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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
May 21, 2011

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L-Arginine plus Vitamins Might Reduce Preeclampsia Incidence in High-Risk Women
Is Lower Salt Intake Dangerous?
A Test for Identifying Head Trauma in Athletes
Problems with Vancomycin
Can We Delay Conversion from Mild Cognitive Impairment to Alzheimer Disease?
Angiotensin-Receptor Blockers Aren't Associated with Adverse Cardiovascular Outcomes
White-Coat Effect Accounts for One Third of Resistant Hypertension Cases
Using Viruses to Detect MRSA and MSSA in Blood Cultures
$772 Million Sets Aside by Pfizer for Prempro Drug Case Settlements
Selenium for Graves Orbitopathy?
Memantine Is Not Effective for Mild Alzheimer Disease
Do Antibiotics Increase Risk for Pregnancy in Oral Contraceptive Users?
Curbing the Risk for Stillbirth
Esophageal Adenocarcinoma in Populations with Gastroesophageal Reflux Disease
FDA Updates Risk Evaluation and Mitigation Strategy for Rosiglitazone
Antibiotic Prophylaxis for Dental Procedures
Records Reveal Practices of Accused FDA Insider
Irritable Bowel Linked to Bacteria
Sugar, not Fat, Affirmed as Top Heart-Attacker

L-Arginine plus Vitamins Might Reduce Preeclampsia Incidence
in High-Risk Women

     Supplementation with L-arginine plus antioxidant vitamins might reduce the risk for preeclampsia in women with a personal history of, or first-degree relative with, the condition, according to a BMJ study.
     Some 670 high-risk Mexican women between 14 and 32 weeks' gestation were randomized to consume bars containing L-arginine (the substrate for nitric oxide synthesis) plus antioxidant vitamins, vitamins alone, or placebo. The bars were to be eaten twice daily until the end of pregnancy.
     Preeclampsia or eclampsia occurred less often in the L-arginine-vitamin group than in the placebo group (13% vs. 30%), although an effect was apparent only when treatment began before 24 weeks. Risk did not differ significantly between the vitamin-only and placebo groups.
     Editorialists call the findings important but question their generalizability, as well as the underlying mechanism of action.
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JAMA 2011 May 4; 305:1777
Is Lower Salt Intake Dangerous?
In a controversial study, low-salt diets were associated with elevated cardiovascular disease mortality.
     Salt intake has been correlated directly with blood pressure (BP) in short-term intervention trials. These data inform the premise that decreased salt intake should substantially prevent cardiovascular disease (CVD). Belgian investigators tested this theory among 3681 patients without CVD (26% with hypertension) who were assessed for CVD outcomes in two European prospective cohort studies (median follow-up, 8 years).
     In the overall cohort, a significant but inverse relation was noted between urinary sodium excretion and fatal or nonfatal CVD events. For example, the CVD death rate was 4.1% versus 0.8% in the lowest versus highest tertiles of sodium excretion.
     Two subgroups were created. In the first subgroup, 2096 patients who were normotensive at baseline were followed for incident hypertension; no association was found between urinary sodium excretion and incident hypertension, which was roughly 26%–27% in all tertiles. In the second subgroup, 1499 patients who were not receiving antihypertensive treatment were followed to assess the association of urinary sodium excretion and BP; greater sodium excretion was associated with a significant but small increase in systolic BP.
     Comment: Not unexpectedly, this study has been criticized by many investigators and for many reasons, as reported in the May 3, 2011, New York Times. Two criticisms are that participants were relatively young (mean age, 40) and that the number of CVD events was relatively small. However, the results are not inconsistent with those of other studies. No clinical recommendations can be drawn from the study, but it is certainly provocative and worthy of discussion.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine May 17, 2011
     Citation(s):Stolarz–Skrzypek K et al. Fatal and nonfatal outcomes, incidence of hypertension, and blood pressure changes in relation to urinary sodium excretion. JAMA 2011 May 4; 305:1777. (http://dx.doi.org/10.1001/jama.2011.574)
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Neurology 2011 Apr 26; 76:1456
A Test for Identifying Head Trauma in Athletes
The King-Devick test shows promise as a quick screening tool for head trauma and concussions in boxers and mixed martial arts fighters.
     Although traumatic brain injury (TBI) that is caused by sports-related concussion often improves within a few weeks or months, a substantial number of cases result in chronic brain damage and related chronic disability; some patients experience progressive disease.
     Concussion occurs not just in professional athletes, but also in younger, school-age players of contact sports, in whom the effect of the impact can be even greater (J Athl Train 2009; 44:342). Whatever the athletic venue, rapid screening for early signs of concussion and TBI is needed.
     Toward that end, researchers tested the value of the King-Devick (K-D) test, which measures the speed of rapid number naming and assesses impairment of eye movements, attention, and language. The test, which takes less than 2 minutes to administer, was given to a cohort of 39 boxers and mixed martial arts fighters (mean age, 24) shortly before and after their matches. The more comprehensive, longer Military Acute Concussion Evaluation (MACE) was also administered to these athletes. One of the study authors has a patent pending on the K-D test.
     The speed of performance on the K-D test was significantly slower in athletes who experienced head trauma during the match than in those who did not (mean, 59 vs. 41 seconds; P<0.0001). Pre- to postfight worsening in K-D performance was significantly greater in athletes who experienced head trauma than in those who did not, with the greatest worsening in athletes who experienced loss of consciousness. Greater worsening of K-D scores correlated significantly with postfight MACE scores.
     Comment: The King-Devick test accurately and reliably identified boxers and MMA fighters with head trauma and shows promise as a screening test for concussion. Further studies must determine which athletes are at greatest risk for late neurologic decline after head trauma and concussion. An analysis of APOE*E4 alleles in active and retired high-exposure boxers has shown that genetic predisposition may play a role in the severity of chronic TBI (JAMA 1997; 278:136). This test may be useful in assisting prognostication and the decision to remove an athlete from the field after head trauma.
Jaime Toro, MD Published in Journal Watch Neurology May 17, 2011
     Citation(s):Galetta KM et al. The King-Devick test as a determinant of head trauma and concussion in boxers and MMA fighters. Neurology 2011 Apr 26; 76:1456. http://www.ncbi.nlm.nih.gov/pubmed/21288984?dopt=Abstract
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Clin Infect Dis 2011 Apr 15; 52:975
Problems with Vancomycin
A weak drug is becoming weaker, thanks to more resistant bugs.
     Vancomycin always has been a problematic agent for treating patients with Staphylococcus infections because of its poor tissue penetration and slow bactericidal activity. In recent years, its use has been hampered further by emergence of both tolerant and resistant organisms.
     In a retrospective review from a single U.S. medical center, 320 patients were treated with vancomycin for bacteremic methicillin-resistant Staphylococcus aureus (MRSA) infections between 2005 and 2010; vancomycin failed in 52%, according to standard clinical criteria. Independent predictors of failure included endocarditis, nosocomial infection, serum vancomycin trough levels <15 µg/mL, and a value <421 for the ratio between the area under the drug level curve and the organism minimum inhibitory concentration (MIC). These results validate recent guidelines (JW Infect Dis Jan 12 2011) for vancomycin use suggesting that trough levels be kept higher — at 15 to 20 µg/mL — than previously recommended and area under the curve/MIC ratios be 400 or higher.
     But even unusually high drug doses might not ensure good clinical outcomes. A separate set of investigators performed statistical simulations for various vancomycin dosing regimens and organism MICs, using standard assumptions for nephrotoxicity rates. For relatively resistant organisms (MIC >2.0 µg/mL), even such aggressive dosing regimens as 2 g every 12 hours were estimated to produce a <60% chance of efficacy, along with a >30% chance of toxicity.
     Comment: Vancomycin is still the mainstay of anti-staphylococcal treatment at most U.S. hospitals, but for patients with deep-tissue infections or not-very-susceptible organisms, close collaboration with a clinical pharmacologist is becoming an essential part of treatment, and other anti-staphylococcal drugs actually might be better choices. For some of these patients, the prudent course could be to avoid a long trial of vancomycin and start linezolid, tigecycline, or other MRSA drugs early on.
Abigail Zuger, MD Published in Journal Watch General Medicine May 17, 2011
     Citation(s): Kullar R et al. Impact of vancomycin exposure on outcomes in patients with methicillin-resistant Staphylococcus aureus bacteremia: Support for consensus guidelines suggested targets. Clin Infect Dis 2011 Apr 15; 52:975. (http://dx.doi.org/10.1093/cid/cir124) http://www.ncbi.nlm.nih.gov/pubmed/21460309?dopt=Abstract
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Neurology 2011 Apr 26; 76:1485
Can We Delay Conversion from Mild Cognitive Impairment to Alzheimer Disease?
Control of vascular risk factors may lower the conversion rate.
     Of individuals diagnosed with mild cognitive impairment, 10% to 15% annually go on to develop Alzheimer disease (AD). Vascular risk factors are associated with conversion to AD, but few studies have focused on whether treatment of these influences the conversion rate. Researchers in China examined this question in a 5-year follow-up study of 837 individuals with mild cognitive impairment. Progression was assessed with the Mini-Mental State Examination and the Activities of Daily Living scale.
     By the final year, 298 subjects had converted to AD. Converters were slightly older at baseline than nonconverters (69 vs. 64), less educated, and more likely to be female (63% vs. 54%) or a blue-collar worker (59% vs. 51%) and had higher frequencies of hypertension, diabetes, hypercholesterolemia, cerebrovascular disease, APOE*e4, current smoking, and daily drinking. Participants with hypertension, diabetes, hypercholesterolemia, or cerebrovascular disease (but not current smoking, drinking, or obesity) had faster declines in cognition and function and higher risks for incident AD, compared with individuals without those factors. Specific treatment of hypertension, diabetes, or hypercholesterolemia (but not treatment of smoking and drinking) was associated with lower risk for conversion to AD. Those in whom all vascular risk factors were treated were at lower risk than those who received treatment of only some (hazard ratios, 0.614 and 0.735, respectively).
     Comment: Although no preventive AD treatment exists, vigilant control of modifiable vascular risk factors may benefit those who already are experiencing mild cognitive difficulty. This study emphasizes that we must insure that our patients are receiving proper care to decrease the risk for AD.
Jonathan Silver, MD Published in Journal Watch Psychiatry May 16, 2011
     Citation(s):Li J et al. Vascular risk factors promote conversion from mild cognitive impairment to Alzheimer disease. Neurology 2011 Apr 26; 76:1485
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BMJ 2011 Apr 26; 342:d2234
Angiotensin-Receptor Blockers Aren't Associated with Adverse
Cardiovascular Outcomes

In contrast to results from a 2004 study, a meta-analysis showed no excess risk.
     In 2004, a randomized trial suggested that valsartan (Diovan), an angiotensin-receptor blocker (ARB), was associated with excess risk for myocardial infarction (MI; JW Gen Med Jul 13 2004). In this systematic review and meta-analysis, investigators assessed whether risks for adverse cardiovascular (CV) and other outcomes were associated with use of ARBs.
     The analysis included 37 randomized trials in which placebo or active antihypertensive treatments were compared with ARBs (147,000 patients with average follow-up of 3.3 years). Compared with placebo or active-treatment, ARBs were not associated with excess risk for all-cause death, CV-related death, or angina (relative risks, {approx}1.0 for all outcomes). Furthermore, ARBs were not associated with excess risk for MI (RR, 0.99; 95% confidence interval, 0.92–1.07). In contrast, ARBs were associated with significantly lower risks for stroke (relative reduction, 10%), heart failure (13%), and new-onset diabetes (15%). The results were similar when ARBs were compared with either placebo alone or with active treatment alone.
     Comment: In this large meta-analysis, ARBs were not associated with excess risk for MI, all-cause death, CV-related death, or angina. Furthermore, ARBs lowered risks for stroke, heart failure, and diabetes. These results should reassure clinicians who prescribe ARBs and patients who use ARBs to combat hypertension.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine May 19, 2011
     Citation(s): Bangalore S et al. Angiotensin receptor blockers and risk of myocardial infarction: Meta-analyses and trial sequential analyses of 147 020 patients from randomised trials. BMJ 2011 Apr 26; 342:d2234. (http://dx.doi.org/10.1136/bmj.d2234)
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Hypertension 2011 May; 57:898
White-Coat Effect Accounts for One Third of Resistant Hypertension Cases
Ambulatory blood pressure monitoring reveals the prevalence and characteristics of true versus white-coat resistant hypertension.
     The prevalence of resistant hypertension (RH), defined as persistent elevation in office-measured blood pressure (BP) despite the use of three or more antihypertensive agents (including a diuretic), is not well established. To find out more, investigators used data from the Spanish Ambulatory Blood Pressure Monitoring (ABPM) Registry, funded by the developer of an ABPM platform and network. Of 68,045 patients treated for hypertension, 8295 had RH (51.4% men; mean age, 64.4; mean duration of hypertension, 11.1 years). Of these, half were obese, 13% were smokers, and 32% had type 2 diabetes.
     According to ABPM findings, 62.5% of the RH patients had true RH, and 37.5% had normal values on ABPM and were considered to have white-coat hypertension. Compared with the white-coat group, the true-RH group had higher rates of cigarette smoking, diabetes, left ventricular hypertrophy, microalbuminuria, and previous cardiovascular disease. In addition, the true-RH patients were younger, were more likely to be male, and had a longer duration of hypertension.
     Comment: In this large cohort of patients who underwent ambulatory blood pressure monitoring, about one in eight had resistant hypertension. Of these, one third turned out to have white-coat hypertension. These findings suggest that to ensure a correct diagnosis and to assist in management decisions, ABPM is warranted in all hypertensive patients whose BP is not controlled on three or more drugs.
Joel M. Gore, MD Published in Journal Watch Cardiology May 18, 2011
     Citation(s): de la Sierra A et al. Clinical features of 8295 patients with resistant hypertension classified on the basis of ambulatory blood pressure monitoring.
2011 May; 57:898. http://www.ncbi.nlm.nih.gov/pubmed/21444835?dopt=Abstract
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Rockville, MD: Food and Drug Administration; May 6 , 2011.
Using Viruses to Detect MRSA and MSSA in Blood Cultures
A newly FDA-approved test uses bacteriophages to rapidly identify Staphylococcus aureus — and to distinguish between methicillin-resistant and methicillin-susceptible strains — in blood cultures with gram-positive cocci.
     Culture-based methods for detecting Staphylococcus aureus (SA) in blood and then determining whether the pathogen is methicillin-resistant (MRSA) or methicillin-susceptible (MSSA) can take up to 3 days. More-rapid identification allows for earlier optimization of therapy, which could improve outcomes and reduce unnecessary antimicrobial use. Although several nucleic acid detection tests have been FDA approved for rapid detection of MRSA or SA directly from blood cultures, acceptance has been limited by cost and performance issues.
     The newly FDA-approved KeyPath MRSA/MSSA Blood Culture Test uses bacteriophages that replicate only in the presence of SA to detect and distinguish between MRSA and MSSA in blood cultures with gram-positive cocci in approximately 5 hours. In a manufacturer-sponsored multicenter trial that involved 1116 such samples, the test had a sensitivity of 91.8% and a specificity of 98.3% for SA detection, compared with culture. Among the SA-positive samples, the test was 98.9% and 99.4% accurate for determining MRSA and MSSA, respectively. In a separate study, the test accurately classified as MSSA 28 "empty cassette" SA variants (organisms that cause false-positive MRSA results in some polymerase chain reaction assays).
     Comment: This simple immunoassay requires no special equipment to perform and meets the FDA performance standards for susceptibility tests. Whether the test becomes widely accepted in clinical laboratories will depend on cost and real-world performance. Negative predictive value will vary according to the prevalence of SA bacteremia in each hospital, but the reported sensitivity suggests that up to 8% of SA bacteremias could be missed, limiting the utility of a negative test result.
Daniel J. Diekema, MD, D(ABMM) Published in Journal Watch Infectious Diseases May 18, 2011
     Citation(s): FDA clears first test to quickly diagnose and distinguish MRSA and MSSA [press release]. Rockville, MD: Food and Drug Administration; May 6 , 2011. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm254512.htm)
Bhowmick T et al. Controlled evaluation of a novel method to detect Staphylococcus aureus in blood cultures within 5 hours. 50th Annual ICAAC Meeting, Boston , September 2010. Abstract D-155. (http://viajwat.ch/lfbWFA)
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$772 Million Sets Aside by Pfizer for Prempro Drug Case Settlements
     Pfizer has settled a third of the pending cases over its Prempro menopause drug, It set aside $772 million to resolve claims that the medicine causes breast cancer. The world's largest drugmaker, New York-based Pfizer, said that the reserve provides "the minimum expected costs to resolve all of the other outstanding" lawsuits over its hormone-replacement drugs. The company didn't say how many cases would be settled; however, more than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer.
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N Engl J Med 2011 May 19; 364:1920.
Selenium for Graves Orbitopathy?
A small randomized trial suggests that selenium is safe and effective.
     A small body of research has suggested that selenium and pentoxifylline have roles in treating patients with Graves orbitopathy (also known as ophthalmopathy) through antioxidant and anti-inflammatory mechanisms, respectively. In this multicenter European study, researchers randomized 159 patients with mild Graves orbitopathy to selenium, pentoxifylline, or placebo for 6 months.
     Compared with placebo recipients, selenium-treated patients reported significantly better Graves orbitopathy–related quality of life, and several ophthalmologic endpoints also were judged to be better (according to examinations performed by ophthalmologists blinded to treatment group). Benefits of selenium persisted at 12 months, and no adverse effects were noted. Pentoxifylline was ineffective.
     Comment: Patients with severe orbitopathy generally are treated with corticosteroids. In contrast, mild orbitopathy is often left untreated, even though it can be quite bothersome. This study suggests that selenium supplementation is a safe and effective intervention for patients with mild disease.
Allan S. Brett, MD Published in Journal Watch General Medicine May 19, 2011
     Citation(s): Marcocci C et al. Selenium and the course of mild Graves' orbitopathy.
N Engl J Med 2011 May 19; 364:1920. (http://dx.doi.org/10.1056/NEJMoa1012985)
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Arch Neurol 2011 Apr 11
Memantine Is Not Effective for Mild Alzheimer Disease
Off-label use of memantine for mild AD is not supported by the findings of a meta-analysis that focused specifically on patients with mild disease.
     Memantine is an N-methyl-D-aspartate receptor antagonist that has been approved in the U.S. and Europe as a treatment for moderate-to-severe Alzheimer disease (AD). It is also frequently used off-label for mild AD. To determine whether such use is warranted, researchers conducted a meta-analysis of randomized, double-blind, placebo-controlled, memantine trials that included patients with mild AD. They identified three such trials, each lasting 24 weeks: two U.S. studies of patients with Mini-Mental State Examination (MMSE) scores of 10 to 22 (1 study allowed concurrent use of cholinesterase inhibitors) and a European study of patients with MMSE scores of 11 to 23. Of the 1128 participants in these trials, 431 (38%) had mild AD (MMSE score, 20–23).
     In none of the trials (either individually or combined) did patients specifically with mild AD derive a significant benefit from memantine over placebo in cognitive function, global functioning, activities of daily living, or observed behavior. Given that placebo recipients with mild AD tended to improve on cognitive measures and to remain stable on global measures, drug effects, if any, would have been difficult to discern in trials of this size and duration.
     Comment: This study involved a clever re-examination of data from six memantine trials included in two previous manufacturer-funded meta-analyses that reported positive findings. A meta-analysis from Europe (Alzheimers Dement 2007; 3:7) specifically excluded patients with mild AD, and the other, from the U.S. (Dement Geriatr Cogn Disord 2007; 24:20), collectively analyzed patients at all disease stages. The current, non–industry-supported meta-analysis, which focused specifically on patients with mild AD, documented no advantage of memantine over placebo on any analyzed measures. Off-label use of memantine in patients with mild AD, which is common in clinical practice, is simply not supported by these newly published data.
— Martin Rhys Farlow, MD
     Dr. Farlow is Professor of Neurology, Director of the Alzheimer Clinic, and Vice Chairman for Research, Department of Neurology, Indiana University School of Medicine, Indianapolis. Both he and the lead author are members of the Alzheimer's Disease Cooperative Study Group funded by the National Institute on Aging.
Published in Journal Watch Neurology May 17, 2011
     Citation(s): Schneider LS et al. Lack of evidence for the efficacy of memantine in mild Alzheimer disease. Arch Neurol 2011 Apr 11; [e-pub ahead of print].
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Contraception 2011 May; 83:418
Do Antibiotics Increase Risk for Pregnancy in Oral Contraceptive Users?
Still no credible evidence that antibiotic use increases unintended pregnancy risk in women taking combined oral contraceptives
     Despite a lack of credible evidence supporting the belief that antibiotic use (other than rifampin) is linked to combined oral contraceptive (OC) failure, package inserts for both products warn of potential interactions. Investigators examined this risk using data from two national birth defect surveillance programs involving nearly 44,000 women; 1330 women reported an unplanned pregnancy and OC use for at least 1 month before and part of the month after conception (cases). Cases served as their own controls to derive self-matched odds ratios (ORs) by comparing antibiotic use during the 4 weeks before conception (case period, when antibiotics might be most likely to affect pregnancy risk) with use during the 4 to 8 weeks before conception (control or expected prevalence).
     The prevalence of antibiotic use among women with OC failure was 4.0% during the case period and 3.8% during the control period (OR, 1.08, 95% CI 0.63–1.83). The most commonly used antibiotics were amoxicillin and ampicillin, macrolides, and sulfonamides: 80% were prescribed for 14 days or less. Subanalyses by antibiotic type, allowing a 1 month gap between the case and control periods, or adjusting for occurrence of urinary or upper respiratory tract infections failed to show any significant effect of antibiotic use on unintended pregnancy rates.
     Comment: Other than evidence showing increased risk of unintended pregnancy with rifampin, no convincing scientific data exist to support the notion that concomitant use of antibiotics and combination OCs is associated with OC failure. Given that it is impossible to prove that antibiotic use never causes OC failure, women can certainly use condoms for added security when taking antibiotics. Clinicians should stress proven causes of OC failure: taking pills inconsistently, starting a new pack late, and missing pills (especially during the first or third week). All OC users should also be encouraged to keep emergency contraception on hand.
Alain Joffe, MD, MPH, FAAP Published in Journal Watch Pediatrics and Adolescent Medicine May 18, 2011
     Citation(s):Toh S et al. Antibiotics and contraceptive failure — a case-crossover study. Contraception 2011 May; 83:418.
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Lancet 2011 Apr 16; 377:1331
Curbing the Risk for Stillbirth
Modifiable risk factors for stillbirth in high-income countries include maternal overweight and obesity, advanced age, and smoking.
     The rate of stillbirth in high-income countries has stabilized at 1 per 200 pregnant women who reach 22 weeks' gestation. To examine risk factors for stillbirth in high-income countries, researchers conducted a meta-analysis of studies in which at least one risk factor was assessed and stillbirth was defined as death after ≥20 weeks' gestation or birth weight ≥400 g. Of 22,691 identified studies, 96 from 13 countries (29 from the U.S.) met inclusion criteria (6 prospective and 70 retrospective cohort studies and 20 case-control studies). Most studies excluded women with multiple pregnancies and stillbirths with congenital abnormalities.
     The most critical and potentially modifiable risk factors for stillbirth were maternal weight, smoking, age, preexisting diabetes or hypertension, primiparity, placental abruption, and small-for-gestational-age fetus. The top modifiable risk factor was combined maternal prepregnancy overweight and obesity (body-mass index >25 kg/m2). Odds of stillbirth rose by 23% for overweight, 60% for obesity, 36% for smoking during pregnancy, and 65% for age >35. Heavy smoking (≥10 cigarettes/day) doubled the odds of stillbirth (odds ratio, 1.86) as did maternal age >40 (OR, 2.29). Growth restriction (gestational size <10%) was associated with four times higher risk for stillbirth. Interestingly, gestational diabetes was not associated with excess risk for stillbirth.
     Comment: Most risk factors for stillbirth in high-income countries are modifiable and can be addressed with better educational programs. Strategies to lower incidence of obesity before and after pregnancy could have the greatest effect. Although results of meta-analyses are limited (particularly by the effects of residual confounding), the data identify modifiable risk factors that can be targeted to prevent stillbirth.
Diane J. Angelini, EdD, CNM, FACNM, FAAN, NEA-BC Published in Journal Watch Women's Health May 12, 2011
     Citation(s):Flenady V et al. Major risk factors for stillbirth in high-income countries: A systematic review and meta-analysis. Lancet 2011 Apr 16; 377:1331.
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Esophageal Adenocarcinoma in Populations with Gastroesophageal
Reflux Disease

Incidence of EAC in patients with GERD was very low overall, especially among men younger than 50 and women at any age.
     The incidence of esophageal adenocarcinoma (EAC) has increased rapidly during the past few decades. National society guidelines recommend endoscopic screening for Barrett esophagus in patients with long-standing gastroesophageal reflux disease (GERD). However, the incidence for EAC in demographic subpopulations with GERD is unknown.
     To estimate the age- and gender-specific incidences of EAC among non-Hispanic whites with GERD in the U.S., researchers created a Markov computer model using readily available national surveillance data. To place the results in context, they cited incidences of breast cancer and colorectal cancer (CRC), for which screening recommendations are well established.
     Incidence was lower for women than for men. At any age, women with weekly GERD symptoms had a lower risk for EAC than men without GERD symptoms. For a woman aged 60 with weekly GERD, incidence of EAC was 3.9/100,000 person-years (similar to the incidence of breast cancer in men) compared with 34.6/100,000 for a man with weekly GERD. The incidence of EAC in men younger than 50 with weekly GERD symptoms was relatively low compared with those older than 60. For example, incidence of EAC was 1.0/100,000 person-years at 35 (6.7 times lower than the incidence of CRC) versus 60.8/100,000 at 70 (3 times lower than the incidence of CRC).
     Comment: Although the incidence of EAC has risen sharply, the disease is relatively rare. It occurs primarily in men for unknown reasons. An editorialist notes that neither societal guidelines nor physician practice takes this gender disparity into account when making screening recommendations for EAC, in part to prevent any appearance of sexism. Women with GERD are at the same risk for EAC as men are for breast cancer — a point that might be a useful perspective for clinicians to apply to their practice. Ultimately, analyses from health economics research should provide appropriate guidance.
David A. Johnson, MD Published in Journal Watch Gastroenterology April 22, 2011
     Citation(s): Rubenstein JH et al. Esophageal adenocarcinoma incidence in individuals with gastroesophageal reflux: Synthesis and estimates from population studies.
Am J Gastroenterol 2011 Feb; 106:254
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FDA Updates Risk Evaluation and Mitigation Strategy for Rosiglitazone
     The FDA has updated the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone to include a "restricted access and distribution program."
     Clinicians and patients now must enroll in the Avandia-Rosiglitazone Medicines Access Program to prescribe and receive rosiglitazone. In addition, the drug will not be available at retail pharmacies after mid-November 2011; rather, patients will have to fill their prescriptions by mail order through certified pharmacies.
     Rosiglitazone's use is limited to patients who are currently on the drug and to those whose diabetes is not controlled by other treatments and who do not want to take pioglitazone.
     Rosiglitazone is marketed alone as Avandia, in combination with metformin as Avandamet, and in combination with glimepiride as Avandaryl.
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BMJ 2011 May 3; 342:d2392
Antibiotic Prophylaxis for Dental Procedures
In England, cessation of antibiotic prophylaxis for dental procedures was not associated with a significant increase in the incidence of infective endocarditis.
     The long-standing practice of antibiotic prophylaxis before dental procedures in patients at risk for infective endocarditis (IE) was recently challenged. Consequently, in March 2008, the National Institute for Health and Clinical Excellence (NICE) issued a guideline recommending the cessation of such prophylaxis in the U.K. Now, researchers have quantified the effect of this guideline.
     National monthly prescribing data were examined for all relevant prescriptions issued in England between January 2004 and April 2010. National data on inpatient hospital activity were used to determine the rates of IE and deaths from IE. Rates were compared between two 12-month periods: immediately before guideline implementation and 14–25 months afterward.
     Between the two periods, prescriptions for prophylactic doses of amoxicillin or clindamycin dropped by 78.6%. Before guideline implementation, the rates of IE and IE-related deaths were trending upward. These general upward trends showed no significant increase (defined as >15% over the expected number) after introduction of the guideline. In addition, the upward trend in the number of IE cases caused by oral streptococci (the pathogens for which dental prophylaxis was administered before the 2008 NICE guideline) showed no significant change.
     Comment: One can only be happily amazed at the compliance — primarily by dentists — with the NICE guideline. As the authors point out, these findings do not exclude the possibility that antibiotic prophylaxis might benefit some high-risk patients (e.g., those with prosthetic valves, congenital heart disease, or a history of IE, for whom prophylaxis is still recommended in Europe and the U.S.). Nor can they prove that some cases of IE might have been avoided. However, in the war against antibiotic overuse, these findings offer some rare good news.
Stephen G. Baum, MD Published in Journal Watch Infectious Diseases May 11, 2011
     Citation(s): Thornhill MH et al. Impact of the NICE guideline recommending cessation of antibiotic prophylaxis for prevention of infective endocarditis: Before and after study. BMJ 2011 May 3; 342:d2392
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Records Reveal Practices of Accused FDA Insider
     An FDA employee who is charged with insider trading refinanced his Gaithersburg, Maryland home 10 times within six years and took out $350,000 in credit lines against the property. Property records filed online in Maryland between 1998 and 2004 for former FDA chemist Cheng Yi Liang detail a series of mortgage refinances with eight different banks.
     The SEC (in a complaint filed in late March) said Mr. Liang, 57, used an FDA database to trade in advance of at least 27 FDA announcements involving 19 publicly traded companies, making as much as $3.6 million between 2006 and 2011.
     Mr. Liang used a home-equity line of credit to "funnel money into nominee brokerage accounts to engage in the insider trading scheme," according to related allegations filed the same day by the Department of Justice. Mr. Liang works in the division in charge of approving new drugs, the FDA's most visible and sensitive role.

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May 19, 2011
Irritable Bowel Linked to Bacteria
Separate study finds that gut bacteria affect brain chemistry and may explain some of the anxiety and depression seen in IBS sufferers 
by Craig Weatherby
     The all-too-descriptive term “irritable bowel syndrome” (IBS) is characterized by abdominal pain and cramping, changes in bowel movements, and anxiety/depression disorders. IBS ranks as the most common gastrointestinal complaint in the United States, with about one in six Americans suffering at least some IBS symptoms (see our “IBS basics” sidebar, below). No definitive cause(s) of IBS has emerged to date, but researchers are beginning to uncover some prime suspects … with bacterial infections leading the pack. The infection hypothesis of IBS appears to explain many cases … and new findings lend more weight to that idea. The good news would seem to be that bacterial infection is one IBS-inducer we can attack – and help prevent, in food-service settings – with increasing efficacy as research proceeds.
Infection theory of IBS gets a big boost
     Sometimes, IBS appears after an intestinal infection. And some evidence – breath tests finding bacteria-produced methane, and healing responses to antibiotics – indicates that bacteria play a role in the disease. Last year, researchers from Cedars-Sinai Medical Center in Los Angeles reported that in clinical trials, a targeted antibiotic (rifaximin) provided effective, long-lasting relief of IBS symptoms (CSMC 2010). They said this was the first drug treatment for IBS to relieve symptoms while being administered and for at least 10 weeks after patients stopped the drug. (They weren’t followed longer than that, oddly.) Now, the same team of Cedars-Sinai researchers report two advances in the understanding of Irritable Bowel Syndrome.

One study provides further evidence that IBS is linked to an overgrowth of bacteria in the gut.  And the Cedars-Sinai team’s separate analysis of health data reveals a likely causal link between food poisoning bacteria and many cases of IBS … with military personnel running a much higher risk.

Gut bacteria studies bolsters infection theory
    Along with researchers in Athens, Greece, scientists from California’s Cedars-Sinai looked at small bowel cultures to confirm the presence of small intestinal bacterial overgrowth (SIBO) in patients with IBS. In this study, 320 patients had an endoscopy of their upper GI tract, from which a small bowel culture was cultivated. The participants with IBS were almost four times as likely to show bacterial overgrowth in the small intestine, compared to people free of IBS (37.5 percent versus 10 percent). The overgrowth was more prevalent in those with the diarrhea-predominant version of the disease. Researchers also found more different kinds of bacteria in IBS patients, versus people free of IBS.

     “The better we understand this disease, which affects millions of Americans, the more tools we will have for fighting it,” said Mark Pimentel, MD, director of the Cedars-Sinai GI Motility Program and a primary investigator on both studies (CSMC 2011). “Patients with this condition suffer serious quality of life issues. It's a disease that is frequently misunderstood and difficult for people to talk about, but it's important for the medical community to understand the causes of the disease so we can develop the most effective treatments possible.” (CSMC 2011)

Mathematical analysis links common food-poisoning bugs to IBS
     In a separate study, the Cedars-Sinai team used a mathematical model to analyze data from the Centers for Disease Control and other research studies. The Cedars-Sinai researchers concluded that food poisoning bacteria may account for the majority of irritable bowel syndrome cases. Further, the model predicted higher rates of IBS among military personnel eating in mess halls … as has been seen in other cafeteria-fed “institutional” populations. The model projects that nine percent of people institutional settings, who also have a genetic predisposition for IBS, will contract it after 10 years. 
However, among deployed military and certain other high risk groups, nine percent would develop IBS within a mere six months. As Dr. Pimentel said, “… this study reminds us that we need to pay greater attention to the dietary woes and digestive upsets that long have been the subject of wry discussion among overseas forces”. (CSMC 2011)

     Let’s hope the Defense Department rapidly funds more research, and in the meantime employs tougher sanitation and food service measures to curb infection and IBS rates.}

     Sources: Cedars-Sinai Medical Center (CSMC 2011). Cedars-Sinai Research Deepens Understanding Of Most Common Gastrointestinal Disorder In U.S., Linking It To Bacterial Overgrowth, Food Poisoning. May 11, 2011. Accessed at http://www.eurekalert.org/pub_releases/2011-05/cmc-crd051011.php. Cedars-Sinai Medical Center (CSMC 2010). Cedars-Sinai Research Shows Antibiotic Prevents IBS Symptoms For Weeks After Final Dose: Results confirm earlier Cedars-Sinai studies showing effectiveness of rifaximin against chronic IBS. May 3, 2010. Accessed at http://www.cedars-sinai.edu/About-Us/News/News-Releases-2010/Cedars-Sinai-Research-Shows-Antibiotic-Prevents-IBS-Symptoms-For-Weeks-After-Final-Dose.aspx Kunkel D, Basseri RJ, Makhani MD, Chong K, Chang C, Pimentel M. Methane on Breath Testing Is Associated with Constipation: A Systematic Review and Meta-analysis. Dig Dis Sci. 2011 Feb 1. [Epub ahead of print] Pimentel M, Morales W, Chua K, Barlow G, Weitsman S, Kim G, Amichai MM, Pokkunuri V, Rook E, Mathur R, Marsh Z. Effects of Rifaximin Treatment and Retreatment in Nonconstipated IBS Subjects. Dig Dis Sci. 2011 May 11. [Epub ahead of print] Pimentel M. Evaluating a bacterial hypothesis in IBS using a modification of Koch's postulates: part 1. Am J Gastroenterol. 2010 Apr;105(4):718-21. Shah ED et al. Mathematical Modeling Estimates the Impact of Acute Gastroenteritis On the Development of IBS in the U.S. Digestive Disease Week, May 7-10, 2011, Chicago. Youn YH, Park JS, Jahng JH, Lim HC, Kim JH, Pimentel M, Park H, Lee SI. Relationships Among the Lactulose Breath Test, Intestinal Gas Volume, and Gastrointestinal Symptoms in Patients with Irritable Bowel Syndrome. Dig Dis Sci. 2011 Jan 15. [Epub ahead of print]
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May 19, 2011
Sugar, not Fat, Affirmed as Top Heart-Attacker
NY Times essay clarifies the case against sugar and white flour; Videos and articles summarize flaws in the never-credible “animal fats” theory of cardiovascular disease 
by Craig Weatherby   
     Gary Taubes is the bestselling author of Good Calories, Bad Calories and Why We Get Fat, and he covers the diet-health beat for The New York Times. While we don’t agree with everything he concludes about diets, we think most of what he says about foods and diet is accurate. We do think he performed a public service by penning the recent article, “Is Sugar Toxic?” for the paper’s Sunday magazine.

     Taube begins his piece by noting a YouTube hit few would have predicted: “On May 26, 2009, Dr. Robert Lustig gave a lecture called ‘Sugar: The Bitter Truth,’ [the video of which] … has been viewed well over 800,000 times, gaining new viewers at a rate of about 50,000 per month … “ As he says, these are “… fairly remarkable numbers for a 90-minute discussion of the nuances of fructose biochemistry and human physiology.”

     (There’s also a condensed 11-minute presentation of the sugar story, by nutrition-savvy trainer Sean Croxton, who’s video-interviewed Dr. Lustig, Gary Taubes, and two Vital Choice favorites: whole foods author Nina Plank and the Weston A. Price Foundation’s Sally Fallon.) We encourage you to read Taubes’ essay, which echoes what we’ve been saying, based on the hard evidence: namely, that all sugar – along with corn starch and refined white flour – is bad for your heart and metabolism.

     The facts show that it’s a satisfying but distracting folly to vilify high-fructose corn syrup … and by implication or assertion downplay the (equal) damage done by cane sugar, agave syrup, and other natural sweeteners … refined or not. It’s quite clear that cane sugar and high-fructose corn syrup are equally bad … because both are about half glucose and half fructose. While corn syrup is synthesized (okay, not ideal) and cane sugar is “natural” (but unnaturally refined), this makes exactly zero difference in your body’s reaction to their fundamental components: glucose and fructose.

Cholesterol-fat theory of heart disease: A fiasco from the get-go
     In his seminal 1986 book, Sugar Blues, William Duffy presented a compelling evidence-based case that sugar causes heart disease and diabetes. Duffy relied heavily on the work of John Yudkin, M.D., a British nutrition expert who’d first made the case in his book Sweet and Dangerous, published in 1978. (The most recent besteller on excess sugar's evils was Sugar Shock ... co-authored by Connie Bennet and holistic cardiologist Steven Sinatra, M.D.) Yudkin’s work was dismissed by mainstream medicine, which instead went along with a Congressional panel’s well-meant – but almost entirely erroneous – assertion that dietary cholesterol and saturated fats cause most heart disease. Sadly, that unscientific Congressional report set the agenda for medical research for decades, even as it justified development of hugely profitable cholesterol-lowering drugs.

     This miscarriage of medicine happened even though it soon became clear that most of the “evidence” for this theory consisted of deliberately cherry-picked data … much of it from University of Minnesota nutritionist Ancel Keys’ famed “Seven Countries Study”. To be sure, a small group of genetically unusual people need to drastically limit intake of cholesterol and/or saturated fats and take drugs as needed to manage heart risks.  But these very uncommon exceptions only highlight the compelling evidence that for most people, the cholesterol and saturated fats in animals foods are actively healthful.

      You’ll find links to earlier New York Times reporting on the myths underlying the cholesterol-fat theory of heart disease in our article, “Cholesterol Fiasco Undermines Accepted Theory”. For an excellent history of how cholesterol and saturated fats were named guilty … without credible evidence ... we refer you to a recent essay by Steven Malanga of City Journal, titled “The Washington Diet”. For even more detail on this topic – and the specific, evidence-based clinical implications of various blood cholesterol and fat test results – see the two-part video titled, “I have high cholesterol, and I don’t care” by Chris Kresser, author of The Healthy Skeptic blog. Some of the outrage-inducing history Malanga covers in “The Washington Diet” can be gotten – in a friendlier, funnier way – from the movie "Fat Head" and other videos by former comedian and former health writer Tom Naughton.

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