fatigue, myalgia, and chills are more common after 2nd dose
  • Local reactions are typically more pronounced than flu vaccine but less pronounced compared to shingles vaccine (Shingrix)
  • Not wise to vaccinate entire care areas at same time
  • No need to check antibody titers after vaccination
  • Current contraindications: Pregnant women and children due to lack of data (Pfizer vaccine may be approved for those older than 12 yrs)
  • Study participants were allowed to take antipyretics
Slides used with permission.

Current pandemic situation in metro Atlanta (slide from Dan Salinas)

Top curve is total cases and bottom curve is ICU beds –both thru 11/27/20

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“Best Practice Advice” for Small Intestinal Bacterial Overgrowth– ????

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EMM Quigley, JA Murray, M Pimental. Gastroenterol 2020; 159: 1526-1532. Clinical Practice Guidelines. Full Free Text: AGA Clinical Practice Update on Small Intestinal Bacterial Overgrowth: Expert Review

This is a really lousy clinical practice guideline but a pretty good review of small intestinal bacterial overgrowth (SIBO). The reason why it is lousy: it provides virtually no recommendations on how to define/diagnose SIBO, does not recommend specific testing and equivocates on specific treatments.

Here are a few of the “best practice advice” as examples:

  • #1 The definition of SIBO as a clinical entity lacks precision and consistency; it is a term generally applied to a clinical disorder where symptoms, clinical signs, and/or laboratory abnormalities are attributed to changes in the numbers of bacteria or in the composition of the bacterial population in the small intestine
  • #5 A major impediment to our ability to accurately define SIBO is our limited understanding of normal small intestinal microbial populations
  • #6 Controversy remains concerning the role of SIBO in the pathogenesis of common functional symptoms, such as those regarded as components of irritable bowel syndrome
  • #9 There is a limited database to guide the clinician in developing antibiotic strategies for SIBO

While not providing ‘best practical advice,’ the article does provide details regarding limitations in testing, underlying pathogenesis, and potential treatment regimens for adults.

Table 3 -Provides Some Takeaway Points

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