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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
July 15, 2017

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EpiPen Price and PBMs
Children Demonstrate Significant Weight Bias)
Prenatal Fevers Increase Risk for Autism
Concussion in Adolescent Girls Is Associated with Irregular Menses
North American Menopause Society Updates its Position Statement on
   Hormone Therapy: 2017
Fecal Microbiota Transplant for Recurrent Hepatic Encephalopathy

EpiPen Price and PBMs
A new class-action lawsuit challenging the price of EpiPens is targeting not the drug's manufacturer but three PBMs and the industry's rebate practices.
The lawsuit alleges that CVS Health, Express Scripts, and Prime Therapeutics practice price gouging; this includes a more than 500% increase in EpiPen's price from 2007 to 2016 by demanding increased rebates from manufacturers in exchange for favorable placement on their formularies.
Drug companies have incentives to raise prices, according to the lawsuit, in order to give larger rebates to the PBMs who then pocket significant revenues and don't pass the savings along to patients. 
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Pediatrics 2017 Jul; 140:e20163936
Children Demonstrate Significant Weight Bias
By age 9, children have implicit bias against overweight people.
Obese children and adolescents report high levels of victimization by peers, family, teachers, and healthcare providers. The stigma of being obese has been linked to depression, anxiety, poor academic performance, troubled social relationships, and suicidal ideation. Studies in adults demonstrate implicit bias against overweight people. Using a validated method (the Affect Misattribution Procedure), researchers evaluated implicit weight bias in 114 children aged 9 to 11 years. Most participants (71%) were healthy weight, 21% were overweight, and 8% were underweight.
Participants were shown 9 pairs of photographs — in each pair, a child followed by a fractal — and were asked to rate the second image as “good” or “bad.” The difference in the proportion of “good” ratings for fractal images shown after an image of a healthy-weight child versus an overweight child was used as a measure of implicit bias (bias the person is unaware he holds).
Overall, there was a significant implicit bias of 5.4% against overweight people. Healthy-weight children had greater bias (7.9%) than those who were overweight (1.4%) or underweight (0.3%).
COMMENT: The issues of schoolyard teasing, victimization, and exclusion are complex. This study identifies biases about weight that may be present in all age groups, including adults. The ability to measure and understand any bias is an important step toward creating an environment that provides emotional support while encouraging a healthy lifestyle. Screening for bullying, feelings of exclusion, and depression is recognized as an important part of each well visit for school-aged children. If discovered, we need to make sure people in the child's life are aware. We should follow the American Academy of Pediatrics recommendations to advocate for bullying awareness by teachers, education administrators, parents, and children, and support the adoption of evidence-based prevention programs in schools and other settings.
CITATION(S): Skinner AC et al. Implicit weight bias in children age 9 to 11 years. Pediatrics 2017 Jul; 140:e20163936.

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Mol Psychiatry 2017 Jun 13
Prenatal Fevers Increase Risk for Autism
The risk increased with any second-trimester fever and was highest when mothers had three or more fevers after 12 weeks, according to a population-level study.
Prenatal immune activity and infections are associated with a heightened risk for autism spectrum disorder (ASD; NEJM JW Psychiatry Apr 2013 and Mol Psychiatry 2014; 19:259; J Autism Dev Dis Dec 2015; 45:4015). To see whether fevers, from any cause, affected risk, researchers followed a Norwegian mother-child cohort (≈96,000 children born 1999–2009) through 2014 (mean age, 9 years). Mothers completed questionnaires about fevers and antipyretic use at gestational weeks 17 and 30 and at 6 months postpartum; children were screened for ASD at ages 3, 5, and 7 years. Children with positive screens had in-person assessments. About 580 children (0.6%) were identified as having ASD (some from the screen and some from medical registries).
Risks for ASD were raised with any prenatal fever (odds ratio, 1.4) and with ≥3 fevers any time after 12 weeks (OR, 3.1), compared to ASD without prenatal fevers. Prenatal acetaminophen use showed a trend toward lowered risk, but use of nonsteroidal anti-inflammatory drugs was too infrequent for its impact to be analyzed.
COMMENT: These data provide a clinical dilemma. Although treating fevers with acetaminophen seems reasonable, this drug is associated with brain toxicity in preclinical studies (Toxicol Sci 2014; 138:139).
This publication adds to the burgeoning number of studies of prenatal risk factors for autism. For example, Google Scholar lists >48,000 citations for the search term “autism prenatal risk” (accessed 6/20/2017). Mothers of children with ASD are often avid consumers of various Internet and print media and thus are highly likely to learn about any prenatal risks they were exposed to. Such knowledge may be accompanied by a belief that they “caused” their child's autism and, by intense feelings of guilt. Out of shame, parents may not mention their guilt. Therefore clinicians should assess for guilty feelings and intervene when they are present.
CITATION(S): Hornig M et al. Prenatal fever and autism risk. Mol Psychiatry 2017 Jun 13; [e-pub].
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JAMA Pediatr 2017 Jul
Concussion in Adolescent Girls Is Associated with Irregular Menses
Menstrual abnormalities were more common among adolescent girls and young women after sport-related concussion than after non-head orthopedic injuries, suggesting a connection between concussion and the hypothalamic-pituitary-ovarian axis.
Neuroendocrine disorders from traumatic brain injury have been reported in adults, including menstrual dysfunction in women. These findings raise the question of whether adolescent girls and young women may experience menstrual problems after concussion. To find out, researchers prospectively enrolled 128 girls and young women (aged 12–21 years) from two sports medicine clinics who had experienced either a sports-related concussion (N=68) or a non-head orthopedic injury (N=60).
Eligibility requirements included being ≥2 years post menarche and having regular periods during the previous year. Participants completed weekly surveys about menstrual bleeding for up to 120 days after enrollment. Menstrual dysfunction, the primary outcome, was defined as at least two abnormal bleeding patterns (intermenstrual interval <21 or >35 days, or bleeding duration <3 or >7 days) at least twice during follow-up.
Participants in the concussion group were slightly younger and more likely to have suffered previous concussion. Menstrual dysfunction during follow-up was more common in the concussion group than the non-head orthopedic injury group (23.5% vs. 5.0%; odds ratio 5.85). Specifically, participants with concussion had higher risk for intermenstrual interval <21 days (OR, 5.60) and bleeding duration <3 days (OR, 2.30).
COMMENT: As awareness of the frequency and consequences of concussions grows, pediatricians will continue to expand the list of complications to assess for after traumatic brain injury. Questioning adolescents and young women who have suffered concussions about changes in menstrual patterns will allow for appropriate referral for menstrual dysfunction and should become usual practice in all pediatric healthcare settings.
patterns in adolescent and young women. JAMA Pediatr 2017 Jul 3; [e-pub].
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Menopause 2017 Jul; 24:728
North American Menopause Society Updates Its Position Statement on
Hormone Therapy: 2017

Reaffirmation of HT's efficacy for managing vasomotor symptoms and genitourinary syndrome of menopause.
Sponsoring Organization: The North American Menopause Society (NAMS)
Target Population: Women's healthcare providers
Background and Objective
Moderate to severe vasomotor symptoms (VMS) affect a high percentage of peri- and postmenopausal women. VMS may persist for many years, negatively affecting quality of life. Genitourinary syndrome of menopause (GSM) is also highly prevalent and may become more bothersome as women age. Using an evidence-based approach, an advisory panel of >20 experts updated the hormone therapy (HT) guidelines of the NAMS. Highlights include the following important clinical points.
Key Recommendations
Vasomotor Symptoms

Genitourinary Syndrome of Menopause

Premature Ovarian Insufficiency (POI)

Bone Loss

COMMENT: The 2017 NAMS position statement reaffirms that HT is an effective treatment for both VMS and GSM. For management of VMS, my first-line HT regimen is a transdermal estradiol 0.037-mg patch plus a progestin taken either cyclically or continuously if the woman has a uterus. For women who do not have a uterus, I prescribe estrogen without progestin. Some observational evidence indicates that transdermal estradiol is associated with lower risk for venous thromboembolism compared with standard doses of oral estradiol. For GSM, my first-line HT option is a 10-µg vaginal estradiol tablet twice weekly. The FDA should remove or revise the current warning label for topical low-dose vaginal hormone products.
Note to Readers: Andrew Kaunitz, MD, Editor in Chief of NEJM Journal Watch Women's Health, served on the NAMS advisory panel but had no role in the selection or editing of this Guideline Watch.
CITATION(S): North American Menopause Society.The 2017 hormone therapy position statement of The North American Menopause Society. Menopause 2017 Jul; 24:728.
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Hepatology 2017 Jun 6 2011 Aug 8/22; 171:1363
Fecal Microbiota Transplant for Recurrent Hepatic Encephalopathy
Pilot data show promise for this treatment.
Hepatic encephalopathy (HE) is a common complication of cirrhosis. Standard-of-care (SOC) treatments, including lactulose and rifaximin, are sometimes ineffective. It has been suggested that HE is due to microbial dysbiosis, and studies show that patients with HE have a relative dearth of beneficial short-chain fatty acid–producing biota and enrichment of pathogenic Enterobacteriaceae. In the current open-label randomized study, researchers evaluated the use of fecal microbiota transplantation (FMT) from a single rationally identified (i.e., using microbiome data) stool donor in patients with cirrhosis and recurrent HE.
Twenty patients were randomized in a 1:1 ratio to SOC alone or SOC plus 5 days of pretreatment broad-spectrum antibiotics followed by a single FMT enema from a single donor. Patients were followed for 5 months. The primary endpoint was safety based on FMT-related serious adverse events. A secondary endpoint was improvement in cognition. At baseline, both groups were similar in terms of demographics, past HE history, and liver function.
The FMT group had a significantly lower rate of serious adverse events compared with the SOC-only group (20% vs. 80%), and none were FMT related. Furthermore, during the follow-up period, none of the FMT patients developed HE, compared with five (50%) in the SOC-only group (P=0.03). There was improvement in cognition from baseline in the FMT group but not the SOC-only group.
COMMENT: This small proof-of-principle study shows promise in the use of FMT for recurrent HE by targeting the microbial dysbiosis seen in this population. It appears to be safe and potentially effective. Issues that still need to be addressed in subsequent larger confirmatory studies include durability of treatment response and ascertainment of which patients with HE should be considered for FMT.
CITATION(S): Bajaj JS et al. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology 2017 Jun 6; [e-pub].

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