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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 6, 2014

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Genes Influence Composition of the Gut Microbiome
2014-15 Flu Vaccine Not a Perfect Match for Circulating Viruses
Obesity in Young Adults May Shorten Lifespan by 6 Years
Lawmakers Looking to Reduce Rising Cost of Generic Drugs
No Evidence to Support Routine Use of Aspirin in Most Women for Primary Prevention
Experimental Artificial Pancreas Better than Insulin Pump for Type 1 Diabetes
MM: Dietary Supplements Linked to Fatal Cases of GI Mucormycosis in a Premature Infant
Is There Such a Thing as Too Much Milk?
Over Half of U.S. Infants Still Sleep in Hazardous Situations
Antibiotic Self-Stewardship Can Cut Treatment Costs

MM: This is extremely exciting as a widespread dysbiosis could be a root cause for obesity and metabolic syndrome in many people. More support will be needed for the general medical community to accept that an appropriate and targeted mix of probiotics may be the answer to this worldwide epidemic. In the meantime, if a probiotic mix such as those that are available at Mark Drugs, seems to relieve gas, bloating and a variety of other GI ills, then there may be reason to believe that this is a combination that could also lead to protection of weight and the gut for that individual as well.
Cell 2014 Nov 6; 159:789
Genes Influence Composition of the Gut Microbiome
For many bacterial taxa, the influence of human genes is much greater than environmental influences
An explosion of evidence in the past 5 years links the microbial composition of the gut to obesity in humans. Obesity also is influenced by many human genes, and the gut microbiome clearly is influenced by the environment. A multicenter team asked whether human genes might influence composition of the gut microbiome.
The team obtained more than 1000 fecal samples from monozygotic twin pairs, dizygotic twin pairs, and unrelated individuals. They determined the presence and amount of more than 9600 bacterial groupings. The microbiota of monozygotic twins were much more similar than the microbiota of dizygotic twins or unrelated people. For some bacterial groups, such as Bacteroidetes, the environmental influences were much greater than the influences of human genes. For other groups, such as Christensenellaceae, the opposite was true; this group also appeared to protect against obesity. When germ-free mice were inoculated with stool from lean humans (rich in Christensenellaceae), the mice remained lean; whereas, when germ-free mice were inoculated with stool from obese humans (poor in Christensenellaceae), the mice became obese. When Christensenellaceae was added to human stool devoid of this group, the altered stool protected against obesity.
Comment This huge study of human gut microbiota reinforces many recent studies that have demonstrated a potent effect of the gut microbiome on human obesity. In addition, it indicates that genetic inheritance of obesity might be attributable partially to the influence of human genes on the gut microbiome.
Citation(s): Goodrich JK et al. Human genetics shape the gut microbiome. Cell 2014 Nov 6; 159:789.

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MM: When the CDC tells the public that the flu vaccine does not work then in the next breath they say that all people should get the flu vaccine even though it's the wrong vaccine, it amazes me that nobody comments on the absurdity. About half of the bugs that are out there are resistant to the vaccine and on top of that, almost 90% of the bugs that the vaccine is wrong for will be the cause of sickness and death. Yet, the CDC still strongly recommends the vaccine. What am I missing here? Wouldn't people be better protected if they were instructed on the best ways to strengthen their immune systems such as Vitamins C and D and decreasing their total and relative carbohydrate intake?
2014-15 Flu Vaccine Not a Perfect Match for Circulating Viruses
By Kelly Young, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Roughly half of the circulating influenza A (H3N2) viruses collected in the U.S. early this flu season are antigenically different from the H3N2 virus included in this year's vaccine, prompting CDC officials to remind healthcare providers about using neuraminidase inhibitors to treat and prevent influenza.
H3N2 has been present in about 90% of influenza-positive tests this flu season. Years with high H3N2 activity tend to see higher flu morbidity and mortality.
The World Health Organization recommended components for the Northern Hemisphere vaccine in February. Antigenically drifted H3N2 viruses were detected in March and became more prevalent in September, too late to change the vaccine.
"They're different enough that we're concerned that protection from vaccination ... may be lower than we usually see," CDC Director Tom Frieden told reporters on Thursday.
The CDC is still recommending that people get vaccinated against the flu because it provides partial protection and the B strains are well matched. But Frieden said that if clinicians suspect influenza in high-risk patients, they should start neuraminidase inhibitor treatment without waiting for confirmatory test results.
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MM: We've heard from our doctors and in the media that being obese diminishes our quality of life and how long we will live but rarely are these statements actually fleshed out into real numbers. This article does just that. The model indicates that not only will 20-39 year olds, who are overweight or obese, live shorter lives of 2.7 to 5.9 fewer years but the number of HEALTHY years was reduced by about 6-19 years depending on the level of obesity. This means that the argument of, "if I live fewer years, at least I'm enjoying them more", won't hold up because not only will those lives be shortened but the years that they will be less comfortable and less enjoyable.
Obesity in Young Adults May Shorten Lifespan by 6 Years
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Obese young adults can expect to live about 6 years less than their normal-weight peers, according to a modeling study in the Lancet Diabetes & Endocrinology.
Researchers created and validated a model to estimate the annual risks for diabetes, cardiovascular disease, and mortality in overweight and obese adults. They then applied National Health and Nutrition Examination Survey data to some 4000 white adults to estimate life-years lost and healthy life-years lost (free of diabetes and cardiovascular disease) according to BMI.
Compared with normal-weight men aged 20–39, overweight men lived an estimated 2.7 fewer years; obese men, 5.9 fewer years; and very obese men, 8.4 fewer years. The number of healthy life-years lost was even greater: 5.9, 11.8, and 18.8, respectively. Findings generally were similar for women. Overall, the number of years lost attributable to excess weight decreased with increasing age.
The researchers say their findings "might provide a useful health measure for discussions between health professionals and their patients."
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MM: Generic drugs are supposed to lead to a cost savings and historically that cost savings resulted in the virtual elimination of the brand name products from the market place. This was due to both tiered insurance reimbursement levels and consumer response to supply and demand pressures causing the demand for the brand name products to essentially disappear. This disappearance of name brand competition and the elimination of most generic manufacturers in India have resulted in what may be a temporary blip in the generic marketplace but will more likely show a permanent net increase in the cost of almost all generic drugs that are not coming from multiple sources. This effect is likely t o spread throughout the entire generic manufacturing community if distressed generic manufacturers continue to be purchased and companies consolidated. It is my opinion that we are looking at the start of a trend that is not likely to be reversed any time soon.
Lawmakers Looking to Reduce Rising Cost of Generic Drugs
A Senate panel has been convened to investigate price increases for generic drugs. One half of generic drugs increased in price between last summer and this summer; of these, about 10% more than doubled in cost in that time and some common drugs increased by over 500% (From the Congressional hearing). The cost of many generics increased so much over the past year that prices for many common generic drugs in the U.S. have surpassed those of their brand-name equivalents in other developed countries.
As an example, a 90-day supply of digoxin sells for $187 in New York; the branded version, Lanoxin, sells for $24.30 in Canada; a month's supply of a generic steroid to treat inflammatory bowel disease sells for $1,625 in the U.S. while the branded version sells for $155.70 in Canada.
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MM: Daily prophylactic use of Aspirin will cause many more problems that are both life threatening and life tormenting than the number of lives it will save in women younger than 65. The differences between the number of patients needed to make a difference in these numbers is not small but quite wide. Based on this data, there is little reason to recommend aspirin for CV and/or colorectal protection in women under 65 unless they have a definitive family history and personal history that would pre-dispose them to these diseases.
No Evidence to Support Routine Use of Aspirin in Most Women for Primary Prevention
By Larry Husten, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
In most women, the benefits of regular aspirin use for primary prevention don't outweigh the risks, a Heart study suggests.
In the Women's Health Study, nearly 28,000 women aged 45 and older were randomized to placebo or 100-mg aspirin every other day. Aspirin use led to small reductions in 15-year absolute risks for cardiovascular disease and colorectal cancer; 371 patients need to be treated to prevent one cardiovascular event, and 709 to prevent one colorectal cancer. This small benefit occurred at the expense of an increase in gastrointestinal bleeding — 133 needed to be treated to cause one event.
In women aged 65 or older, aspirin's cardiovascular benefits were more pronounced (number needed to treat, 29). Gastrointestinal bleeding was also increased in this older group, but the CV benefit appeared to outweigh the risk.
The authors conclude that aspirin "is ineffective or harmful in the majority of women with regard to the combined risk of CVD, cancer, and major gastrointestinal bleeding." However, "selective treatment" in older women may be reasonable.
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MM: An artificial pancreas can imitate the workings of a real organ. The advent of real time micro computer monitoring and adjustment to organ output results in less end organ damage and improved control of metabolic systems. This is truly a modern technical miracle.
Experimental Artificial Pancreas Better than Insulin Pump for Type 1 Diabetes
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Artificial pancreas systems provide better glycemic control than conventional insulin pump therapy in patients with type 1 diabetes, according to a partially industry-supported study in the Lancet Diabetes & Endocrinology.
Thirty patients aged 12 years and older with good glycemic control on insulin pump therapy attended three 24-hour study visits during which they received the following: single-hormone artificial pancreas therapy (insulin only, based on glucose sensor readings and a dosing algorithm), dual-hormone artificial pancreas therapy (insulin plus glucagon), or conventional pump therapy (continuous subcutaneous insulin). All patients received all three therapies in randomized order, with 2 weeks between treatments.
The average percentage of time in the target glucose range was significantly higher with the single-hormone and dual-hormone artificial pancreas (62% and 63%, respectively) than with conventional therapy (51%). In addition, hypoglycemic events requiring oral treatment occurred in just 17% and 21% of patients during single- and dual-hormone pancreas treatment, respectively, versus 83% during pump therapy.
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MM: Nutritional products and supplements should be held to the same manufacturing standards as prescription and over the counter drugs. This is the only way to guarantee that consumers obtain what they are paying for. Even though this is not a practice that is required by law, there are companies who hold to these exacting standards. You can recognize these products by the "cGMP" label on the bottle. It means that the product has been manufactured using "current Good Manufacturing Processes."
MM: Dietary Supplements Linked to Fatal Cases of GI Mucormycosis in a Premature Infant
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
A premature infant in Connecticut died in October from gastrointestinal mucormycosis after receiving a dietary supplement contaminated with Rhizopus oryzae, the CDC reported last week. The infant, born at 29 weeks' gestation, received ABC Dophilus Powder for 4 days, beginning on day one of life.
The supplement is purported to contain probiotics and is marketed for infants and children. The CDC notes that this and other probiotics have been given increasingly to preterm babies after a recent Cochrane review supported their use for preventing necrotizing enterocolitis.
Testing of unopened bottles of ABC Dophilus Powder from the lot implicated in the infant's death revealed R. oryzae. Subsequently, the manufacturer, Solgar, Inc., recalled this lot and two others.
The CDC is advising clinicians to avoid using Solgar ABC Dophilus Powder, particularly in babies who may be especially susceptible to infection. In addition, the agency reminds clinicians considering using supplements that the FDA does not regulate these agents as drugs.
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MM: Too much of a good thing tends to end negatively and apparently excessive milk consumption is in those ranks. Humans are the only animal that regularly and voluntarily consumes the milk from another species. This old argument against excessive adult milk consumption may finally be bearing out.
BMJ 2014 Oct 28; 349:g6015
Is There Such a Thing as Too Much Milk?
In a Swedish observational study, high milk consumption was associated with excess risks for fractures and death.  
Dairy products are promoted to lower fracture risk. However, milk contains d-galactose, which induces oxidative stress and chronic inflammation in animal models and, thus, might have deleterious long-term health effects. In this observational study of 61,000 women and 45,000 men who completed food-frequency questionnaires, Swedish investigators assessed whether high milk consumption is associated with excess risk for fractures and death.
During a mean follow-up of 20 years, women who drank ≥3 glasses of milk daily (compared with those who drank <1 glass) had higher risks for all-cause death (adjusted hazard ratio, 1.9), cardiovascular-related death (HR, 1.9), cancer-related death (HR, 1.4), any fracture (HR, 1.2), and hip fracture (HR, 1.6); significant dose-response relations were observed. During a mean follow-up of 11 years, men who drank ≥3 glasses of milk daily had higher risks for all-cause death (HR, 1.1) and cardiovascular-related death (HR, 1.2). Milk consumption was associated positively with elevated urinary and serum levels of biomarkers for oxidative stress and inflammation in both sexes. However, consumption of cheese and fermented milk products (e.g., yogurt) was not associated with these effects.
Comment: These authors theorize that d-galactose accounts for the excess risks for death and fracture associated with high milk consumption. This theory is supported by the observation that consuming cheese and fermented milk products — which do not contain d-galactose — was not associated with such negative health effects. Thus, although the authors cannot rule out the possibility of residual confounding and reverse causation, perhaps milk is not a magic bullet.
Citation(s): Michaëlsson K et al. Milk intake and risk of mortality and fractures in women and men: Cohort studies. BMJ 2014 Oct 28; 349:g6015.
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MM: At what point do we look at the potential degree of severity? Statistically we have seen that there is an increased risk of infant suffocation with bumpers, sleeping on a sofa, sleeping in a parents' bed and with bedding. The options for warmth and comfort considered safe are clothing the child during sleep. Yet, for generations small children have had comfort with stuffed animals, small silky ends of receiving blankets and other comforting items that have not traditionally been recognized as risks. A question that seems to have been overlooked is whether specific materials are at a greater danger and if so, are we better off eliminating all "comfort items" or merely those that pose the greatest risks?
Over Half of U.S. Infants Still Sleep in Hazardous Situations
By Jenni Whalen, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
Over half of U.S. infants sleep with blankets, pillows, or other potentially dangerous bedding despite long-standing recommendations against this practice, a Pediatrics study finds.
Between 1993 and 2010, nearly 19,000 caregivers completed a survey about infant sleep practices, including whether bedding was regularly used in the sleep environment. The prevalence of infant bedding use declined but remained high over the study period — from 86% to 55%. Infants most at risk for dangerous sleeping conditions included those born to non-college educated women, teenagers, and women of non-white race/ethnicity.
Commentators remind clinicians: "Discussion of potentially hazardous bedding should be included whenever we talk to parents about the infant's sleep environment and safe sleep practices. Only then will we be able to achieve improvements in these worrisome trends and further reductions in the incidence of SIDS and suffocation deaths."
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MM: The best way to get practitioners to use fewer and unnecessary antibiotics is constant reinforcement. This may be performed in a number of different ways depending on the environment that the practitioner is working in. There is no question that antibiotics are being over- and inappropriately ordered but practitioners must be provided with viable options that will demonstrate consistent patient symptom improvement. This may be the proper use of D-Mannose for urinary tract infections or the use of high dose vitamins C & D for upper respiratory infections. Proper nutritional supplementation for those nutrients that are statistically missing for large numbers of the population such as selenium and zinc would also be good recommendations for much of the population to improve their chances of staying well.
Ann Intern Med 2014 Nov 18; 161:S53
Antibiotic Self-Stewardship Can Cut Treatment Costs
In two units of a Montreal hospital, staff education followed by twice-weekly antibiotic time-out audits reduced annual antibiotic costs by 46%.
Antimicrobial resistance is a serious and increasing problem in treating infections; reducing unnecessary antimicrobial use is believed to be one of the most effective ways to retard the process. The CDC has recommended that clinicians take periodic time-outs to reconsider the type, dose, and duration of antibiotics that hospitalized patients are receiving — so-called “antibiotic self-stewardship.” To investigate the effects of this strategy, researchers compared the use of selected antibiotics and the incidence of nosocomial Clostridium difficile infection before and after the implementation of mandatory time-outs in two 23-bed inpatient units of a Montreal hospital.
Baseline use of carbapenems, moxifloxacin, piperacillin-tazobactam, and vancomycin was established from April 1, 2010, to mid-January 2012. A 30-minute teaching session on self-stewardship was then presented monthly at the start of each clinical staff rotation to all rotating house staff, and senior residents were asked to perform twice-weekly time-out audits for each patient receiving antibiotics.
From mid-January 2012 to early June 2013, 1513 time-out audits were performed on 1062 unique infections involving 679 patients, with auditing conducted on 80% of the assigned days. Although the total monthly use of antibiotics remained unchanged, moxifloxacin and carbapenem use decreased significantly. The units' annual antibiotic cost decreased by 46%, and rates of nosocomial C. difficile infection per 10,000 patient-days fell from 24.2 during the year before the intervention to 19.6 during the year after (incidence rate ratio, 0.8; 95% confidence interval, 0.5–1.3).
Comment: Given the primary purpose of such interventions, the inability to decrease overall antibiotic use is somewhat discouraging. However, the low cost of self-stewardship and the fact that the learned behavior may have long-lasting benefit suggest that extending and modifying this intervention would be worthwhile.
Citation(s): Lee TC et al. Antibiotic self-stewardship: Trainee-led structured antibiotic time-outs to improve antimicrobial use. Ann Intern Med 2014 Nov 18; 161:S53. (http://dx.doi.org/10.7326/M13-3016)

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