Author Archives: gutsandgrowth

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About gutsandgrowth

I am a pediatric gastroenterologist at GI Care for Kids (previously called CCDHC) in Atlanta, Georgia. The goal of my blog is to share some of my reading in my field more broadly. In addition, I wanted to provide my voice to a wide range of topics that often have inaccurate or incomplete information. Before starting this blog in 2011, I would tear out articles from journals and/or keep notes in a palm pilot. This blog helps provide an updated source of information that is easy to access and search, along with links to useful multimedia sources. I was born and raised in Chattanooga. After graduating from the University of Virginia, I attended Baylor College of Medicine. I completed residency and fellowship training at the University of Cincinnati at the Children’s Hospital Medical Center. I received funding from the National Institutes of Health for molecular biology research of the gastrointestinal tract. During my fellowship, I had the opportunity to work with some of the most amazing pediatric gastroenterologists and mentors. Some of these individuals included Mitchell Cohen, William Balistreri, James Heubi, Jorge Bezerra, Colin Rudolph, John Bucuvalas, and Michael Farrell. I am grateful for their teaching and their friendship. During my training with their help, I received a nationwide award for the best research by a GI fellow. I have authored numerous publications/presentations including original research, case reports, review articles, and textbook chapters on various pediatric gastrointestinal problems. In addition, I have been recognized by Atlanta Magazine as a "Top Doctor" in my field multiple times. Currently, I am the vice chair of the section of nutrition for the Georgia Chapter of the American Academy of Pediatrics. In addition, I am an adjunct Associate Clinical Professor of Pediatrics at Emory University School of Medicine. Other society memberships have included the North American Society for Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN), American Academy of Pediatrics, the Food Allergy Network, the American Gastroenterology Association, the American Association for the Study of Liver Diseases, and the Crohn’s and Colitis Foundation. As part of a national pediatric GI organization called NASPGHAN (and its affiliated website GIKids), I have helped develop educational materials on a wide-range of gastrointestinal and liver diseases which are used across the country. Also, I have been an invited speaker for national campaigns to improve the evaluation and treatment of gastroesophageal reflux disease, celiac disease, eosinophilic esophagitis, hepatitis C, and inflammatory bowel disease (IBD). Some information on these topics has been posted at my work website, www.gicareforkids.com, which has links to multiple other useful resources. I am fortunate to work at GI Care For Kids. Our group has 17 terrific physicians with a wide range of subspecialization, including liver diseases, feeding disorders, eosinophilic diseases, inflammatory bowel disease, cystic fibrosis, DiGeorge/22q, celiac disease, and motility disorders. Many of our physicians are recognized nationally for their achievements. Our group of physicians have worked closely together for many years. None of the physicians in our group have ever left to join other groups. I have also worked with the same nurse (Bernadette) since I moved to Atlanta in 1997. For many families, more practical matters about our office include the following: – 14 office/satellite locations – physicians who speak Spanish – cutting edge research – on-site nutritionists – on-site psychology support for abdominal pain and feeding disorders – participation in ImproveCareNow to better the outcomes for children with inflammatory bowel disease – office endoscopy suite (lower costs and easier scheduling) – office infusion center (lower costs and easier for families) – easy access to nursing advice (each physician has at least one nurse) I am married and have two sons (both adults). I like to read, walk/hike, bike, swim, and play tennis with my free time. I do not have any financial relationships with pharmaceutical companies or other financial relationships to disclose. I have helped enroll patients in industry-sponsored research studies.

WSJ: How Pfizer Settled on $9,850 per Month for New Drug

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WSJ:  How Pfizer Set the Cost of Its New Drug at $9,850 a Month

An excerpt:

The average cost of a branded cancer drug in the U.S. is around $10,000 a month, double the level a decade ago

Pfizer’s multistep pricing process shows drugmakers don’t just pick a lofty figure out of the air. At the same time, its process yielded a price that bore little relation to the drug industry’s oft-cited justification for its prices, the cost of research and development.

Instead, the price that emerged was largely based on a complex analysis of the need for a new drug with this one’s particular set of benefits and risks, potential competing drugs, the sentiments of cancer doctors and a shrewd assessment of how health plans were likely to treat the product…

In 2013, Pfizer hired outside firms to conduct hourlong interviews with more than 125 cancer doctors in six cities…

Pfizer hired firms that surveyed more than 80 health-plan officials such as medical directors and pharmacists…

Pfizer employees say the mock reviews supported a monthly price below $10,000. If it was higher, insurers could start requiring doctors to fill out paperwork justifying its use.

My take: This article makes clear that the driver of higher pharmaceutical prices is based on a shrewd assessment of what the market will bear.

Related blog posts:

My Favorite Posts from the Past Year

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Recently, I listed the posts that had the most views in the past year –some dating back to 2012.  The following list includes less viewed but some of my favorite posts from 2018:

GI:

Nutrition:

LIVER:

Miscellaneous:

Flowers in Calgary

Most Popular Posts 2011-2018

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Since this blog’s inception, there are now more than 2500 posts; these are the most popular (most views):

Most of these posts are referenced in more recent posts on the same or similar subjects.

Near Banff

 

PEG-B-ACTIVE Study: Efficacy of Peginterferon for Children with Hep B

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A recent randomized controlled, open-label study (S Wirth et al. Hepatology 2018; 68: 1681-94) examined the use of weekly peginterferon alfa-2a (PEG) in 161 children (3-18 yrs) with immune-active HBe-Ag-positive children.  The two main groups were for those without advanced fibrosis: a PEG group (n=101) and a placebo group (n=50).  A third group enrolled 10 patients with advanced fibrosis who all received PEG. The treatment period was 48 weeks with ongoing observation for an additional 24 weeks.

Key findings:

  • The PEG group had HBeAg seroconversion of  8% at 48 weeks and 26% at 72 weeks; the placebo group had HBeAg seroconversion of 6% at both timepoints. At 72 weeks, the odds ratio was 5.43 for the PEG group and P=0.0043.
  • HBsAg clearance rates were higher in the PEG group: 8.9% vs 0% in placebo group.
  • The authors showed response (loss of HBeAg) by age and those <5 years had the highest response 43% (6 of 14).  The rate of seroconversion was 30.2% in those <12 years compared with 20.8% in those ≥12 years.
  • The authors showed response (loss of HBeAg) those with ALT values between 2-<5 had the highest response of 35% (15 of 43).
  • Adverse events were frequent –among the 101 treated patients: 49 with pyrexia, 30 with headache, 19 with abdominal pain, 15 with influenza-like illness, 14 with vomiting, 61 with ALT >5 x ULN, 25 with ALT >10 x ULN, 19 with neutropenia (ANC <750), and two with self-limited increased thyroid-stimulating hormone. These were all much higher than in the placebo group

My take: This study does not answer the question about which treatment is optimal for hepatitis B in children–direct-acting antivirals (eg. entecavir, and tenofovir) or peginterferon.  It does shows that weekly peginterferon alfa-2a was associated with HBeAg seroconversion in 26% of recipients at week 72.  Although a high number of patients experienced adverse effects, there were no new safety signals identified.

Related blog posts:

View from Parker Ridge, near Banff

Most Popular GutsandGrowth Posts from Past Year

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These five posts were the most popular (most views) in the past year:

This is a bike path from Canmore to Banff. I had a chance to ride an electric bike which was a lot of fun.

Cirrhosis and Cardiac Function

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Briefly noted: M Izzy, J Oh, KD Watt. Hepatology 2018; 68: 2008-2015.  This concise review discusses the outcome of cirrhotic cardiomyopathy after liver transplantation.

Key point: “Although it is often believed that cirrhotic cardiomyopathy resolves post-LT, the data, albeit limited, do not support this postulation…diastolic function may not improve post-transplant and may actually worsen. Improvement in systolic function was suggested by only two of six studies.”

Related blog post: Cholecardia

This figure from Hepatology November cover depicts a cirrhotic liver restricting the heart filling during diastole. (From Wiley Online Library -free access)

Which Diet is Best For a Fatty Liver?

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A recent randomized controlled trial (C Properzi et al. Hepatology 2018; 68: 1741-54) compare the Mediterranean diet (MD) and a low-fat (LF) diet for non-alcoholic fatty liver disease.

A total of 48 patients completed the 12-week study and were analyzed; subjects had a mean BMI of 31.  Both groups consumed a 2400-2600 kcal diet.

Key findings:

  • Despite minimal weight loss, both groups had significant reduction in hepatic steatosis as determined by magnetic resonance spectroscopy (MRS): 25.0% in LF and 32.4% in MD.  Both had wide confidence intervals due to the small number of subjects.
  • Liver enzyme improved in both groups.
  • Weight loss was minimal, 1.6 kg and 2.1 kg in LF and MD respectively
  • Framingham Risk Score (FRS), cholesterol, triglycerides, and hemoglobin A1c were improved with MD but not with LF (all P<0.05)

The associated editorial (pg 1668-71) notes the following:

  • “Considering the current evidence, recommending the MD for patients with NAFLD might be an appropriate therapeutic option, not least because …[of the} increased risk of CVD.”
  • Longer-term RCTs are needed
  • “It has to be stressed that, in most cases, any form of healthy diet (eg. LF or MD), which leads to caloric reduction…should be encourage for patients with NAFLD…The importance of weight loss has been highlighted in patients with biopsy-proven NASH.”

My take: If you have to make a dietary recommendation, this study indicates that MD is probably a better diet than LF in patients with NAFLD.

Related blog posts:

Town of Banff

 

 

How Important Are Proton Pump Inhibitors for Intensive Care Patients?

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A recent randomized, blinded study (M Krag et al. NEJM 2018; 379: 2199-2208, editorial 2263-4) describes the use of proton pump inhibitor (PPI) therapy in adults (n=3298) in the ICU at high risk for gastrointestinal bleeding. High risk features included liver disease, coagulopathy, shock, anticoagulant therapy, renal replacement treatment, and mechanical ventilation.

Key findings:

  • Stress-ulcer bleeding may be less prevalent than in the past, perhaps due to improved ICU care. GI bleeding occurred in 4.2% of placebo-treated patients compared to 2.5% of pantoprazole-treated patients
  • Overall outcomes were essentially identical. At 90 days, 510 patients (31.1%) in the pantoprazole group and 49 (30.4%) in the placebo group had died (RR 1.02).
  • Using a composite event score to weight potential good and adverse effects (eg C diff infection, myocardial infarction, bleeding, pneumonia) of PPI therapy, the authors found that this occurred in 21.9% of pantoprazole group compared with 22.6% of placebo group (22.6%).

Reduction in GI bleeding could be related in part to the more frequent use of enteral feedings.  And, the combination of enteral feeding with the use of PPI treatment may increase the risk of pneumonia.

In the associated commentary, the authors note that “prophylaxis with a PPI, if initiated, should be reserved for seriously ill patients who are at high risk for this complication.” They acknowledge a lack of a uniform definition of high risk and the “admittedly small (1.7%) difference in bleeding rates.”

 

Rolling Back School Lunch Standards

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NY Times: Trump Administration Rolls Back Obama-Era Rules for School Lunches

An excerpt for 12/8/18:

This week, the United States Department of Agriculture announced its final plans to lower nutrition standards for grains, flavored milks and sodium in school cafeterias that were part of the Healthy, Hunger-Free Kids Act of 2010 …

The Obama-era rules required that schools must serve entirely “whole grain-rich” foods, meaning that the product — whether it is pizza, pasta or hamburger buns — must contain at least 50 percent whole grains…Under the new rules, only half of the grain products on the cafeteria’s weekly menu must be whole grain-rich….

It was unclear why the Trump administration would backtrack when schools were in good standing with the nutritional goals… more than 99 percent of schools in the country reported that they were meeting the Obama-era standards…

“It seems like a small thing,” she said. “But the behavioral research shows you have to offer nutritious food to kids over and over and be consistent.”

Related blog posts:

Overdiagnosis of Cow’s Milk Protein Allergy in Infants and Formula Industry Influence

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From BMJ: -Link: Overdiagnosis and industry influence: how cow’s milk protein allergy is extending the reach of infant formula manufacturer

This article provides a detailed discussion of this topic. Two key points:

  • Because the diagnosis of non-IgE mediated cow’s milk protein allergy is based mainly on a formula trial/reintroduction, it is susceptible to overdiagnosis
  • Expert guidelines have been authored mainly by those with conflicts of interest

An excerpt:

Clinicians and patients who spoke to The BMJ are concerned at the wide availability of industry funded online information promoting non-specific symptoms potentially indicating cow’s milk allergy as a diagnosis in exclusively breastfed infants. Although there is evidence that cow’s milk and other food proteins can be transferred from mother to infant in breastmilk, the quantities transferred are likely to be too small to cause symptoms in most infants.