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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 23, 2013

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New Breast Implant Approved
EMR Lobbying Pays Off — for Companies
Management Guidelines for Childhood Type 2 Diabetes Mellitus
Treating ADHD Without Drugs: A Meta-Analysis
White House Proposes Brain-Mapping Project
A Magnetic Sphincter Device Shows Promise for GERD
Time Lag to Survival Benefit After Colorectal and Breast Cancer Screening
More Questionable Tests and Procedures Enumerated
CPR: Compression-Only Wins the Long Race
Zinc Deficiency Dermatitis in Premature Infants Tied to Zinc Shortage
Practical Standards of Care for Occupational Contact Dermatitis/Contact Urticaria
Codeine Use for Children-Caution!
Opioids Play a Role in Most Pharmaceutical Overdose Deaths
The Use of Propranolol for Infantile Hemangioma: Consensus Recommendations
Lifting the Taboo on Eggs

MM: This one could fall under the "Who paid off whom" lists of news articles. Can you really imagine that any agency would state, for the record the breast implants "are not lifetime devices"? Would they say the same thing about replacement hips and knees? After all, these all have similar projected wear out durations? C'mon now...
New Breast Implant Approved
By Kristin J. Kelley
The FDA has approved a new silicone gel-filled breast implant (Natrelle 410) for reconstruction in women of any age and for augmentation in women aged 22 and older.
Approval was based on 7 years' worth of data from some 940 women. The most frequently observed adverse outcomes — including asymmetry, capsular contracture, implant removal, and infection — were similar to those seen in other breast implant studies. Another complication, fissures in the gel, is unique to Natrelle 410 implants.
The manufacturer will be required to conduct postapproval studies to assess the long-term safety and efficacy of the product, including five case control studies to look at the possible link between silicone implants and diseases such as brain cancer, cervical/vulvar cancer, and lymphoma. The agency stressed that breast implants "are not lifetime devices."

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MM: I guess its now only Big Pharma that can buy their way into big governmental payouts. I have heard nothing positive from any physician, PA or nurse when it comes to EMR's. Yet, it appears that someone has bought this load of goods. maybe we should just look at these companies as potential sources of enhancing our investment portfolios.
EMR Lobbying Pays Off — for Companies
By Joe Elia
The New York Times details how the largest makers of electronic medical records systems have attempted to influence legislation and support political candidates.
Not all clinicians are happy with the EMR systems — the Times account quotes one emergency department head as rating them as mediocre "on a really good day." However, the companies that make them are thriving. Annual sales at EMR company Allscripts increased more than twofold from 2009 to 2012. One chief executive received over $20 million in total compensation between 2007 and 2011.
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MM: Ok, it's a good thing the pediatricians are finally formally recognizing that young children in western society are plagued by type II diabetes but after looking at these guidelines it appears that the response is nothing more that reactionary rather than preventive. How about increasing physical activity, diminishing carbohydrates, establishing healthier overall lifestyle regimens and losing weight? If we fail to start these practices when are children are young we will simply end up with a very sick and dependant older population that is saddled with chronic health issues and are gross economic burdens to society. This is not the time to look for a quick fix. Actions that last a lifetime are needed!
Pediatrics 2013 Jan 28
Management Guidelines for Childhood Type 2 Diabetes Mellitus
Guidelines for primary care management, including use of insulin, metformin, finger-stick blood glucose and HbA1c monitoring, and lifestyle modification
SPONSORING ORGANIZATION:  The American Academy of Pediatrics (AAP) Subcommittee on Management of T2DM in Children and Adolescents
TARGET POPULATION: Primary care clinicians
KEY POINTS:  The prevalence of type 2 diabetes mellitus (T2DM) in youth is increasing, but the evidence base informing management in this population is not robust. Several professional groups collaborated to review existing evidence (from 1990–2008), including extrapolations from studies of T2DM in adults and T1DM in children, to develop an evidence-based clinical practice guideline for management of newly diagnosed T2DM in 10- to 18-year-olds. The guideline's key action statements for clinicians are:

Pediatric T2DM management should embrace family-centered care. Patient preferences play a "dominant" role in nutrition and physical activity management. When HbA1c and finger-stick blood glucose goals are not met, intensification of therapy is indicated (increased blood glucose monitoring, medication adjustment, stronger focus on lifestyle changes, more frequent primary care visits, and referral to specialists).
Referral to specialists (e.g., endocrinologists, dieticians) is recommended whenever insulin therapy is initiated, treatment goals are not met, or the primary care clinician seeks support from consultants with more expertise. Screening and management tools for comorbid conditions (e.g., hypertension, dyslipidemia, depression, nephropathy) were adapted from other guidelines and included in the accompanying technical report.
Comment: This guideline assists primary care clinicians unfamiliar with the management of this previously uncommon condition in children. Management of pediatric T2DM is rapidly changing with the potential introduction of other oral medication classes (some with serious known side effects in adults) to adolescents with T2DM. Early initiation of metformin, regular HbA1c monitoring, and written "prescriptions" and referrals to help encourage lifestyle modification are key recommendations.
Cornelius W. Van Niel, MD  Published in Journal Watch Pediatrics and Adolescent Medicine February 20, 2013
Citation(s): Copeland KC et al. Management of newly diagnosed type 2 diabetes mellitus (T2DM) in children and adolescents. Pediatrics 2013 Jan 28; [e-pub ahead of print].
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MM: I think that over the years I have had more questions related to "non-pharmacologic" approaches to treating ADD and ADHD than any other condition. I have routinely recommended omega 3 fattty acids. It is reassuring to see more data that supports this approach.
Am J Psychiatry 2013 Jan 30
Treating ADHD Without Drugs: A Meta-Analysis
Supplementation with free fatty acids showed positive effects in analyses of blinded assessments, after adjustment for medication use.
Medication has shown great benefit for symptoms of attention-deficit/hyperactivity disorder (ADHD) among children having this diagnosis, with a high effect size (0.9). Nevertheless, longitudinal outcomes in marital, employment, and legal domains are impaired, even among individuals without histories of conduct disorder (JW Psychiatry Nov 5 2012). In addition, some families prefer nonpharmacological interventions. Studies and meta-analyses of these have had mixed results, partly due to the use of unblinded assessors. To examine the value of such approaches, investigators conducted an industry-supported meta-analysis of all randomized, controlled trials on children with ADHD diagnoses (age range, 3–18).
Studies that combined nonpharmacological and medication interventions were excluded. Of 2904 screened records, 54 studies fit the meta-analysis criteria; one study had both cognitive and neurofeedback arms, yielding 55 analyzed trials.
In analyses of results from both unblinded and blinded assessments, supplementation with free fatty acids (11 studies) and diets excluding artificial food coloring (8 studies) were significantly better than comparison approaches. After adjustment for "treatment as usual" control arms using medication, only free fatty acid supplementation remained significant, with a low effect size (0.17). In analyses of blinded assessments, no other intervention (food elimination, 7 studies; behavioral, 15; neurofeedback, 8; cognitive, 6) showed significance.
Comment: Families adverse to medication can be offered a trial of supplementation with free fatty acids, which has shown positive effects on reading and spelling and thus may be particularly helpful for the 20% to 25% of ADHD children with comorbid learning disabilities. Food-coloring elimination diets, especially for children with known food sensitivities, should be offered only with cautions about the logistic demands and possible negative psychological impact (JW Psychiatry Feb 28 2011). Further studies of dietary add-ons to medication are warranted.
Barbara Geller, MD Published in Journal Watch Psychiatry February 15, 2013
Citation(s): Sonuga-Barke EJS et al. Nonpharmacological interventions for ADHD: Systematic review and meta-analyses of randomized controlled trials of dietary and psychological treatments. Am J Psychiatry 2013 Jan 30; [e-pub ahead of print].
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White House Proposes Brain-Mapping Project
By Kristin J. Kelley
Your patients may be curious about a New York Times story detailing a proposed research project teased by President Obama in last week's State of the Union address to map the human brain. The article topped the most e-mailed, viewed, and blogged lists over the weekend.
The Brain Activity Map project — a collaborative effort between scientists, federal agencies including the NIH, and private foundations — is expected to be part of the president's budget proposal next week. Writing in Neuron last year, scientists said that understanding fundamental brain processes could lead to novel treatments for autism and other disorders.
There is also hope the project would boost the economy similar to the way the Human Genome Project did, says the Times. That initiative, which mapped all genes in human DNA, cost $3.8 billion dollars, but netted some $800 billion, according to federal estimates.
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MM: Although this is a really cool, hi-tech approach it's sort of like using an elephant gun to swat a mosquito. What about chewable digestive enzymes and probiotics? We have seen hundreds of patients overcome their problems of GERD usingour HeartBurn Away chewable product. It contains stevia, probiotics and digestive enzymes. There is no danger of drug interactions, no risk of surgical death and extremely cost effective. Finally, it's readilyy available at Mark Drugs in Roselle and Deerfield.
N Engl J Med 2013 Feb 21; 368:719.
A Magnetic Sphincter Device Shows Promise for GERD
Esophageal acid exposure was significantly reduced in 64% of patients who had the device surgically implanted.
In patients with gastroesophageal reflux disease (GERD) who experience only partial response to proton-pump inhibitor (PPI) agents, antireflux surgery (e.g., fundoplication) is an option to restore functionality to the lower esophageal sphincter (LES). However, 5% to 8% of patients experience new postsurgical symptoms, including dysphagia, gas, and bloating. Now, researchers investigate the safety and efficacy of an alternative surgical treatment for GERD — laparoscopic placement of a magnetic device around the distal esophagus.
As part of a 5-year, industry-funded, prospective study, 100 patients underwent implantation of the device, which provides magnetic force to augment the barrier function of the LES and prevent gastric reflux. Alternately, upon passage of a food bolus, the magnetic force decreases to allow distention of the esophagus (see figure). Study participants had well-established GERD and partial response to PPIs, and surgeons were experienced in performing fundoplication.
Of the 100 participants, 98 completed follow-up at 1 year, 90 at 2 years, and 85 at 3 years. Using intention-to-treat analysis, at 1 year, the primary endpoint of normalization of esophageal acid exposure (pH <4 for ≤4.5% of a 24-hour period) or a reduction of ≥50% in esophageal acid exposure from baseline was achieved in 64% of patients. Quality-of-life scores improved by ≥50% from baseline in 92% of patients, and daily PPI dose decreased by ≥50% from baseline in 93%. No complications occurred during the procedures. Serious adverse events occurred in six patients and required removal of the device in four patients. The most common adverse event was dysphagia (68%), which was observed in 11%, 5%, and 4% of patients during 3 sequential years of follow-up, respectively.
Comment: This technology seems to offer a safe and effective alternative to standard antireflux fundoplication. The procedure was better able to preserve patients' ability to belch and vomit, preventing gas bloat, which is a common problem with fundoplication. In addition, outcomes were similar between academic and community centers, suggesting that the technique can be standardized. This procedure might be of particular value in patients with volume regurgitation, which is not treated as effectively with PPIs as is primary heartburn. For now, however, it is premature to generalize these results beyond this selected study population.
David A. Johnson, MD  Published in Journal Watch Gastroenterology February 20, 2013
Citation(s): Ganz RA et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 2013 Feb 21; 368:719.
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MM: When we look at any test, treatment or procedure we must assess risk vs benefit. That tenet along with , "...first, do no harm..." are, or at least should be the first things to consider before taking any action. With the billions that are spent annually on screening by individuals, Medicare, Medicaid and private insurance plus the damage done by various radiation exposure we must ask is it worth it to do all this? When we look at the cost to Americans compared to other western societies of healthcare and see that ours is more than ten times that of other societies, we should stand back, open our eyes and open our minds and say, "Is something wrong here?" Maybe "routine" screenings should not be so routine. Perhaps these should be reserved for those who are at the greatest risk.
BMJ 2013 Jan 8; 346:e8441
Time Lag to Survival Benefit After Colorectal and Breast Cancer Screening
After about 10 years, 1 colorectal cancer–related and 1 breast cancer–related death were prevented per 1000 people screened.
How long does a person need to live before deriving a survival benefit from breast and colorectal cancer screening? In this meta-analysis of randomized trials in which screened and nonscreened population survival data were reported, investigators estimated the time lag to survival benefit.
They analyzed four colorectal cancer screening trials in which fecal occult blood testing was performed annually or biennially (31,000–150,000 participants; age range, 45–80) and five breast cancer screening trials in which mammography was performed every 12 to 33 months (14,000–61,000 participants; age range, 40–74). For both colorectal cancer and breast cancer, about 10 years were necessary to reach 1 cancer-related death prevented per 1000 people screened.
Comment: In this meta-analysis, more than 10 years elapsed before 1 colorectal cancer–related death and 1 breast cancer–related death were prevented for every 1000 people screened. The authors assert that an absolute risk reduction of 1 per 1000 is "a reasonable threshold where the potential benefit outweighs the potential risks for most patients" because serious harms occur in 3 per 10,000 people who undergo colorectal cancer screening (e.g., bowel perforation during colonoscopy that was prompted by a positive fecal occult blood test) and 1 per 1000 women who undergo breast cancer screening (e.g., unnecessary breast biopsy). Overall, the results suggest that colorectal and breast cancer screening should be reserved for people whose life expectancies exceed 10 years.
Paul S. Mueller, MD, MPH, FACP  Published in Journal Watch General Medicine February 19, 2013
Citation(s): Lee SJ et al. Time lag to benefit after screening for breast and colorectal cancer: Meta-analysis of survival data from the United States, Sweden, United Kingdom, and Denmark. BMJ 2013 Jan 8; 346:e8441.
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More Questionable Tests and Procedures Enumerated
By Joe Elia
The American Board of Internal Medicine Foundation has gathered new recommendations from 17 specialty societies on tests, procedures, and treatments "that physicians and patients should question."
As part of the Choosing Wisely initiative, each society offers five questionables. Among them:

The recommendations are all accompanied by supporting evidence.
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Circulation 2013 Jan 29; 127:435
CPR: Compression-Only Wins the Long Race
Bystanders, forget about the breaths — pump that chest!
While rescue breathing might be important in certain situations, emergency medical service (EMS) dispatchers have a difficult time quickly establishing whether it's appropriate for individual victims. Compression-only cardiopulmonary resuscitation (CPR) obviates the need for this determination, but there have been no definitive long-term data supporting a shift to compression-only CPR.
Researchers combined data from two randomized trials comparing standard CPR with compression-only CPR and measured outcomes up to 5 years after the event. The aggregate group included 2500 patients. Overall survival was 11% at one year, 10.6% at 3 years, and 9.4% at 5 years. Compression-only CPR was associated with a lower risk for death (adjusted hazard ratio, 0.91).
Comment: While the rates of survival after CPR remain dismal, those who are fortunate to remain alive can look forward to a durable benefit. This study supports the 2010 Advanced Cardiac Life Support Guidelines and should encourage EMS dispatchers to instruct lay bystanders to initiate compression-only CPR in adult victims of cardiac arrest.
J. Stephen Bohan, MD, MS, FACP, FACEP  Published in Journal Watch Emergency Medicine February 15, 2013
Citation(s): Dumas F et al. Chest compression alone cardiopulmonary resuscitation is associated with better long-term survival compared with standard cardiopulmonary resuscitation. Circulation 2013 Jan 29; 127:435.
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Zinc Deficiency Dermatitis in Premature Infants Tied to Zinc Shortage
By Christine Sadlowski
Zinc deficiency linked to a shortage of injectable zinc has been tied to severe dermatitis in three extremely premature newborns with cholestasis, researchers report in MMWR. The infants had perioral erosions and bullae on the hands and feet.
Other potential causes such as infections, medication reactions, and parenteral nutrition changes were ruled out, and the lesions improved with enteral zinc supplementation.
Extremely premature infants catabolize zinc rapidly and cannot store it. The authors note that the national shortage of injectable zinc might lead to cases in other neonatal intensive care units. They refer to American Society for Parenteral and Enteral Nutrition recommendations for judicious use of trace elements involved in shortages.
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Br J Dermatol 2013 Feb
Practical Standards of Care for Occupational Contact Dermatitis/Contact Urticaria
Guidelines for occupational contact dermatitis (OCD) and occupational contact urticaria (OCU) are reviewed focusing on practical clinical diagnosis and management.
Occupational contact dermatitis (OCD) accounts for 70% to 90% and occupational contact urticaria (OCU) represents about 10% of occupation-related skin disease. Affected workers have decreased quality of life, they often change occupations, and their skin disease may persist despite complete allergen avoidance. The British Occupational Health Research Foundation offers guidelines on standards of care in clinical practice for these conditions. These recommendations reflect the structure of the British healthcare and work safety systems:

Comment: This review summarizes essential, common sense recommendations for prevention of occupational contact dermatitis and occupational contact urticaria. The importance of primary prevention, access to a physician with appropriate expertise in occupational skin disease, and diagnostic testing should not be minimized. Simple measures such as worker education, workplace hygiene, and good skin care are all necessary to prevent occupational skin disease and rehabilitate affected workers.
— Peter C. Schalock, MD Dr. Schalock is Assistant Professor of Dermatology, Harvard Medical School and Massachusetts General Hospital.
Published in Journal Watch Dermatology February 22, 2013
Citation(s):Adisesh A et al. UK standards of care for occupational contact dermatitis and occupational contact urticaria. Br J Dermatol 2013 Feb 3; [e-pub ahead of print].
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Codeine Use for Children-Caution!
The FDA says that children shouldn't be given codeine to relieve pain after having their tonsils or adenoids removed because the medication can cause death. The FDA will soon require all codeine-containing products to carry a boxed warning to instruct doctors against use in children after such surgeries. The FDA says it has received reports of 13 deaths of children from 1969 to 2012 who had surgery and got codeine-containing drugs afterward; they found that most took place after surgery to remove tonsils and adenoids, and many of the children had sleep apnea.
Editor's Note: Thirteen deaths over 43 years? That's one death every 3.3 years. Does that really justify a "black box" warning? Just wondering!

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Opioids Play a Role in Most Pharmaceutical Overdose Deaths
By Kelly Young
Opioids play a "predominant role" in pharmaceutical overdose deaths, according to a research letter published in JAMA.
Using 2010 national data from death certificates, researchers found that most (58%) drug overdose deaths involved pharmaceutical drugs. The drugs most commonly implicated in overdose deaths were opioids (75%), benzodiazepines (29%), antidepressants (18%), and antiepileptic and antiparkinsonism drugs (8%). In overdose deaths related to other drugs, opioids were often used in combination, which is why the percentages exceed 100.
The authors say these results likely underestimate the problem and conclude: "Tools such as prescription drug monitoring programs and electronic health records can help clinicians to identify risky medication use and inform treatment decisions, especially for opioids and benzodiazepines."
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Pediatrics 2013 Jan; 131:128
The Use of Propranolol for Infantile Hemangioma: Consensus Recommendations
These guidelines will help optimize the safe use of this valuable hemangioma treatment until results of controlled studies become available.
Infantile hemangiomas (IHs) are common benign neoplasms that comprise proliferating endothelial-like cells. As many as 12% require treatment, but the need for FDA-approved therapies remains. In the past, standard treatments such as systemic steroids induced numerous adverse effects and variable responses. Since 1998, the nonselective beta adrenergic receptor blocker propranolol has become the first-line treatment for complicated IH; however, evidence-based recommendations are lacking, and initiation and safety protocols vary. A group of expert clinicians in dermatology, pediatrics, otolaryngology, cardiology, and hematology/oncology gathered to review the existing literature and current practices.
Propranolol therapy has been used safely for 40 years for pediatric arrhythmias, hypertension, congenital heart disease, and hypertrophic cardiomyopathy without a designated pediatric indication. In 2008, it was serendipitously discovered that propranolol therapy shrinks IHs.
Pediatric dermatologists usually recommend pretreatment cardiology evaluation. Infants younger than 8 weeks of gestationally corrected age or with comorbid conditions are typically admitted for monitoring during initiation. Using a 20-mg/5-mL oral solution, the starting dose is 1 mg/kg/day, divided 3 times daily, titrating up to effect to 2 mg/kg/day (less commonly, 3 mg/kg/day). To avoid hypoglycemia, possibly the most common serious complication, the drug should be given with a feeding. Prolonged fasting should be avoided. The peak effect on heart rate and blood pressure occurs 1 to 3 hours after administration, with greatest response occurring after the first dose. Treatment is discontinued during intercurrent illness, especially if poor oral intake or bronchospasm occurs.
Adverse events (hypotension, hypoglycemia, sleep disturbance, and bronchospasm and two reports of hyperkalemia), drug interactions, contraindications, and the risk for stroke in PHACE patients are also reviewed.
Comment: This practical and well-reasoned consensus report is required reading for clinicians who treat infantile hemangioma with propranolol. Despite considerable controversy, these guidelines will help optimize the safe use of this valuable hemangioma treatment until results of controlled studies become available.
Mary Wu Chang, MD  Published in Journal Watch Dermatology February 22, 2013
Citation(s): Drolet BA et al. Initiation and use of propranolol for infantile hemangioma: Report of a consensus conference. Pediatrics 2013 Jan; 131:128.
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BMJ 2013 Jan 7; 346:e8539
Lifting the Taboo on Eggs
Meta-analysis shows little association between egg consumption and coronary heart disease or stroke.
To lower blood cholesterol and cardiovascular disease risk, the American Heart Association (AHA) recommends consuming <300 mg of cholesterol daily (Circulation 2006; 114:82). Because chicken eggs are high in cholesterol (about 200 mg each), clinicians commonly advise patients with elevated blood cholesterol to avoid eating them. However, the association between egg consumption and cardiovascular disease is unclear. In a meta-analysis of 17 prospective cohort studies in which egg consumption was measured with food-frequency questionnaires, investigators assessed this association.
The analysis included nine reports on coronary heart disease (CHD) and eight reports on stroke, with 10 to 20 years of follow-up in most studies. No associations between egg consumption and risk for CHD or stroke were observed. However, subgroup analyses of diabetic patients in which highest and lowest egg consumption were compared showed excess risk for CHD (relative risk, 1.5) and less risk for hemorrhagic stroke (RR, 0.8).
Comment: In this study, egg consumption was not associated with coronary heart disease or stroke except for excess CHD risk in diabetic patients, suggesting that most patients don't need to avoid eggs. The findings are consistent with metabolic research showing that, in most people, dietary saturated and trans fatty acids influence serum LDL cholesterol more than dietary cholesterol does. As the authors note, chicken eggs are inexpensive and rich in protein and other nutrients; moreover, the cholesterol in eggs is easily avoided by not consuming the yolks.
Paul S. Mueller, MD, MPH, FACP  Published in Journal Watch General Medicine February 19, 2013
Citation(s): Rong Y et al. Egg consumption and risk of coronary heart disease and stroke: Dose-response meta-analysis of prospective cohort studies. BMJ 2013 Jan 7; 346:e8539.
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