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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 27, 2016

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Does the Gut Microbiome Play a Role in Neuromyelitis?
Reasons for High U.S. Drug Prices (Hint: It's Not Development Costs)
New Menopause Guidelines Update Hormone Therapy Safety Evidence (2016)
Estrogen-Containing Contraception may Boost Vitamin D Levels
Do Certain Postpartum Contraceptives Cause Depression?
Breast Density, Cancer Risk Could Be Used To Tailor Mammogram Frequency,
   Study Suggests
EpiPen Costs Lowered for Some
Migraine in Kids Linked to Functional GI Disorder
Elevated Lipids Are Associated with Lower Diabetes Risk: More Proof
Adipose Mesenchymal Stem Cells Are Effective for Complex Perianal Fistulas in
   Crohn Disease
Live Attenuated Flu Vaccine Offers No Extra Community Benefit
Preventing Obesity and Eating Disorders in Adolescents
Normal BMI Lowers Risk for Most Cancers, IARC Says
Concussion Evaluation Tests Cleared for Marketing
AHA Recommends Limit of 6 Tsp. Added Sugar per Day for Kids & Teens

Ann Neurol 2016 Jul 11
Does the Gut Microbiome Play a Role in Neuromyelitis?
Clostridium perfringens is more common in patients with NMO compared with MS patients and healthy controls.
Noting some homology in the T-cell epitope to aquaporin-4 in neuromyelitis optica (NMO) and a sequence within Clostridium perfringens, researchers postulated a potential role for immune dysregulation in NMO susceptibility. To investigate further, they analyzed stool samples from 16 patients with NMO, 16 healthy controls (HC), and 16 patients with multiple sclerosis (MS) using a probe to bacteria taxonomic differences.
The abundance of 829 operational taxonomic units differed between the NMO and control groups, of which 42 were significant after statistical correction for multiple comparisons. (No differences between the MS and control groups were significant.) C. perfringens was the second most statistically enriched taxon in NMO versus in HC.
COMMENT:  In this interesting pilot study, differences in gut flora were noted between NMO and controls after accounting for differences in immunosuppression. NMO is a rare disease, and perhaps C. perfringens is a permissive step in the cause of NMO or in the immune dysfunction that follows. Additional studies are needed to investigate cause and effect. Larger studies are needed in NMO and other autoimmune diseases to confirm a role of bacterial gut flora on disease susceptibility and severity.
CITATION(S): Cree BAC et al. Gut microbiome analysis in neuromyelitis optica reveals overabundance of Clostridium perfringens. Ann Neurol 2016 Jul 11; [e-pub].
Definition: Neuromyelitis optica (NMO), also known as Devic's disease or Devic's syndrome, is a heterogeneous condition consisting of the simultaneous inflammation and demyelination of the optic nerve (optic neuritis) and the spinal cord (myelitis). It can be monophasic or recurrent.
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Reasons for High U.S. Drug Prices (Hint: It's Not Development Costs)
By Joe Elia, Edited by David G. Fairchild, MD, MPH
Drug companies' protestations that their high prices stem from the costs of development don't hold up under scrutiny, a JAMA analysis asserts.
The analysts reviewed clinical, regulatory, and legislative documents from the past decade to investigate factors contributing to U.S. drug costs — the world's highest.
They assign blame to two major factors: protection from competition by manufacturers of generic versions and prohibitions against negotiating lower prices. Also at fault are government-granted monopoly rights for new drugs and legal (and chemical) maneuverings to extend those monopolies.
The authors find "little evidence of an association between [R&D] costs and drug prices." Here in the U.S., they say, pricing is based on "what the market will bear."
(In related news, the New York Times noted the six-fold increase over the past decade in the price of Mylan's EpiPen, the epinephrine self-injection device for life-threatening allergic reactions.)
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New Menopause Guidelines Update Hormone Therapy Safety Evidence (2016)
Hormone therapy (HT) continues to be the most effective treatment for menopause symptoms according to updated guidelines on managing women's overall midlife health from the International Menopause Society (IMS).
Since the risk-benefit ratio differs for perimenopausal women compared with older, postmenopausal women, "[Menopausal HT (MHT)] must be individualized and tailoredaccording to symptoms and the need for prevention, as well as personal and family history, results of relevant investigations, the woman's preferences and expectations," write Rodney J. Baber, MD, from the University of Sydney in Australia, and colleagues from the IMS Writing Group.
The recommendations update the previous ones issued in 2013 but with several new features: grades for the recommendations, levels of evidence, and "good practice points." "New data and re-analyses of older studies by women's age show that, for most women,the potential benefits of MHT given for a clear indication are many and the risks are fewwhen initiated within a few years of menopause."
"These recommendations give enough evidence to almost give providers 'permission' to recommend [HT] to help women who are suffering because many practitioners have been hesitant," Dr Makai, director of minimally invasive gynecologic surgery for the Department of Obstetrics and Gynecology, Christiana Care Health System, Wilmington, Delaware, explained. "The evidence for HT is so broad, and the way it affects women is so vast, that it's really difficult for a provider who is evidence-based, but not at a major academic center, to keep up with the guidelines."
Climacteric. 2016; 19: 109-150. Published online June 20, 2016. 
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J Clin Endocrinol Metab 2016 Aug 4
Estrogen-Containing Contraception may Boost Vitamin D Levels
For women discontinuing estrogen-containing contraceptives to attempt pregnancy, clinicians should consider advising use of multivitamins containing vitamin D and folic acid.
Vitamin D deficiency is common among U.S. women: Overall, about 42% have levels below the threshold of 20 ng/mL for 25-hydroxyvitamin D (25[OH]D) recommended by the Institute of Medicine, and a higher proportion of non-Hispanic black women (80%) fall below this threshold. Using cross-sectional data from 1662 black women (age range, 23–34) in the Detroit, Michigan area, investigators estimated percent change in season-adjusted serum levels of 25(OH)D in relation to estrogen use after adjustment for many factors.
The overall median level of 25(OH)D was 15.7 ng/mL, and 70% of participants had levels <20 ng/mL. Women using estrogen-containing contraceptives had a median 25(OH)D level of 19.4 ng/mL, but 49% of them also used a supplement that contained vitamin D (in all, about 40% of women took supplements containing vitamin D). Although supplement use was the strongest predictor of 25(OH)D levels, the final adjusted model indicated an independent 20% increase in 25(OH)D levels among women using estrogen-containing contraceptives. The percent increase in 25(OH)D levels was similar regardless of ethinyl estradiol dose (range, 10–35 µg).
COMMENT: Studies of vitamin D are complicated by difficulties in accurately measuring serum 25(OH)D. The authors acknowledge that their immunoassay underestimated 25(OH)D concentrations compared with the gold-standard assay (which is based on liquid chromatography); nonetheless, their assay placed individuals in the appropriate order across the range of values commonly present. They suggest that women who discontinue estrogen-containing contraceptives to become pregnant may have falling 25(OH)D levels that could negatively affect any resulting pregnancy. Thus, vitamin D supplementation (e.g., in the form of a daily multivitamin that also contains folic acid) should be advised for those pursuing childbearing.
CITATION(S): Harmon QE et al. Use of estrogen-containing contraception is associated with increased concentrations of 25-hydroxy vitamin D. J Clin Endocrinol Metab 2016 Aug 4; [e-pub].
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J Fam Plann Reprod Health Care 2016 Jul; 42:171
Do Certain Postpartum Contraceptives Cause Depression?
Injectable contraception may raise risk for postpartum depression.
In many settings, depot medroxyprogesterone acetate (DMPA) is commonly offered postpartum for contraception. To evaluate the effects of DMPA on risk for postpartum depression, South African researchers randomized 242 women (87% of whom had previously used DMPA) to receive DMPA or a copper intrauterine device within 48 hours of delivery. At 1 and 3 months postpartum, participants completed the Beck Depression Inventory (BDI-II) and the Edinburgh Postnatal Depression Scale (EPDS).
At 1 month postpartum, median EPDS scores — but not BDI-II scores — were significantly higher among women who received DMPA. At 3 months postpartum, median BDI-II scores — but not EPDS scores — were significantly higher among women who received DMPA. At 1 and 3 months, no significant between-group differences in number of women with EPDS scores ≥12 were observed (scores ≥10 indicate possible depression). In addition, no significant differences occurred in the number of women with BDI-II ≥14, although at 3 months, 8 of 113 women who received DMPA versus 2 of 117 who received a copper IUD (P=0.05) had BDI-II scores ≥29 (indicating severe depression).
COMMENT: The authors note that the BDI-II and the EPDS have different foci as screening tools, which may explain the apparent inconsistencies in outcomes. As they conservatively conclude, they cannot rule out the possibility that immediate postnatal DMPA use is associated with depression. Until further evidence becomes available, subdermal contraception (which can be promptly removed if depressive symptoms appear) offers a highly effective alternative.
CITATION(S): Singata-Madliki M et al. The effect of depot medroxyprogesterone acetate on postnatal depression: A randomised controlled trial. J Fam Plann Reprod Health Care 2016 Jul; 42:171.

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Breast Density, Cancer Risk Could Be Used To Tailor Mammogram Frequency, Study Suggests
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Average-risk women with low breast density might be able to undergo less frequent screening mammograms, according to a modeling study in the Annals of Internal Medicine. The U.S. Preventive Services Task Force currently recommends biennial screening mammography for average-risk women aged 50–74.
Researchers used simulation models to examine the benefits and harms of digital mammography at various intervals in two populations: women aged 50 starting screening for the first time, and those aged 65 who’d been receiving biennial screening since age 50. Among the findings:

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EpiPen Costs Lowered for Some
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The manufacturer of the EpiPen auto-injector is taking steps to lower costs for some patients following increasing complaints about the treatment's growing price tag. Mylan has raised the price by 15% twice a year over the past 2 years, the New York Times reports.
The company says it will now offer a $300 savings card for patients purchasing an EpiPen set at the pharmacy; previously, the company offered a savings card of $100. In addition, patients at or below 400% of the federal poverty level will qualify for free EpiPens (that is, families of four who earn $97,200/year or less).
"The new moves will probably not fully mollify the critics," the Timesspeculates. "For one thing, Mylan is not lowering the list price of EpiPen, just making it easier for consumers to pay for it. So insurance companies, federal health programs like Medicare and Medicaid and school districts that stock the products could still pay the same price."
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Migraine in Kids Linked to Functional GI Disorder
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Migraine in children is associated with increased risk for functional gastrointestinal disorders, according to a case-control study in theLancet Gastroenterology & Hepatology.
Researchers studied 425 children aged 6–17 years who were diagnosed with migraine or tension-type headache in the emergency department, and 650 children who presented to the ED with minor injuries (controls). The children and their parents completed questionnaires about GI symptoms, and diagnoses of functional GI disorders were made accordingly.
Functional GI disorders were diagnosed in 32% of children with migraine, versus 18% of controls. After multivariable adjustment, migraine was associated with significantly increased risks for functional dyspepsia (odds ratio, 10.8), abdominal migraine (OR, 5.9), and irritable bowel syndrome (OR, 3.5), but with significantly decreased risk for functional constipation (OR, 0.3).
Tension-type headache was not associated with GI disorders.
The authors offer several potential mechanisms for the increased risks seen with migraine, including inflammatory mediators and serotonin activity. They say they have "no explanation" for the inverse relationship with constipation.
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JAMA Cardiol 2016 Aug 3
Elevated Lipids Are Associated with Lower Diabetes Risk: More Proof
Mendelian randomization analyses yield insights into the association, but do not address whether lowering lipids increases the risk.
Interest has been increasing in the interplay between low-density lipoprotein (LDL)-cholesterol levels and diabetes type 2, prompted in part by evidence that statin therapy moderately increases diabetes risk. To investigate associations between lipid fractions and risks for diabetes and coronary artery disease (CAD), researchers performed Mendelian randomization (MR) studies, which use genetic variants as proxies for environmental exposures. A series of genetic instruments for LDL-cholesterol, high-density lipoprotein (HDL)-cholesterol, and triglyceride (TG) levels were generated from 185 lipid-associated single nucleotide polymorphisms (based on three datasets; N=532,825).
Higher CAD risk was significantly associated with higher LDL-cholesterol; for each 1–standard-deviation (SD) genetically instrumented elevation (equivalent to 38 mg/dL), the odds ratio was 1.68. For HDL-cholesterol and TGs, the investigators used two newer MR methods to account for pleiotropy (which can systematically bias MR estimates). Only TGs were significantly associated with elevated CAD risk (equivalent to 89 mg/dL; OR per 1-SD elevation, 1.28).
Regarding diabetes, all three lipid traits were significantly associated with lower risk for type 2 diabetes. For each SD elevation in LDL-cholesterol and HDL-cholesterol, the ORs were 0.79 and 0.83, respectively. For TGs, lower diabetes risk was observed under only one MR method (OR per 1-SD elevation, 0.83), leading the authors to urge caution in interpreting these data.
COMMENT : Although randomized, controlled trials remain the gold standard for research, MR studies can remove the reverse causality and confounding of observational studies and account for lifelong exposure to risk factors. Unfortunately, because this study's datasets were confined to individuals of European ancestry, applicability to individuals of other ethnic groups is unknown. However, lifelong higher LDL-cholesterol and TG levels (but not lifelong higher HDL-cholesterol) were associated significantly with higher CAD risk. In contrast, higher levels of LDL-cholesterol and HDL-cholesterol were associated with a reduced risk of diabetes; data on TG were inconsistent. Despite these intriguing data, we cannot assume that pharmacologic lowering of lipids alters diabetes risk. Adequately powered, randomized, controlled trials are necessary to determine this for each lipid type and for each class of lipid-altering agents.
CITATION(S): White J et al. Association of lipid fractions with risks for coronary artery disease and diabetes. JAMA Cardiol 2016 Aug 3; [e-pub].
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Lancet 2016 Jul28
Adipose Mesenchymal Stem Cells Are Effective for Complex Perianal Fistulas in Crohn Disease
Half of patients had complete closure of all external openings 24 weeks after treatment with stem cells.
Adipose-derived mesenchymal stem cells were effective in improving perianal fistulas in early studies.
In a multicenter, industry-funded trial in Europe and Israel, 212 patients with complex perianal fistulas (defined as high intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric, or with at least 2 external openings, or associated collections) with ≤2 internal and ≤3 external openings were randomized to treatment with stem cells versus saline placebo. Participants were refractory to antibiotics, immunomodulators, or anti–tumor necrosis factor agents.
Randomized patients received adequate drainage and, in the majority, seton placement. Two weeks or more later, the internal opening was stitched closed. A surgeon, unblinded to the assigned treatment, then injected stem cells or placebo into the tissue surrounding the internal opening and then through the external opening into the fistula walls, along the entire tract, creating small blebs.
Blinded to treatment assignment, a gastroenterologist assessed the tracts for closure at 6, 12, 18, and 24 weeks, and a radiologist assessed a pelvic magnetic resonance imaging (MRI) scan at week 24. The primary endpoint was closure of all treated external openings and absence of any collections >2 cm on the MRI at week 24.
The primary endpoint in patients with at least one follow-up assessment was achieved in 51% of the stem-cell group versus 36% of the placebo group (difference, 15.8%; number needed to treat, 6.3). Secondary efficacy endpoints had similar differences. Adverse event rates were similar between groups. About 20% of stem cell recipients developed new HLA class 1 antibodies by week 12, but there were no immune reactions and no association between antibodies and treatment response.
COMMENT: This superbly conducted phase III trial proves that adipose-derived mesenchymal stem cells injected by a trained surgeon into properly prepared tracts of patients with Crohn disease and complex perianal fistulas are effective in improving closure rates.
CITATION(S): Panés J et al. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: A phase 3 randomised, double-blind controlled trial. Lancet 2016 Jul28; [e-pub].
(http://dx.doi.org/10.1016/S0140-6736(16)31203-X)  SHARE
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Ann Intern Med 2016 Aug 16
Live Attenuated Flu Vaccine Offers No Extra Community Benefit
Herd immunity from live flu vaccine appears to be no better than from inactivated vaccine.
Intranasal live attenuated influenza vaccine has been more immunogenic than intramuscular inactivated vaccine among children in clinical trials. This finding has led to the assumption that the live vaccine also should be a more powerful inducer of herd immunity. Canadian researchers studied the community-wide performance of both vaccines in 52 rural Hutterite colonies — tiny religious settlements composed of single-family homes and communal cooking, dining, and meeting facilities. During three influenza seasons (2012–2015), 1186 children (age range, 3–15) were randomized by colony to receive either intranasal live attenuated flu vaccine or inactivated flu vaccine in a double-blind fashion. Influenza and respiratory illness rates were tracked among both the vaccinated children and 3425 of their contacts, a negligible proportion of whom received out-of-study vaccine.
Laboratory-confirmed influenza A and B were diagnosed in 3% to 7% of all participants each season. Although absolute rates varied by region, no difference in rates could be ascribed to individual vaccine, either among vaccinated children or among their contacts. Further, no significant differences between vaccines emerged for such common surrogate markers of respiratory infection as antibiotic prescriptions, emergency room visits, hospital admissions, and work or school absentee rates.
COMMENT: These findings suggest that the more expensive live attenuated influenza vaccine offers no advantages over conventional vaccine for either vaccinated children or their community contacts. Whether vaccine performance in a group of tiny rural communities is completely generalizable to other settings is unclear, but this carefully designed study is unlikely to be duplicated successfully in larger, more chaotic environments. Meanwhile, the CDC recommends that the intranasal vaccine not be used for the upcoming flu season because of efficacy concerns.
CITATION(S): Loeb M et al. Live attenuated versus inactivated influenza vaccine in Hutterite children: A cluster randomized blinded trial. Ann Intern Med 2016 Aug 16; [e-pub].
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Pediatrics 2016 Aug 22
Preventing Obesity and Eating Disorders in Adolescents
Evidence-based guidance by pediatricians can help identify behaviors that predispose to obesity and eating disorders.
As many as one third of adolescents who seek treatment for an eating disorder previously had a weight >85th percentile. To address concerns that obesity prevention may promote development of eating disorders, the American Academy of Pediatrics has issued a clinical report.
Cross-sectional and longitudinal observational studies have shown that the following behaviors are associated with obesity and eating disorders in adolescents:

To help prevent obesity and eating disorders, the report recommends pediatricians do the following:

COMMENT: Obesity is a chronic illness that is managed best with frequent office visits to follow weight. Using the tools of motivational interviewing (http://ihcw.aap.org/resources), pediatricians can counsel patients and parents to follow the recommendations outlined above (NEJM JW Pediatr Adolesc Med May 2015 and Pediatrics 2015; 135:649).
CITATION(S): Golden NH et al. Preventing obesity and eating disorders in adolescents. Pediatrics 2016 Aug 22; [e-pub].
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Normal BMI Lowers Risk for Most Cancers, IARC Says
By Amy Orciari Herman, Edited by Richard Saitz, MD, MPH, FACP, FASAM
The International Agency for Research on Cancer now says there’s sufficient evidence that "absence of excess body fatness" lowers the risk for eight additional cancers: those of the gastric cardia, liver, gallbladder, pancreas, ovaries, and thyroid, plus multiple myeloma and meningioma. These eight join five other cancers noted by the group in 2002: those of the breast (postmenopausal), corpus uteri, esophagus (adenocarcinoma), kidneys (renal cell), and colon.
Writing in the New England Journal of Medicine, the group defines “excess body fatness” as a body-mass index of 25 or higher. Findings were based on a review of over 1000 epidemiologic studies.
Of note, positive dose-response associations between BMI and risk were found for more than half the cancer sites, with relative risks generally ranging from 1.2 to 1.5 for overweight and from 1.5 to 1.8 for obesity.
The authors also cite animal research suggesting that intentional weight loss can help prevent cancer.
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Concussion Evaluation Tests Cleared for Marketing
By Kristin J. Kelley, Edited by David G. Fairchild, MD, MPH
The FDA has approved marketing for two tests that help clinicians evaluate signs of concussion and head injury. ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing) and ImPACT Pediatric assess cognitive function by testing reaction time, word memory, and word recognition immediately after a suspected injury.
The software for the devices — indicated for use in patients 5 to 11 years (ImPACT Pediatric) and 12 to 59 years (ImPACT) — runs either on desktops and laptops, or on iPads. Test results are compared to either a patient's pre-injury baseline score or an age-matched control.
The green light for marketing was granted based on data from some 125 studies that looked at, among other things, the tests' ability to detect symptoms of cognitive dysfunction associated with concussive head injuries. An FDA official notes that "clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game."
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AHA Recommends Limit of 6 Tsp. Added Sugar per Day for Kids & Teens
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The American Heart Association now recommends that children limit their added sugar intake to 25 g daily or less, the equivalent of 6 teaspoons of sugar, or 100 calories. On average, children currently consume about 80 g daily.
The 2015–2020 Dietary Guidelines for Americans recommends that children limit their added sugar intake to less than 10% of their total calories. The new AHA scientific statement recommends a 5% limit. Among the other recommendations, published in Circulation:

The authors conclude: “Although added sugars most likely can be safely consumed in low amounts as part of a healthy diet, few children achieve such levels, making this an important public health target.”

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