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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 26, 2014

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No Effect of Vitamin D Supplements for Fall Risk
Alopecia Areata and Hidradenitis Suppurativa: The Vitamin D Connection
To Stop Overtreatment, a Lab Withholds Results
Group Calling for Testosterone Study to be Retracted
New Insights into Male Breast Cancer
Sublingual Immunotherapy Approved for Grass Allergies
Early Introduction of Complementary Foods Reduces Risk for Allergic Disease at Age 6 Years
Kids with IBS Face Four Times the Risk of Celiac Disease
FDA Advisors back New Inhaled Insulin
Codeine Still Prescribed for Kids in the ER
ACOG: Induced Labor Does Not Appear to Cause Autism
E-Cigarette Injuries on the Rise

MM: One of the problems with this analysis is that there was no consistency of dose administered or blood level achieved. This is a common problem with this type of study or analysis thus making the results close to worthless and in fact potentially damaging by discouraging the utilization of vitamin D3 supplementation. I find the earlier British studies in teenagers and pre-teens to be much more reliable that demonstrated the improved physical response and diminished recovery time associated with the quintile of participants with higher vitamin D blood levels compared to those with the lowest levels.
No Effect of Vitamin D Supplements for Fall Risk
By Kelly Young
Vitamin D supplementation does not appear to reduce the risk for falls in older adults, a trial sequential analysis in the Lancet Diabetes & Endocrinology finds. This is contrary to guidance from the U.S. Preventive Services Task Force.
Nearly 30,000 older adults participated in 20 randomized trials that looked at the effect of vitamin D supplementation — with or without calcium — on the risk for falls. Vitamin D supplementation did not reduce the incidence of falls by 15% or more (the pre-specified threshold for clinical relevance). Calcium also had no effect.
The authors write that there is "little justification" for using vitamin D for fall prevention. Commentators conclude that until a large trial is conducted among adults who are particularly vulnerable to falls, "we are left with uncertainty about the benefits of vitamin D supplementation for reduction in fall risk."
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MM: We have looked for reasons that PUVA or light exposure has been beneficial for patients with variouys skin conditions and now this study provides some legitimate data and support for those treatments.
Br J Dermatol 2014 Mar 5
Alopecia Areata and Hidradenitis Suppurativa: The Vitamin D Connection
Patients with certain autoimmune disorders of the skin should be screened for vitamin D deficiency.
Unquestionable evidence demonstrates that vitamin D prevents osteoporosis. But vitamin D receptors are expressed on many cell types, not just those necessary for bone health, lending credence to the theory that vitamin D contributes to the physiology of normal tissue, and its dysregulation encourages several pathological processes, including cancer, autoimmunity, diabetes, and cardiovascular disease. Vitamin D receptors reside on keratinocytes in the epidermis and in hair follicle cells, where they promote epidermal differentiation and follicle growth.
One group of investigators evaluated the relationship between circulating vitamin D levels and alopecia areata (AA). They compared wintertime serum levels in 86 patients with various stages of AA, 44 vitiligo patients, and 58 healthy controls. Over 90% of AA patients were vitamin D deficient (defined as <20 ng/mL), compared with 71% of vitiligo patients and 33% of healthy controls. Mean ±SD vitamin D levels were 11.84 ± 6.18 ng/mL in AA patients, 16.15 ± 7.93 ng/mL in vitiligo patients, and 23.57 ± 9.03 ng/mL in healthy controls. These results were statistically significant. Extent of AA involvement and vitamin D level were in significant negative correlation.
Another group evaluated vitamin D level at various times of year in 16 patients with hidradenitis suppurativa. Ten were found to have vitamin D levels <12 ng/mL.
Comment: Vitamin D deficiency has been noted in other autoimmune diseases (e.g., systemic lupus erythematosus, autoimmune thyroiditis, pernicious anemia, and pemphigus vulgaris). It is not surprising to find it in alopecia areata and vitiligo as well. By what mechanism vitamin D deficiency affects these diseases is unknown. It is important to note that the presence of vitamin D deficiency does not necessarily imply cause and effect, but these findings raise the intriguing possibility that such deficiency contributes to these processes and could interfere with the efficacy of some treatments. Patients with alopecia areata, vitiligo, and hidradenitis suppurativa should probably be screened for vitamin D deficiency, which is easily corrected with supplements and may prevent osteoporosis
Citation(s): Aksu Cerman A et al. Vitamin D deficiency in alopecia areata. Br J Dermatol 2014 Mar 21; [e-pub ahead of print].
Kelly G et al. Vitamin D status in hidradenitis suppurativa. Br J Dermatol 2014 Mar 5; [e-pub ahead of print].
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MM: I have always liked the adage, "An ounce of prevention is worth a pound of cure. In this case, the pound of cure was nothing but smoke and mirrors. I am not a great proponent of deception but apparently sometimes that is the best way to effect change in allopathic medical treatments.
Clin Infect Dis 2014 Apr 1; 58:980
To Stop Overtreatment, a Lab Withholds Results
Without easy access to urine culture results, treatment rates plunged for patients with asymptomatic bacteriuria.
Evidence clearly indicates that patients with asymptomatic bacteriuria should not be treated (other than those who are pregnant or about to undergo invasive genitourinary tract procedures). And yet, studies show that many patients with the condition continue to receive antibiotics.
In hopes of modifying irrational prescribing behavior, researchers changed the way in which the microbiology lab in a single Toronto hospital reported results of urine cultures. All urine cultures were processed as usual, but, during two nonconsecutive months, culture results obtained from noncatheterized patients were not posted to medical records. Instead, clinicians saw a reminder that bacteriuria in asymptomatic noncatheterized patients usually does not indicate infection; clinicians were invited to call the microbiology lab if they still wanted details on specific cultures.
Compared with months during which all cultures were reported out as usual, during the study months treatment rates for asymptomatic bacteriuria among noncatheterized patients (most of whom were older women) fell from 15 of 31 (48%) to 4 of 33 (12%), whereas treatment rates among catheterized controls remained stable at about 40%. No noncatheterized patient with a urinary tract infection went untreated (most received empirical antibiotics before culture results were available), and no clinical harms befell any patient who went untreated.
Comment: The temptation to act on information can be overwhelming. This study confirms that removing the information often removes the temptation. It is an effective technique, if a little dishonest (editorialists call it “asymmetric paternalism”). I suspect we will be all seeing more of this kind of behavioral modification tool in the future.
Citation(s): Leis JA et al. Reducing antimicrobial therapy for asymptomatic bacteriuria among noncatheterized inpatients: A proof-of-concept study. Clin Infect Dis 2014 Apr 1; 58:980.

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MM: The recent data claiming the extreme danger of testosterone supplementation to men may have been grossly exaggerated. I am looking forward to seeing the legitimate data come to the fore. There is no doubt that the class action attorneys will be disappointed.
Group Calling for Testosterone Study to be Retracted
The Androgen Study Group, a large group of physicians and researchers, is calling for the retraction of a paper linking testosterone and cardiovascular risks. The group states that the study's credibility was compromised by at least two corrections and should be pulled from the journal; there appears to be no misconduct, no one faked any data, it's just sloppy and has been called gross data mismanagement. The paper was published in JAMA in November by Michael Ho, MD, PhD, of the Eastern Colorado VA, and colleagues. Two corrections have since been published; first was a clarification that the results were based on Kaplan-Meier estimates and not raw data and the second involved reclassification of patients who were excluded from the study.
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MM: Male breast cancer (MBC) appears to be somewhat on the rise. This may largely be attributed to the general increase in population weight, low vitamin D3 levels and exposure to environmental agents that mimic estrogens in the body such as pesticides, fertilizers, various petroleum and numerous plasticized products. It may be close to impossible to avoid some of these dangers but when we have potential control over others it makes sense to exert some control over those. This would include weight control and vitamin D levels in the body. Simple supplementation may be the easiest and possibly the most effective action that a person can take.
J Natl Cancer Inst 2014 Feb 19
New Insights into Male Breast Cancer
Hormonal risk factors contribute significantly to risk for developing MBC.
An international consortium of investigators, the Male Breast Cancer Pooling Project, was initiated to develop a more robust dataset on the epidemiology of male breast cancer (MBC), a relatively rare disease compared with female breast cancer. Most male breast cancer studies are small in size, retrospective, and have other limitations. Prior reports have shown many similarities to female breast cancer, including a link between obesity and elevated risk for the disease. Other hormonally influenced conditions, including gynecomastia and Kleinfelter syndrome, have also been linked with MBC, and less well-characterized associations with cirrhosis and diabetes have been observed. In addition, BRCA mutations have long been linked with increased risk for MBC.
A total of 2405 case patients (median age, 66.0 years; white race, 85.7%) and 52,013 controls were assembled from 21 studies (1190 patients and 4531 controls from case-control studies and 1215 patients and 47,482 controls from cohort studies).
Risk for developing MBC was significantly associated with weight (highest vs. lowest tertile: odds ratio, 1.36), height (OR, 1.18), and body-mass index (OR, 1.30). As in other studies, Klinefelter syndrome was strongly associated with MBC (OR, 24.7), as was gynecomastia (OR, 9.78). Diabetes also emerged as an independent risk factor (OR, 1.19). Interestingly, in contrast to female breast cancer, fractures in older males may be associated with a greater risk for MBC.
Comment: These findings support hormonally driven factors as contributing significantly to risk for developing male breast cancer. In men, obesity is associated with high estrogen levels as well as low testosterone and sex hormone-binding globulin levels, leading to greater estrogen bioavailability and a high estrogen/testosterone ratio. Similarly, Kleinfelter syndrome has been associated with high estrogen and low testosterone levels. Diabetes emerging as a risk factor may be a surrogate for obesity. The finding that fractures in older individuals are a risk factor may also suggest lower testosterone levels relative to estrogen bioavailability in men. Although the Male Breast Cancer Pooling Project investigators acknowledge the limitations of a pooling analysis of studies, including variability in exposure data and self-reporting, the results clearly point to the influence and importance of the estrogen/androgen balance as a critical factor in the development of MBC.
itation(s): Brinton LA et al. Anthropometric and hormonal risk factors for male breast cancer: Male Breast Cancer Pooling Project results. J Natl Cancer Inst 2014 Feb 19; [e-pub ahead of print].
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MM: It seems that the current theme for new meds is "ease of use". The use of sublingual tablets/pellets, dissolvable sheets and nasal sprays that all avoid the intestinal tract and the first pass effects of the liver appear to be leading the charge of new and innovative products being brought to market. It might be a good idea to keep an eye out for the companies who are developing these user-friendly technologies.
Sublingual Immunotherapy Approved for Grass Allergies
By Kristin J. Kelley
The FDA has approved the first sublingual allergen extract to treat rhinitis — with or without conjunctivitis — caused by grass pollens. The once-daily tablet (Oralair) is indicated for patients aged 10 to 65 years.
The drug contains a mix of five grass pollens: Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy. In studies among some 2500 patients, those taking Oralair had a 16% to 30% reduction in symptoms compared with those on placebo.
The first dose should be administered in a clinician's office (before the start of the grass pollen season) so that the patient can be observed for adverse reactions. The prescribing information includes a boxed warning about potentially life-threatening allergic reactions (e.g., anaphylaxis). The most common side effects include itching and swelling in the mouth, and throat irritation.
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MM: Providing a wider variety of foods to toddlers has been demonstrated to improve food tolerances however provision of foods too early has demonstrated just the opposite in other studies. It is important to find that critical balance in all that we do.
J Allergy Clin Immunol 2014 Apr; 133:1056
Early Introduction of Complementary Foods Reduces Risk for Allergic Disease at Age 6 Years
In a prospective study, more food diversity was associated with greater benefit.
Previous guidelines recommended delaying the introduction of allergenic foods to infants in hopes of preventing food allergy and other allergic disease. This practice has been called into question as rates of food allergy increase in western countries. Recent guidelines now recommend earlier introduction (ages 4-6 months) of all foods (NEJM JW Pediatr Adolesc Med Feb 20 2013). Researchers prospectively examined the association between the introduction of food during the first year of life and development of allergic disease by age 6 years in a birth cohort of 856 rural European newborn infants.
Half the children grew up on farms and half had at least one atopic parent. Food diversity was measured by the number (0-6) of common foods that were introduced during the first year: vegetables or fruits, cereals, bread, meat, cake, and yogurt. Consumption of egg, nuts, and fish were also recorded. Increasing food diversity was inversely associated with reduced risk for asthma, food allergy, and food sensitization up to age 6 years. Children introduced to fewer than four common foods during the first year had more than three times the risk for asthma and more than four times the risk for food allergy, compared with children introduced to all six foods. Fish, egg, and dairy consumption during the first year were associated with >50% reduction in food allergy, and dairy and egg consumption were associated with >50% reduction in asthma. Children with greater food diversity had evidence of greater gene transcription for regulatory T-cells associated with tolerance.
Comment: This study provides further evidence that early introduction of complementary foods prevents allergic disease. We should still recommend exclusive breast milk during the first 4 months of life but then encourage food diversity during the remainder of the first year. Children who have eczema or a sibling with food allergy remain at high risk for food allergy regardless of the age foods are introduced, so pediatric clinicians should discuss this risk with parents.
Citation(s): Roduit C et al. Increased food diversity in the first year of life is inversely associated with allergic diseases. J Allergy Clin Immunol 2014 Apr; 133:1056.
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MM: Many of the children in this study exhibited general dyspepsia that could easily have been associated with dysbiosis or food sensitivities. Many of these children could likely have been treated with probiotics and digestive enzymes. Mark Drugs has a product that is a chewable digestive enzyme and probiotic combination that is palatable and effective for many patients. It is called Heart Burn Away. There have been numerous patients of all ages who have virtually eliminated their IBS symptoms or dyspepsia with this product. It is important to re-populate the gut with friendly bacteria and when this is accomplished then symptoms are frequently eliminated.
Kids with IBS Face Four Times the Risk of Celiac Disease
By Amy Orciari Herman
Children who meet clinical criteria for irritable bowel syndrome are four times as likely to have celiac disease as the general population, according to a JAMA Pediatrics article.
Researchers studied nearly 800 Italian children aged 4 to 16 years who were referred for recurrent abdominal pain over a 6-year period. Of these, 35% met Rome III criteria for IBS, 26% for functional dyspepsia, and 40% for functional abdominal pain. Roughly 4% with IBS were diagnosed with celiac disease (based on antibody screening and confirmatory endoscopy) — significantly higher than the 1% previously reported in the general pediatric population. Under 1% of children in the other two groups were diagnosed with celiac disease.
The authors write: "This finding reinforces the utility of the Rome III criteria in classifying children with chronic abdominal pain in order to select those who deserve to be screened for celiac disease, to increase the case finding strategy, and to contain health costs." Editorialists stress the importance of "selective" screening, given the potentially high false-positive rate.
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MM: Inhaled insulin is a nice easy administration modality but in the past it has been unreliable for the management of stabilizing blood glucose. Inhaled insulin has, however demonstrated benefits for other conditions such as Alzheimer's and senile dementia. http://blog.alz.org/inhaled-insulin-for-alzheimer%E2%80%99s-disease-phase-ii-clinical-trial-results/
FDA Advisors back New Inhaled Insulin
By Kelly Young
An advisory committee to the FDA has voted to recommend approval of Afrezza, a new inhaled form of insulin for types 1 and 2 diabetes, the New York Times reports.
The Times says that the votes were surprising, given the FDA's own critical review of the drug. In clinical trials, lung cancer diagnoses were more common among patients receiving Afrezza than in the comparator group, but the absolute numbers were small.
Pfizer's inhaled insulin drug, Exubera, which was pulled from the market in 2007 for low sales, also carried an increased lung cancer risk. The Exubera inhaler was roughly the size of a tennis ball can. The Afrezza inhaler, meanwhile, can fit in the palm of the hand.
MannKind, which developed Afrezza, says that its insulin takes effect faster than rapid-acting injected insulin. The FDA could decide whether to approve the drug by the middle of April.

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MM: The question of why do doctors continue to order Codeine for pediatrics in ER settings is simple. Virtually everything else on the market has been eliminated to treat cough symptoms. If physicians had viable alternatives then they would likely order other products. Until that occurs, we continue to see the misuse of codeine in pediatric patients.
Codeine Still Prescribed for Kids in the ER
By Kelly Young
Children presenting to U.S. emergency departments with cold and upper respiratory infections are still receiving prescriptions for codeine, despite guidelines recommending against this practice, according to a Pediatrics study.
Researchers analyzed data from 56,000 children (aged 3 to 17 years) seeking care in emergency departments from 2001 to 2010.
Although the proportion of visits in which codeine was prescribed for any cause decreased from 3.7% to 2.9% over 10 years, prescriptions for cough and upper respiratory infections didn't significantly change after 2006, when guidelines from several medical societies recommended against codeine's use for this indication.
Both the authors and editorialists recommend that hospital formularies remove codeine. The editorialists conclude: "There may be reasons why clinicians are still attached to the use of codeine in everyday practice; and they will howl with dismay when it is gone. But we must find novel ways to convince them that there is a need to change and that the time to retire this drug is today."
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MM: Until additional data of a better quality is available, I wouldn't throw out this hypothesis for autism spectrum disorder conditions. It is certainly not the only cause of autism but may be a mitigating or even a contributing factor in a specific subset of patients. We simply do not know enough to eliminate potential causes such as labor induction.
ACOG: Induced Labor Does Not Appear to Cause Autism
By Kelly Young
There is no causal relationship between labor induction or augmentation and the development of autism spectrum disorders, the American College of Obstetricians and Gynecologists (ACOG) concludes. Previously, researchers had proposed that synthetic oxytocin used for induction and augmentation could change oxytocin receptors in the fetus and predispose these children to autism.
A 2013 study found an increased risk for autism in children who were born by induced or augmented labor, but ACOG pointed to several weaknesses in that study. For instance, the researchers did not know which agents were used for induction or augmentation. The study also had missing data on potential confounders.
In addition, the ACOG authors write, reducing labor induction or augmentation could increase the cesarean rate.
Given these limitations and potential unintended consequences, ACOG "recommends against a change in current guidance regarding counseling and indications for and methods of labor induction and augmentation."

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MM: The FDA needs to take a closer look at products made in China and India as there have been numerous incidences of injury associated with products such as these. we have to be vigilant as consumers as well and realize that the most inexpensive product may end up costing much more if it is an inferior or dangerous product.
E-Cigarette Injuries on the Rise
By Amy Orciari Herman
Over 50 complaints of electronic cigarette injuries were made to the FDA between March 2013 and March 2014 — roughly equivalent to the number seen in the preceding 5 years combined — Reuters reports.
Complaints included difficulty breathing, headache, cough, dizziness, sore throat, nose bleeds, chest pain, and allergic reactions. One woman noted that her young son's voice had been raspy since his father started using the devices. In addition, one consumer reported that an e-cigarette "blew up in my mouth while inhaling, burning my ... gum, lip and fingers," while another blamed the devices for blackened taste buds.
The director of the FDA's Office of Science called the increase in injuries significant, according to Reuters, noting that poison control centers have also seen a rise in e-cigarette-related calls.
Most e-cigarettes are made in China, and the quality is inconsistent, the story notes.

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