Category Archives: Pediatrics

Measles, Seizures and Sometimes Death due to Vaccine Delays and Avoidance

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Three recent news items provide more up-to-date reasons for childhood vaccines.

1. Delaying vaccines may increase seizures –here’s the link and an excerpt (from NY Times):

“Some parents postpone their children’s vaccinations because they believe the delay decreases the risk. But a new study finds the opposite may be true.

The analysis, published online in Pediatrics, involved 5,496 children born from 2004 to 2008 who had seizures in the first two years of life.

For children who received any of their shots as recommended before age 1, there was no difference in the incidence of seizure in the 10 days after vaccination compared with the period before vaccination. But compared with giving it in the first year, giving the measles-mumps-rubella vaccine at 16 months doubled the incidence of seizure, and giving the measles-mumps-rubella-varicella vaccine at that age increased it almost six times.”

 

2. Rate of measles infections at 20 year high –here’s the link and an excerpt: (from USA Today)

“The USA has the most measles cases in 20 years…The confirmed case count for 2014, as of May 23, was 288 and growing, the CDC says. That number includes 138 cases from Ohio, where the biggest outbreak is ongoing – and where the actual count is 166 as of Thursday, according to the state Health Department.

The nationwide total is the highest for late May since 1994, when 764 cases were reported, the CDC says. It surpasses the 220 cases reported in all of 2011, which was the most in the post-2000 era.

“This is not the kind of record we want to break, but should be a wake-up call for travelers and for parents to make sure vaccination records are up to date,” said Anne Schuchat, director of the CDC’s National Center for Immunizations and Respiratory Diseases. Schuchat…Before the measles vaccine became available in 1963, the virus infected about 500,000 Americans a year, causing 500 deaths and 48,000 hospitalizations.

Cases this year have been reported in 18 states and New York City. Ninety percent have been among people who have not been vaccinated or have unknown vaccination status, according to the CDC. Most of the patients report religious, philosophical or personal reasons for avoiding vaccines.”

 

3. When parents withhold vaccines, vulnerable children get sick and sometimes die  –here’s the link (reference noted from Eric Benchimol’s twitter feed) and an excerpt:

“Jason Lawson recalled a terrifying 10 days in B.C. Children’s Hospital when his son Beckett was six, after Beckett became severely ill from chicken pox.

At the time, Beckett was still receiving a maintenance dose of chemotherapy to kill potential cancer cells. That treatment also suppressed Beckett’s immune system.

When an unvaccinated child at the school passed on chicken pox, the consequences were dire — at one point the virus got into Beckett’s liver and started to do damage, which in some cases can be irreversible….

Lawson said he’s speaking out to remind families that protecting their friends and neighbours is another good reason to make the effort.“

Take home message:  With every medical intervention, there are risks and benefits.  Those who forego vaccines increase the risk for themselves, their families and friends.

Related blog posts:

 

 

Facts and Fiction with Lyme Disease and Picture of the Deadliest Animal

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Since summer is around the corner, a recent article on Lyme disease may be of interest.  This clinical practice article on Lyme disease opens w/ case, reviews tx strategies & guidelines, ends w/ recommendations. Here’s a link to the article: 

Lyme disease is caused mainly by the spirochete Borrelia burgdorferi (and other related species outside of U.S.).  Pediatric gastroenterologists sometimes are asked to evaluate children with persistent symptoms attributed to Lyme disease.  This expert review makes a few key points:

  • Erythema migrans lesions often do not have central clearing; the majority are uniformly erythematous or have enhanced central erythema (pictures noted in Figure 1).  A useful differential diagnosis is noted in Table 2.
  • Antibody testing is not indicated routinely in patients with erythema migraines due to poor sensitivity in early infections.
  • Treatments are highly effective –mainly doxycycline, amoxicillin or cefuroxime
  • Prophylactic treatment with doxycycline can reduce risk of infection after tick bite, but usually not given.  “Even in areas where Lyme disease is highly endemic, the risk of disease transmission from a recognized bite is low (1 to 3%).”
  • “There is no evidence that patients treated for Lyme disease who have persistent, nonspecific symptoms (eg. arthralgia and fatigue) have persistent infection; the risks of prolonged treatment with antimicrobial agents far outweigh the benefit, if any.”
  • There is “extensive publicity as well as misinformation on the Internet about ‘chronic’ Lyme disease, a condition for which there is no clear definition or scientific evidence of its existence.”

My two cents: ‘an ounce of prevention is worth a pound of cure.’  If spending a lot of time outdoors, consider applying topical insecticides like DEET and/or wearing long sleeves/pants.

More important globally than Lyme disease is the deadliest animal in the world (from Bill Gates), http://b-gat.es/1kjGmpL :

Which animal kills the most people? Hint: It’s not sharks, lions, or even humans. Introducing Mosquito Week.

Parental Immunity (to Education) and Vaccine Decision-Making

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A recent NY Times editorial by the lead author of a provocative study in Pediatrics (Published online March 3, 2014  (doi: 10.1542/peds.2013-2365) argues that educational efforts to inform parents may not improve vaccination rates in children.

Here’s a link: http://nyti.ms/1sq4X2s  and here’s an excerpt:

“we found that parents with mixed or negative feelings toward vaccines actually became less likely to say they would vaccinate a future child after receiving information debunking the myth that vaccines cause autism.

Surprising as this may seem, our finding is consistent with a great deal of research on how people react to their beliefs being challenged. People frequently resist information that contradicts their views, such as corrective information— for example, by bringing to mind reasons to maintain their belief — and in some cases actually end up believing it more strongly as a result….

A more promising approach would require parents to consult with their health care provider, as the Oregon law also allows them to do. Parents name their children’s doctor as their most trusted source of vaccine information. That trust might allow doctors to do what evidence alone cannot: persuade parents to protect their children as well as yours and mine.

Related blog posts:

Therapeutic Inertia in U.S Neonatal Units (vis-a-vis Probiotics)

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“More than 90% of very low birth weight (VLBW) infants receive substandard care” could be the headline of a recent article/editorial (J Pediatr 2014; 164: 980-5 & 959-60).  Instead they are titled: “Cohort Study of Probiotics in a North American Neonatal Intensive Care Unit” and “Probiotic Supplementation in Preterm Infants: It is Time to Change Practice.”

In the article introduction, the authors state: “In 2011, faced with overwhelming evidence that probiotics could decrease NEC in preterm infants, and because there were no significant risks described in the extensive literature, we decided to introduce probiotics as routine care for the prevention of NEC.”

Methods: Prospective cohort study of infants at a single center NICU.  Examined rates of necrotizing enterocolitis (NEC) and death for 17 months before and after introduction of a probiotic (FloraBABY).  This probiotic (0.5 g) was mixed with water and administered just before milk once a day.  It was started at the first feeding and continued until the infant reached 34 weeks postmenstrual age.

Key findings:

  • Probiotics reduced NEC from 9.8% to 5.4% (OR for NEC 0.51)
  • Probiotics reduced combined outcome for NEC or death from 17% to 10.5% (OR 0.56).  Reduction in death by itself did not meet statistical significance.

Why, in 2012, were probiotics only used in 8-9% of VLBW?

Potential profits for probiotics are small which has limited studies of specific strains.  The probiotic, FloraBABY, in this study cost 11 cents per day in amount used; however, since the probiotic came in a tub, the actual cost was $12.79 for a 60-g tub for each patient.  Thus, manufacturers are unlikely to support studies to garner FDA approval.

Yet, there have been 22 randomized controlled trials published which “showed substantial benefits of probiotics and no adverse events.” A recently completed ProPrems trial (Jacob S et al, presented at 2013 PAS Annual Meeting) used a probiotic called ABC Dophilus Probiotic Powder for Infants.  This trial showed “a significant, >50%, reduction in NEC despite an incidence in their control patients of only 4.4%” and despite the fact that >95% of infants received breast milk.

“Good quality control and confirmation of the contents of the preparation are essential…There seems to be no further reason to delay the introduction of this evidence-based therapy in the NICU.”  The adoption of probiotics could avoid 2500 cases of NEC every year in North America.

The editorial notes that the evidence for probiotics is much better than many other therapies used in NICUs.  They note that some have argued that “the evidence that probiotics reduce mortality rates is as conclusive as that for surfactant for respiratory distress syndrome.”  A recent Cochrane review of 17 trials and >4900 VLBW infants showed that the RR of severe NEC for probiotics versus control was 0.41.

If people really understood this issue, there would be outrage over this issue.  In the U.S., there was recently extensive coverage over inaction about a faulty ignition switch which has been linked to at least 13 deaths.  The potential reduction in NEC and deaths with probiotics is likely much greater.

While the editorial recommends involving parent representative groups, I recommend discussing this issue with your neonatology colleagues along with your “quality care” team to find out what they are going to do about it.  Given the enormous costs in most NICUs, it is likely that each unit could self-fund a quality project (with consented patients) to provide probiotics to this vulnerable population.

Bottomline: Probiotics have excellent evidence as prophylaxis for NEC in VLBW infants.  Physicians need to advocate for their usage to “avoid years of therapeutic inertia.”

Related blog post: One More Day Syndrome & Necrotizing Enterocolitis …

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.

After I Passed The Test

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After I passed my maintenance exam (American Board of Pediatrics -Pediatric Gastroenterology Subspecialty), I thought I would publish a few criticisms.

1. The test has not kept up with the digital age. In daily practice, it is a good idea to look up information and research difficult cases.  Knowing how to use these resources is more important than memorizing a lot of rare facts for an exam.

2. Why should any of the questions ask me to interpret radiographs or histology slides?  In daily practice, I would rely on my colleagues in radiology and pathology.  One of my surgical colleagues years ago used to say, “when I order a CT it should be like ordering a pizza.  Don’t ask me why I want it.  Ask me what I want on it.”  In the case of the maintenance exam, ask which test I want.  There are excellent radiologists and pathologists who are the experts at interpreting the results.

3. How is the MOC evidence-based? The popular buzz word of quality care is “evidence-based.”  Where is the data that taking the test & keeping up with the MOC (maintenance of certification) process improves physician performance?   From my discussions, it is apparent that physicians do not believe that the test “weeds” out underperforming physicians.

4. If the MOC process is so important, how come there are so many physicians who were “grandfathered” out of the requirements?  While the official line to this question is that the “diplomates” at that time who were board-certified were not time-limited, an honest answer is that it was the only politically feasible way to get enough physician support.

As a whole, these criticisms indicate the difficulty in designing a test to assess whether a physician has the necessary competencies.  As alluded to in a previous post (Training Not Meeting Procedure Thresholds for Fellows …), it is crucial that physicians gain the necessary experience/knnowledge in their training.

The MOC has lofty goals of assuring that physicians acquire and maintain their skills.  Yet, the current approach does not meet these goals.  Ultimately, the burden on a physician, like in other career pathways, on keeping up his knowledge and clinical skills relies mainly on the conscientious individual.  Those interested in taking shortcuts will do this and the current system is merely a nuisance.

“Low quality of evidence; strong recommendation” for Probiotics in Gastroenteritis

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Recently a position paper on “Use of probiotics for management of acute gastroenteritis: a position paper by the ESPGHAN working group for probiotics and prebiotics” was published (JPGN 2014; 58: 531-39).

Two specific probiotics were recommended “strongly” but the working group describes the evidence for both as “low quality.”  This strikes me as odd.  The authors extensively reviewed previous studies and used the “GRADE” system to classify the quality of evidence and the category of recommendation.  There were 4 categories of quality of evidence: high, moderate, low and very low.  There were 2 possible recommendation categories: strong or weak.

The summary recommendations included the following:

  • Rehydration is the key treatment for AGE
  • Probiotics, overall, reduce diarrhea by approximately 1 day
  • However, probiotic effects are strain specific; findings from one probiotic cannot be extrapolated to another
  • The group recommends choosing probiotics with efficacy confirmed in well-conducted RCTs from a reputable manufacturer
  • Two specific recommended probiotics: Lactobacillus GG and Saccromyces boulardii

Take-home message: This article summarizes the available evidence for the use of probiotics in acute gastroenteritis.  Despite their classification as  “low quality of evidence,” the authors provide a strong recommendation for two probiotics (Lactobacillus GG and Saccromyces boulardii) as adjunctive therapy.

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Why Rich Kids Get Measles More Often in the U.S.

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Most of the time, having more wealth and education translates into better health care outcomes.  One exception has been with some vaccine-preventable illnesses like the measles, according to a recent article in USA Today which reported on the CDC’s efforts to counter anti-vaccination misinformation.

Here’s an excerpt:

Vaccines given to infants and young children over the past two decades will prevent 322 million illnesses, 21 million hospitalizations and 732,000 deaths over the course of their lifetimes, according to a new report from the Centers for Disease Control and Prevention.

Vaccines also will have saved $295 billion in direct costs, such as medical expenses, and a total of more than $1.3 trillion in societal costs over that time, because children who were spared from sometimes-devastating illnesses will be able to contribute to society, the report shows. These calculations may underestimate the full impact of vaccines, the study notes, because authors considered only the early 14 routine childhood immunizations typically required for school entry. Authors didn’t include flu shots or adolescent vaccines given at ages 11 or 12…

Before the measles vaccine became available in 1963, the virus infected about 500,000 Americans a year, causing 500 deaths and 48,000 hospitalizations. In recent years, the number of diagnoses fell to around 60 to 65, mostly in isolated travelers arriving in the USA.

Doubts about vaccines safety – and fading memories of vaccine-preventable diseases — have contributed to a resurgence of nearly forgotten diseases such as measles, which was officially declared eradicated in the USA in 2000. Numerous studies have debunked the notion that vaccines cause autism or other chronic diseases, says William Schaffner , an infectious disease specialist and professor at the Vanderbilt University School of Medicine in Nashville….

Congress created the entitlement program in 1994, responding to a measles outbreak in 1989 to 1991 that sickened 55,000 people and killed more than 100. At the time, measles outbreaks were fueled by viruses circulating among low-income, inner-city residents.

The picture has completely changed today, Schaffner says. The federal program has eliminated racial and ethnic disparities among vaccines. Today, the bulk of the unvaccinated children come from wealthy, educated families where parents intentionally choose not to immunize them, due to concerns about vaccine safety. These relatively wealthy children can then spread measles after returning from vacations in Europe, which has had large outbreaks for several years, Schaffner says.

“Borders can’t stop measles, but vaccination can,” says CDC Director Tom Frieden.

Life and Limb: The Price of Not Vaccinating Children

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A recent article in USA Today focused some light on the issue of vaccine avoidance and its consequences. Two specific examples in the article included the death of an infant to pertusis and healthy boy who lost his arms and legs as a consequence of the measles. In my opinion, the authors and editors of this publication make a mistake by offering up too much credence to the vaccine naysayers presumably to provide a “balanced report.”  Their arguments should have been subjected to further scrutiny.  Here’s the link, decide for yourself:

http://usat.ly/1lEVlOe

Excerpt:

Recent measles outbreaks in New York, California and Texas are examples of what could happen on a larger scale if vaccination rates dropped, says Anne Schuchat, the CDC’s director of immunizations and respiratory diseases. Officials declared measles, which causes itchy rashes and fevers, eradicated in the United States in 2000. Yet this year, the disease is on track to infect three times as many people as in 2009. That’s because in most cases people who have not been vaccinated are getting infected by others traveling into the United States. Then, Schuchat says, the infected spread it in their communities.

The 189 cases of measles in the U.S. last year is small compared with the 530,000 cases the country used to see on average each year in the 20th century. But, the disease — which started to wane when a vaccine was introduced in 1967 — is one of the most contagious in the world and could quickly go from sporadic nuisance to widespread killer.

Measles kills about once in every 1,000 cases. As cases mount, so does the risk. “We really don’t want a child to die from measles, but it’s almost inevitable,” says Schuchat. “Major resurgences of diseases can sneak up on us.”…

Even so, in some states the anti-vaccine movement, aided by religious and philosophical state exemptions, is growing, says Paul Offit, chief of infectious diseases at Children’s Hospital of Philadelphia. He points to states like Idaho, Illinois, Michigan, Oregon and Vermont — where more than 4.5% of kindergartners last year were unvaccinated for non-medical reasons — as examples of potential hot spots. Such states’ rates are four times the national average and illustrate a trend among select groups.

“People assume this will never happen to them until it happens to them,” Offit says. “It’s a shame that’s the way we have to learn the lesson. There’s a human price for that lesson.”

The most vulnerable are infants who may be too young to be vaccinated, children with compromised immune systems and others who may be unable to be vaccinated for medical reasons, scientists say.

Related blog posts:

‘Little’ Knowledge Exists Regarding Medicines for Neonates

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Despite federal legislation encouraging the study of products used in the pediatric population, very little of these studies has translated into meaningful information regarding neonates (JAMA Pediatr 2014; 168: 130-36, thanks to Ben Gold for this reference).

This publication reviewed studies submitted to the FDA between 1997-2010.  The authors identified all drugs with pediatric studies that included neonates.  Subsequently, the use of these drugs was examined in a oohort of neonates admitted to 290 neonatal intensive care units (NICU) (Pediatrix Data Warehouse) in the U.S. form 2005-2010.

Key findings:

  • 28 drugs (in 41 studies) were examined in neonates. This led to 24 labeling changes.
  • 11 of 24 neonatal labeling changes included an approval for use in neonates, including 4 for HIV and 3 for anesthesia.
  • 13 of 24 labeling changes were the following: “safety and effectiveness have not been established.”  These drugs included several reflux medications: esomeprazole, lansoprazole, pantoprazole, and ranitidine.
  • In the Pediatrix database involving 446,335 hospitalized neonates, there were 399 different drugs identified that had been administered.  Of the 28 studied drugs, the gastroesophageal reflux medicines were used most frequently.  13 of the 28 studied drugs were not used at all in the NICUs.
  • Of the 11 drugs with a neonatal indication, 7 were never used in the Pediatrix neonatal population and the other 4 drugs were used infrequently.

Conclusions:

  • Neonates are a vulnerable and an understudied population
  • Most of the exposure to drugs was off-label for neonates.
  • Most often, off-label drugs were prescribed “despite studies indicating they were not effective…For example, ranitidine, lansoprazole, and inhaled nitric oxide (for the prevention of bronchpulmonary dysplasia) were the top 3 drugs used in neonates…none have FDA labelling for the indication studied because of lack of efficacy.”
  • Furthermore, drugs like ranitidine and lansoprazole” are associated with serious adverse effects in neonates.” (Clin Perinatol 2012; 39: 99-109)

Related blog entries:

Male Vulnerability Factor?

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A recent study examined mortality data from 1999-2008, comparing male deaths to female deaths (Pediatrics 2013; 132: 631-38) –thanks to Ben Gold for this reference.

Here’s a link to the abstract:  Pediatric Mortality in Males Versus Females in the … – Pediatrics

This study reviewed mortality data, including data from the CDC’s WONDER (wide-ranging online data for epidemiologic research) system .

Key Findings:

  • Males had higher relative risk of dying in all age groups with a relative risk of 1.44.
  • Males had higher mortality rates in 17 of 19 major ICD-10 categories (including cancer), thus this does not appear to be simply a matter of more accidents.
  • Even between 15-19 years when accidental and nonaccidental trauma were excluded males continue to demonstrate an increased relative risk of death.

While this study is limited by relying on the accuracy of coding for underlying cause of death, it supports the idea that males have a higher mortality throughout their lifespan.