Vaccine Injury Claims Are Rare

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NY Times: Vaccine Injury Claims Are Few and Far Between

An excerpt:

The data comes from the National Vaccine Injury Compensation Program, a no-fault system begun in 1988 after federal law established it as the place where claims of harm from vaccines must be filed and evaluated. It currently covers claims related to 15 childhood vaccines and the seasonal flu shot.

Over the past three decades, when billions of doses of vaccines have been given to hundreds of millions of Americans, the program has compensated about 6,600 people for harm they claimed was caused by vaccines. About 70 percent of the awards have been settlements in cases in which program officials did not find sufficient evidence that vaccines were at fault…

The Centers for Disease Control and Prevention has estimated that vaccines prevented more than 21 million hospitalizations and 732,000 deaths among children over a 20-year period….

There were about two claims of injury for every one million doses of all vaccines distributed in the United States from 2006 through 2017, the period for which the injury compensation program has dosage data. It says more than 3.4 billion vaccine doses were distributed during that time.

The rarity of claims is especially notable because the program aims to make it easy to file a petition…

A growing proportion of recent claims, about half of all petitions since 2017, do not involve the content of vaccines themselves. Instead, they refer to shoulder injuries, usually in adults, that occurred because a health provider injected a vaccine too high on the shoulder, or into the joint space instead of into muscle tissue. That may cause an inflammatory response leading to shoulder pain and limited motion.

My take (from Paul Offit, MD): “The most dangerous aspect of giving your child vaccines is driving to the office to get them.”

Related blog posts:

Do Anti-TNF Agents Reduce Surgeries and Hospitalizations?

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Briefly noted:

A recent study (http://dx.doi.org/10.1136/gutjnl-2019-318440; SK Murthy et al. BMJ indicates that anti-TNF therapy has not been effective in significantly lowering CD-related hospitalizations or surgeries.

Full Text Link (from Eric Benchimol twitter feed): Introduction of anti-TNF therapy has not yielded expected declines in hospitalisation and intestinal resection rates in inflammatory bowel diseases: a population-based interrupted time series study)

My take: While big changes in the frequency of these outcomes were not demonstrated in this large study, prior studies, including the RISK study, have shown that anti-TNF therapy can be disease-modifying and reduce the risk of penetrating disease in Crohn’s disease.

Related blog post: CCFA Updates in IBD

 

Gun Carrying Adolescents –Why We Are Going to See More School Shootings

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A recent cross-sectional study (RMC Kagawa et al. J Pediatr 2019; 209: 198-203) shows a high rate of gun carrying among adolescents in the U.S.

Key findings:

  • Based on a sample of 10,112 adolescent who completed surveys, 2.4% of adolescents reported carrying a gun in the prior 30 days.
  • Carrying a gun was more common among adolescents with a conduct disorder (adjusted prevalence ratio 1.88), drug use disorders (APR 1.91) and patients with specific phobias (APR 1.54)
  • The authors estimate that 1.1% of adolescents with a disorder associated with self- or other-directed violence also carry guns.  This extrapolates to 272,000 adolescents with both risk factors.
  • Nearly two-thirds of adolescents who report gun carrying had a mental health disorder

My take:

  1. Guns are everywhere.  Gun carrying among adolescents, while only a small percentage of all adolescents, represent a grave risk; especially, since the majority who report carrying guns (in this study) have mental health issues.
  2. Safe storage needs to be a requirement of gun ownership.  Gun access and misuse by adolescents is a ‘clear and present danger’ (apologies to Tom Clancy).

Related blog posts:

El Retiro Park, Madrid

Early Psychosocial Environment and Cardiometabolic Risk

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“It is easier to build strong children that to repair broken men”

-Frederick Douglass

This quote comes from a previous lecture on adverse childhood experiences (ACEs) and comes to mind after reading a recent study: JR Doom et al. J Pediatr 2019; 209; 85-91.

This study examined 588 adolescents (16-18 yrs) from a longitudinal cohort that began in infancy (in Chile).

Methods: Psychosocial environmental factors including depressive symptoms, stressful life events, poor support for child development, father absence, and socioeconomic status was reported by mothers at 6-12 months of age.  These factors were analyzed to determine association with adolescent cardiometabolic parameters including BMI, higher blood pressure, anthropometric risk factors for cardiovascular disease, biomarkers for cardiovascular disease (e.g. triglycerides, HOMA, cholesterol) and metabolic syndrome

Key findings:

  • Infants with poor psychosocial environments had higher BMIs at 10 years and in adolescence, higher blood pressures, greater anthropometric risk, worsened cardiovascular biomarkers, and higher likelihood of metabolic syndrome (aOR 1.5)
  • The Figure in the article shows sequential worsening by quartiles -those with the highest risk based on psychosocial stress composite were worse on these outcomes compared to the 2nd highest risk factor quartile group. And in turn, the 2nd highest risk group >3rd highest risk group >lowest quartile.
  • “It is unknown whether these associations may be reversible.”

My take: While these results show a clear association of early life factors and worsened cardiovascular/metabolic outcomes, the mechanism for this is unclear.  Is this related to diet, less physical activity, stress hormones, a combination or other factors?

Related blog post:

How Often is Arthritis a Presenting Feature of Pediatric IBD & How to Make the Right Diagnosis

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A recent retrospective study (R Levy et al. J Pediatr 2019; 209: 233-5) analyzed the musculoskeletal presenting manifestations of pediatric inflammatory bowel disease (IBD).

In their cohort of 715 patients with IBD, 137 had arthritis and/or arthralgia.  28 of these 137 patients (3.9% of total cohort) had arthritis preceding the diagnosis of IBD and were eligible for this study.  Only 23 had complete data and were compared with 46 children with arthritis due to JIA (n=21), FMF (n=7), and postinfectious arthritis (n=18).

Key findings:

  • Patients with subsequent IBD diagnosis were more likely to have sacroiliac involvement (34.8% vs. 2.2%), more likely to have anemia (mean hgb 10.5 vs 12), more likely to have low albumin (mean 3.5 vs 4.3) and to have higher inflammatory markers (ESR 81 vs 46; CRP 6.6 vs 4.5 mg/dL)
  • In patients with calprotectin levels, 5 of 6 were >300 mg/kg and one was borderline
  • On direct questioning at time of IBD diagnosis, prolonged gastrointestinal symptoms (e.g. abdominal pain, diarrhea, weight loss, aphthous ulcers) were evident in 78%.
  • 4 of the 23 (17.3%) were diagnosed with IBD during the primary investigation. Ultimately, Crohn’s diagnosis was established in 87% of the IBD group.

My take: This study is important for pediatricians and rheumatologists. ~4% of children presenting with arthritis have IBD.  Careful interrogation for GI symptoms (and perianal exam) will avoid diagnostic delay in most patients as would a stool calprotectin. Features like sacroileitis, and abnormal labs should also increase the suspicion for IBD.

Briefly noted: In a study discussing pediatrician beliefs about JIA (MR Pavo, J de Inocencio, J Pediatr 2019; 209: 236-9) there is an important caveat for GI doctors:

“It is clear that booster vaccinations against measles, mumps, rubella, or varicella zoster virus, can be considered in patients receiving < 15 mg/m-squared/week of MTX [methotrexate]”  (Pediatr Rheumatol Online J 2018; 16: 46).

Related blog post:

  • IBD Update Feb 2019 -last entry shows study indicating that patients with IBD and arthritis were more likely to require biologics.

Calprotectin:

El Retiro Park, Madrid

 

Good Nutrition News in Our Schools –Why Not a Press Release?

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Washington Post: Why is the USDA downplaying good news

An excerpt:

The best news was that the Healthy Eating Index (HEI-2010), a multicomponent measure of diet quality, shot up dramatically for both school-provided breakfasts and lunches.

For the 2009-2010 school year, the score for breakfast was an abysmal 49.6 out of 100 (even lower than the overall American average of 59), rising to 71.3 by the 2014-2015 school year. In that same time frame, the lunch score went from 57.9 to 81.5. The score for whole grains in school meals went from 25 to 95 percent of the maximum score, and the score for greens and beans rose from 21 to 72 percent.

In addition, there was greater participation in school meal programs at schools with the highest healthy food standards. And the study found food waste, a troubling national problem in the lunchroom, remained relatively unchanged.

The 52-page summary of study findings is chockablock with other good news, so why isn’t Agriculture Secretary Sonny Perdue crowing about it?…

In December, Perdue announced the USDA was weakening school nutrition standards for whole grain, nonfat milk and sodium, all of which had been tightened during the Obama administration. He cited food waste and nonparticipation as key rationales for the shift

 

How Does the U.S Compare to African Nations in HIV Treatment?

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A recent commentary (WM El-Sadr et al. NEJM 2019; 380; 1985-7) shows how poorly we are doing in our efforts to diagnose and treat HIV in this country and what we need to do to make progress in eliminating HIV.

Overall, the U.S. overall viral suppression rate, which is the percentage of all people with HIV in whom the virus is suppressed, is only 51%.  In contrast, the rates for Nambia, Uganda, and Zambia are 75%, 55%, and 50% respectively (U.S. measures use slightly different denominators than other countries.)

From NEJM twitter feed: AIDS in America –Back in the Headlines at Long Last

Link to Podcast: Ending the U.S. HIV Epidemic

Ursodeoxycholic Acid in Pediatric Primary Sclerosing Cholangitis

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A large retrospective study (M Deneau, M Perito, A Ricciuto, N Gupta et al. J Pediatr 2019; 209: 92-6) examined the outcomes/response of ursodeoxycholic acid (UDCA) for pediatric primary sclerosing cholangitis (PSC).

Background:

  • “Within 10 years of diagnosis, 30% of children with PSC will require liver transplantation and 50% of children will develop complications, including biliary strictures and hypertension.”
  • Because UDCA has not been shown to improve survival (& may worsen outcomes), it is not recommended in adults by the AASLD.
  • In pediatrics, UDCA remains the most common treatment, used in more that 80% on long-term treatment

Study population/methods:

  • 263 patients at 46 centers
  • Median age 12.1 years
  • UDCA median dose: 15 mg/kg/day

Key findings:

  • Normalization of GGT (<50 IU/L) occurred in 46% of patients in the first year after diagnosis
  • Patients with normalization was less likely among patients with Crohn’s disease and those with laboratory profiles indicative of more advanced hepatobiliary fibrosis (eg. lower platelet count, lower albumin, hyperbilirubinemia)
  • The 5-year survival with native liver was 99% in those who achieved normalization vs 77% in those who did not
  • Even in those without normalization, improvement in GGT was associated with better outcomes. “Those who had a reduction in GGT of >75% had nearly the same long-term survival as those with GGT<50 IU/L at 1 year.”
  • It has previously been shown that nearly “one-third of children who are UDCA-naive have spontaneous GGT normalization by 1 year.”  Thus, the number to treat with UDCA to have one additional case of GGT normalization is four.
  • In a previous study, one-third of patients with GGT normalization on UDCA therapy for 1 year, maintained GGT <29 after withdrawal of UDCA for 12 weeks.

The authors note that “patients who do not achieve normalization could reasonably stop UDCA as they are likely not receiving clinical benefit.”

My take: This study shows that patients who have improvement/normalization of GGT with UDCA therapy have improved outcomes.  The retrospective design of the study limits conclusions about whether UDCA therapy actually improves long-term outcomes, particularly since UDCA at higher doses has been associated with detrimental affects in adults with PSC.

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Pablo Picasso, Le Compotier (Fruit Bowl) at Sofia Reina
https://www.museoreinasofia.es/en/collection/artwork/compotier-fruit-bowl

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications/diets (along with potential adverse effects) should be confirmed by prescribing physician/nutritionist.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.