The Best Way to Handle Vaccine Skeptics

According to a recent NY Times editorial, the best way to improve vaccination rates is not to mandate universal vaccination or to label ‘anti-vaxxer’ parents as ignorant.  The best way is to make it more difficult to receive personal exemptions –this is something the government can be quite good at.

Here’s the link: How to Handle Vaccine Skeptics -NY Times

Here’s an excerpt:

They [States} can require parents to write a letter elaborating on the reason their child should be exempt. They can require that the letter be notarized. They can insist that parents read and sign a form that discusses the risks of nonvaccination. Better yet, they should mandate in-person counseling so that the decision not to vaccinate is truly informed.

States can also require that parents obtain an exemption form by specifically requesting one from the state or local health department, rather than downloading it online. They can insist that these parents acknowledge that they will be responsible for keeping the children away from school during outbreaks. Moreover, they should have procedures to review each request for exemption rather than automatically approving them, as many states do now. And they should require parents with exemptions to apply annually for renewal…

 In a 2012 study, which my colleagues and I [Saad Omer] published in The New England Journal of Medicine, nonmedical exemption rates were 2.3 times higher in states with easy administrative policies for granting exemptions (like Connecticut, Missouri and Wisconsin) than in states with difficult policies (like Florida, Minnesota and Texas). Moreover, the annual rate of increase in nonmedical exemptions was about 60 percent higher in states with easy exemption policies compared with states with difficult policies.

Progress in Cystic Fibrosis over 18 Years

A recent study (J Pediatr 2014; 165: 1091-7) showed significant improvement in lung function among 6-year-olds with Cystic Fibrosis (CF) between 1994-2012.

Using the Cystic Fibrosis Foundation Patient Registry with a total of 11,670 children, the authors found that the mean FEV1 and FVC z-scores increased significantly over the period in the entire cohort.  In addition, the height-for-age (HFA) also improved.  These results are easy to see graphically in Figures 1 & Figure 2.  The authors note that in 2012, children who were identified by screening had improved HFA, FEV1, and FVC compared to children who were not identified by screening.

Take-home points:

  • These data show impressive improvement in lung function and growth over the past two decades
  • These values are going to improve further now that all 50 states mandate newborn screening for CF
  • While there is improvement, 6-year-olds with CF still have measurable pulmonary dysfunction; thus, more work is needed, perhaps with novel therapies.

Related blog posts:

Leptin Deficiency and Early-Onset Extreme Obesity

A brief report (NEJM 2015; 372: 48-54) details a case of 2.5 year old who weighed 33.7 kg (>99.9% and z score of 7.2) and had BMI of 38.6 (>99.9% and z score of 5.8).

Link to article (and picture/growth curve)

The authors determined that he had a mutation which caused biologically inactive leptin.  Subsequently, treatment with metreleptin injections, improved eating behavior and resulted in substantial weight loss.

Key points:

  • “Current clinical recommendations advise that leptin serum concentrations be measured in children who have rapid weight gain in the first months of life.” (“The severely obese patient –a genetic work-up.” Nat Clin Pract Endocrinol Metab 2006; 2: 172-7)
  • This case report demonstrates that normal circulating levels of the hormone “do not rule out disease-causing mutations in the gene encoding leptin.”

Related blog posts:

Screen Shot 2015-01-01 at 5.12.58 PM

1400 Different Immunization Schedules -What Could Go Wrong?

A recent study (J Pediatr 2015; 166: 151-6) has examined the frequency of “alternative” (non-standard) vaccination schedules among 222,628 children in New York (2009-2011), using a statewide mandatory immunization information system.

Key findings:

  • 25% of children followed an non-standard immunization schedule.
  • At 9 months of age, children on an non-standard schedule were less likely to be up-to-date (15% compared with 90%, P<0.05).

The authors note that in a separate study that there were “1400 individualized vaccination patterns.”  These patterns break down into three: delays of vaccine, selective refusal of specific vaccines, and reduction in the number of vaccines.

In a brief summary, Sarah Long notes that for parents/doctors –“Although their intent is heightened protection of their children/patients from harm, the result is the opposite.  Alternative “schedules” are completely untested for immunogenicity or safety.”

One limitation of this study is that it was conducted in New York.  There is wide variability in the resistance to vaccination among states.

Bottomline: Their has been an increase in the use of non-standard vaccine schedules.  This is contributing to community vulnerability to vaccine preventable diseases.

A related story: “Disneyland” Measles Outbreak (from USA Today) and from NY Times (1/21/15): Measle cases linked to Disneyland (& unvaccinated students).  1/28/15 Measles in Arizona reaches ‘critical point’

Related blog posts:

AAP -Behind the Scenes (Part 2)

Besides the focus on legislation and access to care, the AAP meeting provided an infectious disease update from Dr. Harry Keyserling, membership update by Dr. Roma Klicius, the Pediatric Foundation Report by Dr. Bob Wiskind, an update on oral health care by Dr. Chevron Brooks, a brief update on AAP Friends of Children by Dr. Jay Berkelhammer, and discussion about transitional care.

With regard to the infectious diseases update, Dr. Keyserling noted that despite the flu vaccine’s lower “match” this year and its reduced effectiveness, it is still quite important to receive the flu vaccine.

  • Each year, about 1/3rd ot the population gets the flu.
  • About 1 in 10,000 people die due to the flu.
  • In 2012-13, there were 171 pediatric deaths across the country due to influenza.  90% of these deaths occurred in children who were not immunized; in other words, for a child with the flu, the risk of death is more than 10 times higher in those who do not receive the immunization.

Here are a couple of slides (used with permission) regarding the flu:

Risk of Death from the Flu

Risk of Death from the Flu

Flu Data thru Jan 2015

Flu Data thru Jan 2015

Flu Vaccine Coverage

Flu Vaccine Coverage

Bottomline: The AAP is working on preventing deaths from all vaccine-preventable deaths, including the flu.

Related blog posts:

Since my job at the AAP is to work on nutrition-related issues, I would welcome suggestions for areas of concern.  As there are separate areas devoted to obesity and breastfeeding, my goal is to work on other aspects of nutrition in children.  Some ideas that have come up already include an update on gluten-related disorders and nutritional supplements.  Any other advice?

Upcoming AAP Schedule

Upcoming AAP Schedule

AAP -Behind the Scenes (Part 1)

Recently I was asked to become a board member for the Georgia Chapter of the American Academy of Pediatrics (AAP) in the role of chair of the section of nutrition.  My role at this meeting was limited.  I was impressed by the commitment of the participants and by the range of activities that the AAP chapter was working on –all in the efforts of improving the health of children in Georgia.

I only took a few notes but here are some of the details.  Dr. Evelyn Johnson (President) provided the president’s report and an overview of the chapter activities.

Dr. Anu Sheth provided an update on the Medicaid Task Force.  This issue was discussed in some detail.  The issue at stake is the low reimbursement for office visits for children with Medicaid coverage; the rate has not changed in 13 years with one notable exception.  In 2013-2014, the federal government provided a one-time boost in the rates of Medicaid reimbursement with the role out of the ACA (Obamacare) to encourage availability of primary care physicians to see the new enrollees.  There is preliminary evidence that this boost did improve access to care.

According to a recent study (NEJM 2015; January 21, 2015DOI: 10.1056/NEJMsa1413299), “Our study provides early evidence that increased Medicaid reimbursement to primary care providers, as mandated in the ACA, was associated with improved appointment availability for Medicaid enrollees among participating providers without generating longer waiting times.”

Since 43.2% of all children in Georgia receive their health insurance through Medicaid this is a big issue.  It is also directly related to another topic of provider access.  61 counties in Georgia have a deficit of needed pediatricians and 23 counties have no pediatrician at all.  Currently, Medicaid rates to physician practices are only about 75% of Medicare rates and compared to commercial insurance plans, they pay only half.

Based on these considerations, the AAP is urging its members to contact their state legislators, particularly those more involved in the budget decision-making process.  While bumping Medicaid rates in the face of other budget constraints may be difficult, default limiting of access results in higher costs through emergency room visits and complications.

Georgia Politicians with Greatest Impact on Healthcare Decisions

Georgia Politicians with Greatest Impact on Healthcare Decisions

Rural communities are more affected by access issues than urban counties.  Dr. Angela Highbaugh-Battle provided an update on the Governor’s Rural Hospital Task Force.  There have been a number of hospital closures and more appear to be imminent.  Communities that are losing hospitals are losing important jobs, access to timely care, and will have difficulty attracting new businesses.

Another related topic was the issue of ‘retail-clinic’ healthcare.  While the ease of access is quite helpful for families, there are numerous concerns about the quality of care.  Several clinicians described their efforts to provide alternatives including extended hours in their practices and weekend hours as well.

Here’s a related article: “Retail clinics are in, traditional primary care practices are out”

One fascinating aspect about the discussion of retail clinics was its juxtaposition with efforts to improve the process of remaining board-certified (See related blog: Resistance to Maintenance of Certification | gutsandgrowth).  Given the increasing use of retail-clinics and midlevel providers, several clinicians emphasized that board-approval is not a strong consideration for families seeking healthcare.  The fact that the board approval process is not tied to a broad effort to show its impact on patient care and/or to market the efforts of pediatricians has led to widespread dissatisfaction.

Take-home message: The issue of adequate access to primary care physicians along with high quality care is important for everyone.  Make your voice heard!

Related blog posts:

 

What’s Wrong with “I Want My Kid Tested For Food Allergies”

Most parents, and many physicians, do not understand the limitations of food allergy testing.  As I am sure is common among physicians, I frequently receive requests for food allergy testing; parents do not realize that the strategy for food allergy testing is not straight-forward and has not advanced significantly for decades.  This information is detailed in a recent study and associated editorial (J Pediatr 2015; 166: 97-100, editorial 8-10: “Pitfalls in Food Allergy”).

The study was a retrospective review of all new patients seen at a pediatric food allergy center (2011-2012).  This involved a review of 797 new patients.

Key findings:

  • Of 284 patients who had received a food allergy panel, only 90 (32.8%) had a history warranting evaluation for food allergy.
  • Among 126 individuals who had food restrictions imposed based on food allergy panel testing, 112 (88.9%) were able to re-introduce at least 1 food into their diet.
  • The positive predictive value of food allergy testing was 2.2%.

So what can we learn from this study and editorial?

Misdiagnosis often relates to a lack of understanding regarding serum IgE-based testing.  First of all, many children with atopic dermatitis (and other atopic conditions) have elevated total IgE which results in more false positives.  In addition, a positive IgE test for a specific food indicates sensitization but not necessarily an allergy.

Strategy for testing (recommended by editorial):

  • “The key to the diagnosis of food allergy cannot be overstated; it begins with a detailed clinical history”
  • Testing should be “limited in general to the food(s) in question.”
  • When there is uncertainty, oral food challenges can be performed by specialists.
  • “If a patient is consuming a food without clinical symptoms of allergy, allergy testing should not be done to that food.”

Bottomline (from authors’ conclusion): “Food allergy panel testing often results in misdiagnosis of food allergy, overly restrictive dietary avoidance, and an unnecessary economic burden on the health system.”

Related blog posts:

 

Positive Results for Probiotics in Latest Study of Colicy Infants

While not all studies have demonstrated benefit of probiotics for infant colic, many have, particularly in breastfed infants.  The latest study (J Pediatr 2015; 166: 74-78) shows that “administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants.”

This study was conducted between 2012-2014 and enrolled 52 infants.  These infants were randomized to either probiotics or placebo; the study was double-blind as well.

Key results:

  • For the 21 day study:  Total average crying and fussing times for probiotic group was 1719 ± 750 minutes compared with 2195 ± 764 minutes in the placebo group. (P=0.028)
  • At the end of the study, the probiotic group crying/fussing for 60 minutes per day compared with 102 minutes/day in the placebo group.  (P=0.045)

Take-home message: In breastfed infants, the probiotic L reuteri DSM 17938 reduced crying.

Related blog posts:

Miralax -More Scrutiny, Research Study

A recent NY Times article is probably ‘required reading’ for all pediatric gastroenterologists, pediatricians, and family practitioners:

Here’s the link: Mirlax -Scrutiny for a Childhood Remedy

Here are some excerpts:

The [FDA] agency has asked a team of scientists in Philadelphia to look more closely at the active ingredient in Miralax and similar generic products, called polyethylene glycol 3350, or PEG 3350. While outlining the scope of the research, the agency also disclosed that its scientists had discovered trace amounts of two potential toxins in batches of Miralax tested six years ago.

The news is likely to surprise parents and some doctors.

“Every pediatric GI physician, I would guarantee you, has told a family this is a safe product,” said Dr. Kent C. Williams, a gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio. Now, he worries, “it may not be true.”

Doctors have long recommended these laxatives for their convenience and on the grounds that very little PEG 3350 is absorbed in the intestines. But the F.D.A. says there is little data on its absorption in children, especially the very young and chronically constipated. The agency never approved long-term daily use of the laxatives, even in adults….

Moreover, for years the F.D.A. has received occasional reports of tremors, tics and obsessive-compulsive behavior in children given laxatives containing PEG 3350. It is not known whether the laxatives are the cause….

The F.D.A. said that it had tested eight batches of Miralax and found tiny amounts of ethylene glycol (EG) and diethylene glycol (DEG), ingredients in antifreeze, in all of them. The agency said the toxins were impurities resulting from the manufacturing process.

Those tests were conducted in 2008..The agency again tested PEG 3350 laxatives from five makers in 2013, Mr. Ventura said. None had detectable amounts of EG or DEG. “The amounts were so low,” he added, and “complied with internationally recognized safety standards.”

Bottomline: The previous pediatric studies of Miralax that have been published have shown favorable benefits and not disclosed adverse effects.  It is difficult to exclude the possibility that there is a small subset of children in which Miralax results in adverse effects.  As with many medications, more pediatric data is needed.

Question: Will this or should this change how Miralax is discussed with families?

Related blog posts:

Prenatal Testing, Statistics, and Life-Altering Decisions

Much of my day is spent interpreting lab work.  Sometimes it is very easy but not always. Many families and health care professionals do not understand the concepts of sensitivity, specificity, positive predictive value and negative predictive value.  These values are affected greatly by the prevalence of the condition (or disease) that is being tested for in a specific population.

For many conditions, doctors prefer a highly sensitive test.  Tests that are highly sensitive will detect almost all of the individuals with the condition (or disease) being tested for and miss very few people (false-negative) with the condition. However, tests that are very sensitive often detect individuals who do not have the condition (false-positives). Therefore, when using tests with high sensitivity, more precise followup tests can determine conclusively if the condition (or disease) is present with much greater specificity.

A report from NBC news highlights how tests that are billed as “99 percent” accurate can be quite difficult to interpret and could lead to abortions of healthy fetuses.  Here’s the link: Sensitivity, Positive Predictive Value, and Prenatal Testing

Here’s an excerpt:

Positive results can be wrong 50 percent or more of the time…Noninvasive prenatal tests, or the “cell free DNA test,” are merely screening tests of placental DNA found in the mother’s blood…

The true likelihood that a positive test is positive depends on another calculation — the positive predictive value or PPV, which factors in other variables, such as a woman’s age and the prevalence of the disease in that population…

A woman over 35 where genetic disorders are more common — the likelihood of Trisomy 18 given a positive screening result is about 64 percent. For a younger woman, the PPV would be under 50 percent, according to the investigation.

Another example of understanding tests and statistics involves mammograms.  The relatively low reduction in averted cancer deaths related to mammograms has been discussed previously on this blog (see links below).  A good infographic and description is also available at NPR.  Here’s the link: What happens after your mammogram

 

Related blog posts:

Blue-footed Booby

Blue-footed Booby