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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 3, 2011

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Lipitor May Gain New Life for Pfizer
$400 Million May be Paid by Ranbaxy to Settle FDA Issues
Merck to Pay $950 Million to Settle Vioxx Investigation
Further Evidence That Route of Estrogen Administration Affects VTE Risk
Chondroitin Sulfate Holds Promise for Hand Osteoarthritis
FDA Approves Insomnia Drug for Middle-of-the-Night Waking
A Trial of Weight-Loss Strategies in Primary Care
Low Vitamin D Levels Linked to Active Tuberculosis
New Flu Virus Can Spread Among Humans
Global Influenza Dynamics: Even More Complicated Than We Thought
Slow Eating Cuts Calories
Tauzin's $11.6 Million Made Him Highest-Paid Health-Law Lobbyist
Viagra Makers Jailed in China's 'Whac-a-Mole' War on Fakes
HIV Still Not Well Controlled in U.S.
Intermittent Use of Inhaled Glucocorticoids Is as Effective as Daily Use in
   Preschoolers with Recurrent Wheezing
Angiotensin-Converting–Enzyme Inhibitors During Early Pregnancy Aren't
   Significantly Associated with Fetal Malformations
Nifedipine vs. Labetalol for Managing Acute Hypertension of Pregnancy
Not So Mmm Mmm Good? Canned Soup and BPA
Gestational Exposure to BPA Linked with Behavioral Effects
Getting the Red Out: Treating Rosacea with a Topical Vasoconstrictor
Is Pyloric Stenosis a Risk Factor for Chronic Abdominal Pain?
MRSA Colonization in Severely Ill Children Is Associated with Subsequent Infection
Soy-Laden Prison Diets Called Cruel
Cheese Cleared of Cholesterol Charges
Can an Implantable Device Give Early Warning of Congestive Heart Failure?
Brain Benefits of Fish Bolstered by MRI Study
Not All Dietary Fibers Are Equal for Lowering Colorectal Cancer Risk

MM: You have to wonder when a drug company charges big bucks for its brand name product for many years only to reduce the price to mere pennies when its patent runs out. Ethical? Not really. Financially practical? Probably.
Lipitor May Gain New Life for Pfizer
     Pfizer appears to be moving into the retail market place. In an effort to retain sales of Lipitor, Pfizer is planning to sell the drug at generic prices directly to patients. If successful, the risky move could change the pharmaceutical distribution system in the U.S.
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$400 Million May be Paid by Ranbaxy to Settle FDA Issues
     Ranbaxy Laboratories Ltd. may have to pay a penalty of up to $400 million to settle issues with the FDA, which could allow the Indian drug maker to launch its generic version of cholesterol-lowering drug Lipitor in the U.S.
     Ranbaxy is likely to make the drug at its manufacturing facility in New Jersey. Ranbaxy is a unit of Japan's Daiichi Sankyo Co. and is seeking to launch a generic version of Pfizer Inc.'s top-selling Lipitor. However, quality-control and data reporting issues at Ranbaxy have delayed approval from the FDA.

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Merck to Pay $950 Million to Settle Vioxx Investigation
      The U.S. DOJ announced that drug maker Merck will pay $950 million to resolve investigations into its marketing of the painkiller Vioxx. The agency said Merck will pay $321.6 million in criminal fines and $628.4 million as a civil settlement agreement. Part of the deal is that they will plead guilty to a misdemeanor charge that it marketed Vioxx as a treatment for rheumatoid arthritis before getting FDA approval.

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MM: It never ceases to amaze me how we were told for years that oral Premarin® and Estrace® were safe and effective products for women. Well, the word is in. Transdermal delivery systems (creams and patches) are safe and effective forms of receiving estrogen. Compounding pharmacists have been promoting this information for 20+ years. Its nice to know that the rest of the medical and scientific connunity is finally catching up
Menopause 2011 Oct; 18:1052.
Further Evidence That Route of Estrogen Administration Affects VTE Risk
Another retrospective study shows that risk for venous thromboembolism is lower with transdermal estrogen than with oral estrogen.
    Use of oral estrogen by menopausal women raises risk for venous thromboembolism (VTE), and data suggest that risk is lower with transdermal preparations. To address this distinction in a real-world, commercially insured, North American population, investigators conducted a retrospective matched cohort study using health insurance claims data in new users (age, ≥35) of a transdermal estradiol system or oral estrogen therapy. A total of 27,018 transdermal users were matched with an equal number of oral estrogen users; the study was funded by the manufacturer of a transdermal system.
     VTE developed in 115 transdermal estradiol users and in 164 oral estrogen users. Adjusted analysis showed that transdermal estradiol users had significantly lower incidence of VTE than did oral estrogen users (adjusted incidence rate ratio, 0.67); for hospitalization-related VTE, adjusted IRR was 0.38.
     Comment: Yet another retrospective study shows that venous thromboembolism risk is lower with transdermal estrogen than with oral estrogen. Editorialists note that this study is limited in that the authors did not take into account estrogen dose or type of oral estrogen. Whether a prospective study will ever be conducted is doubtful; however, in aggregate, existing data indicate that transdermal estradiol is the preferred route and formulation for women with VTE risk factors (e.g., obesity).
Robert W. Rebar, MD Published in Journal Watch Women's Health December 1, 2011
     Citation(s):Laliberté F et al. Does the route of administration for estrogen hormone therapy impact the risk of venous thromboembolism? Estradiol transdermal system versus oral estrogen-only hormone therapy. Menopause 2011 Oct; 18:1052.
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MM: Over the years I’ve witnessed this debate on what is and is not effective for pain. Pain results are affected by a multitude of factors. Not the least of which is the perception of the person who is experiencing the pain or the relief from it. The bottom line is that when the majority of people who use a product consistently get relief and when they stop using the product the pain returns, then the product is effective. Our All-FlexTM combination contains no Chondroitin but does have a great combination of natural products that consistently work for gout, arthritis and the effects of weekend warrior activities. Call Mark Drugs for more information or visit our website at www.MarkDrugs.com and go to the Synergy Blends section.
Arthritis Rheum 2011 Nov; 63:3383.
Chondroitin Sulfate Holds Promise for Hand Osteoarthritis
The drug conferred moderate symptom relief, compared with placebo.
     In randomized trials, chondroitin sulfate has not been much more effective than placebo for patients with hip or knee osteoarthritis (JW Gen Med Oct 7 2010). Now, Swiss researchers have examined whether chondroitin relieves pain in hand osteoarthritis; they randomized 162 patients with symptomatic and radiographically documented osteoarthritis of multiple hand joints to receive either chondroitin sulfate (800 mg daily) or placebo.
      At 6 months, the mean reduction in pain on a 100-mm visual analog scale (mean baseline score, 54 mm) was 20 mm in the chondroitin group versus 11 mm in the placebo group — a significant difference. Improvement in a hand function score was also significantly greater with chondroitin than with placebo. Grip strength and use of rescue acetaminophen did not differ between groups.
     Comment: Chondroitin and its companion drug glucosamine have had a checkered history — with some successes and some failures — in randomized trials that involved patients with lower extremity osteoarthritis. According to the authors, this study is the first in which the effect of chondroitin on symptoms of hand osteoarthritis was examined. Clinicians can recommend the drug based on this trial, but corroborating studies would be ideal. The preparation used in this study consisted of chondroitins 4 and 6 sulfate of fish origin.
Allan S. Brett, MD Published in Journal Watch General Medicine November 8, 2011
     Citation(s):Gabay C et al. Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: A randomized, double-blind, placebo-controlled clinical trial at a single center. Arthritis Rheum 2011 Nov; 63:3383. (http://dx.doi.org/10.1002/art.30574)
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FDA Approves Insomnia Drug for Middle-of-the-Night Waking
     The FDA has approved the first insomnia treatment for patients who wake up in the middle of the night and then have difficulty falling back to sleep. The zolpidem tartrate sublingual tablets (marketed as Intermezzo) are a lower-dose formulation of the key ingredient in the insomnia drug Ambien.
     Approval was based on two clinical trials, including some 370 patients, in which patients taking the tablets fell back asleep quicker after waking up than those on placebo. The drug previously failed approval twice owing to concerns about its potential impact on driving ability, according to Reuters.
     The tablets should not be taken if alcohol or other sleep aids have been consumed, or if the patient has less than 4 hours of bedtime remaining.
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N Engl J Med 2011 Nov 24; 365:1959
A Trial of Weight-Loss Strategies in Primary Care
And the winners are . . . computer-based coaching, meal-replacement products, and drugs.
     Although primary care providers are urged to help patients lose weight in the name of cardiovascular health, few validated tools are available to allow them to do so. Researchers studied two models of intervention, both designed to be reasonably reproducible in an average outpatient setting.
     In one study, 415 computer-literate obese patients in Baltimore were randomized to receive remote (phone-, e-mail–, and Internet-based) weight-loss coaching (with or without additional individual and group sessions) or usual care (a single coaching session and a list of relevant Internet sites). During 2 years, adherence to the recommended coaching schedules was poor enough that both intervention groups tallied similar median numbers of contacts. Still, both intervention groups lost significantly more weight at 24 months than did the usual-care group: About 40% of participants in each intervention group lost >5% of their baseline weight, in contrast to only 20% of controls.
     In another study, 390 obese patients who were recruited from six Philadelphia primary care practices received monthly sessions with "lifestyle coaches." These coaches were recruited from the staffs of participating practices; none had prior experience in weight management. Half the patients also received a weight-loss "enhancement" intervention, consisting of orlistat (Xenical), sibutramine (Meridia), or free Slim-Fast meal-replacement products. After 24 months, only participants who received enhancement interventions had lost significantly more weight than a usual-care control group; these results remained unchanged when patients who received sibutramine (removed from the market in 2009) were excluded from analysis.
     Although participants in both studies were required to have at least one cardiovascular risk factor, neither group of researchers was able to correlate weight loss with changes in cardiovascular risk factors.
     Comment: An editorialist concludes: "Both these studies provide evidence that PCPs can deliver safe and effective weight-loss interventions in primary care settings." This seems to be a remarkably optimistic interpretation of the data. Given that free Slim-Fast products are not an option, a more skeptical view is that, without pharmaceutical aids, the power of personal coaching from the doctor's office is unimpressive, and the best success comes when patients use computer-based tools to motivate themselves.
Abigail Zuger, MD Published in Journal Watch General Medicine November 22, 2011
     Citation(s): Appel LJ et al. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med 2011 Nov 24; 365:1959. (http://dx.doi.org/10.1056/NEJMoa1108660)
Wadden TA et al. A two-year randomized trial of obesity treatment in primary care practice. N Engl J Med 2011 Nov 24; 365:1969. (http://dx.doi.org/10.1056/NEJMoa1109220)
Yanovski SZ. Obesity treatment in primary care — Are we there yet? N Engl J Med 2011 Nov 24; 365:2030. (http://dx.doi.org/10.1056/NEJMe1111487)
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MM: Recently an article was published regarding Vitamin D-3 and its effect on telomeres, disease and aging. This landmark study gave us the how and why vitamin D-3 may be effective. Now we move on to the clinical experiences. The bottom line is that there is an overwhelming amount of data that demonstrates that we are not getting enough D-3 and that supplementation in conjunction with moderate sun exposure is likely the best option. Once the rest of the medical world realizes that 5,000-10,000IU is an appropriate winter supplement, perhaps our national and international healthcare bills will decrease.
Proc Natl Acad Sci U S A 2011 Nov 22; 108:19013.
Low Vitamin D Levels Linked to Active Tuberculosis
Seasonal declines in mean vitamin D levels were followed by seasonal increases in TB notifications.
     Extended sun exposure was a major component of the pre-antibiotic era treatment of tuberculosis (TB) in sanitariums, based on Nobel Prize–winning work showing that cutaneous TB responds to light therapy. Now, a cross-sectional study in Cape Town, South Africa, once again points to a role for vitamin D in TB.
     Investigators measured vitamin D levels in 370 adults with latent or active TB between April 2005 and January 2010; about half of the participants were HIV positive. Vitamin D deficiency was highly prevalent, with 63% of the study population having serum 25-hydroxyvitamin D levels <50 nmol/L. Patients with active TB had significantly lower mean vitamin D levels than those with latent TB, with the association appearing even stronger for HIV-positive than for HIV-negative individuals. Vitamin D levels varied substantially by season — and TB notifications followed suit. The reporting of new TB cases was lowest in the months that immediately followed seasonal summer peaks in vitamin D levels — and highest in the months that followed seasonal troughs.
     Comment: The authors acknowledge that, given the study design, they cannot exclude the possibility that the observed association is due to active TB lowering vitamin D levels. However, the study results are supported by in vitro work showing that the antimicrobial activity of macrophages is dependent on vitamin D. Clinical trials on the potential of vitamin D to prevent and treat TB seem warranted.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases November 30, 2011
     Citation(s):Martineau AR et al. Reciprocal seasonal variation in vitamin D status and tuberculosis notifications in Cape Town, South Africa.
Proc Natl Acad Sci U S A 2011 Nov 22; 108:19013.
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MMWR Morb Mortal Wkly Rep 2011 Nov 23; 60:1
New Flu Virus Can Spread Among Humans
A recombinant swine-origin influenza A (H3N2) virus was responsible for mild respiratory illness in three children who had contact with each another but had no swine exposure.
     Ever since the first human outbreak of avian influenza in Hong Kong in 1997, public health officials and epidemiologists have worried about the possibility that animal influenza viruses will adapt to allow efficient human-to-human transmission. In 2009, a swine-origin influenza A (H1N1) virus, referred to as pH1N1, did just that, with devastating pandemic results.
     Now, public health authorities in Iowa have reported three cases of a novel swine-origin influenza A (H3N2) infection occurring in children who had no known contact with swine but who did have contact with one another shortly before the first case. All three children tested positive for influenza A on rapid testing and experienced only mild febrile respiratory illness. An additional two cases of influenza-like illness (ILI) occurred in relatives of the three children; neither was tested for influenza, but one was treated with oseltamivir. All five individuals recovered.
     All three respiratory specimens tested by real-time reverse-transcriptase polymerase chain reaction indicated an S-OtrH3N2 virus containing the matrix (M) gene from the 2009 pH1N1 virus. Genetic analysis indicated that this virus would be resistant to the adamantanes but susceptible to neuraminidase inhibitors. Seven other human cases of infection with this virus have been reported this year, but exposure to swine (direct or indirect) preceded all seven.
     Comment: Fortunately, human-to-human spread of this novel reassorted virus appears to have been limited. These cases underscore the ability of influenza A viruses to pick up genes from recently prevalent flu viruses and should prompt vigilance, careful histories of animal exposure, and reporting of ILI outside the usual season.
Stephen G. Baum, MD Published in Journal Watch Infectious Diseases November 30, 2011
      Citation(s):Centers for Disease Control and Prevention (CDC). Limited human-to-human transmission of novel influenza A (H3N2) virus — Iowa, November 2011. MMWR Morb Mortal Wkly Rep 2011 Nov 23; 60:1. (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm60d1123a1.htm?s_cid=mm60d1123a1_w)
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MM: With worldwide flu viruses changing and modifying as rapidly as they do and with the knowledge that the flu vaccine is only about 1% effective, why do government and medical agencies continue to insist on pushing this ineffective product ? Wouldn’t our money and efforts be better spent on strengthing the immune system and improving the quality of our diets? Vitamin D-3 is perhaps the most cost effective and functionally effective product available to enhance immune function. Visit us at www.MarkDrugs.com for more information on this amazing nutritional supplement
Proc Natl Acad Sci U S A 2011 Nov 29; 108:19359
Global Influenza Dynamics: Even More Complicated Than We Thought
The global persistence of influenza A appears to relate to new variants emerging in multiple localities worldwide.
     The emergence of annual winter influenza A outbreaks in temperate climates has been ascribed to the emergence of new strains arising from reservoirs that persist and evolve on a year-round basis in tropical and subtropical regions of East and Southeast Asia. However, a new mathematical modeling analysis does not bear out this hypothesis.
     Researchers analyzed the evolution and migration dynamics of the influenza A H3N2 virus between 2003 and 2006, using 1275 viral sequences from isolates collected in seven geographic regions (Europe, New York State, Japan, Australia, New Zealand, Hong Kong, and Southeast Asia).
     As expected, viruses isolated from the same region in the same year showed high genetic relatedness. In temperate regions, during each influenza season, numerous lineages rapidly emerged from a few initial ones, with the majority of lineages becoming extinct during a single season. In contrast, in Hong Kong and Southeast Asia, lineages persisted for several years, with less genetic diversity and no seasonal fluctuations in the virus populations. Mathematical modeling showed evidence of frequent two-way migration of viruses between temperate regions and tropical Asia, as well as spread of viruses among temperate regions. Each of the tested models supported the concept that outbreaks in temperate regions can be seeded from multiple sources — and that no single geographic location served as a persistent source for annual seasonal influenza epidemics in 2003–2006.
     Comment: This analysis, although subject to the inherent limitations of mathematical modeling, indicates that the persistence and evolution of influenza viruses is more complex than previously thought. Understanding the dynamics of influenza virus evolution is critical to our ability to develop effective seasonal influenza vaccines and devise strategies to prevent or limit future pandemics.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases November 30, 2011
     Citation(s):Bahl J et al. Temporally structured metapopulation dynamics and persistence of influenza A H3N2 virus in humans. Proc Natl Acad Sci U S A 2011 Nov 29; 108:19359.
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MM: This is something that I am guilty of. No matter how often I see thjis information, I have to remind myself to slow down and take my time when I eat. Eating in a group, as a family and with good conversation can slow down our eating and will not only improve our caloric intake and physical health but will enhance our emotional and mental health as well.

November 21, 2011
Slow Eating Cuts Calories
Studies add evidence that slower eating reduces food intake; People concerned about overindulging during the holidays should take note … and can take heart
by Craig Weatherby

     Want a simple way to avoid overeating during the holidays, or anytime? Just slow down! Back in 2007, we reported the results of three studies on how the pace of eating affects food intake … see “Slow Eating May Prevent Weight Gain”. One of those investigations came from researchers at the University of Rhode Island (URI), who recorded volunteers’ eating speeds and calorie intakes (Melanson K et al. 2006).
     The fastest diners – who ate about 3.5 times faster than the slower eaters – consumed more calories. Women who were told to eat quickly consumed 646 calories in nine minutes, but consumed just 579 calories in 29 minutes when encouraged to pause between bites and chew 15 to 20 times before swallowing. Although the results may seem unsurprising, this was the first study to confirm scientifically the common suspicion that eating slowly reduces food intake.
     Now, the same URI team – led by URI associate professor Kathleen Melanson, Ph.D., R.D., – has published the results of a follow-up study. Their findings support prior indications about the relationships between eating rate and body weight … and add more insights.
Men outpace women; Body mass index linked to eating rate
     Among other things, the latest URI studies show that men eat significantly faster than women, heavier people eat faster than slimmer people, and refined grains are consumed faster than whole grains. Melanson’s team found that fast eaters consumed about 3.1 ounces of food per minute, medium-speed eaters consumed 2.5 ounces per minute, and slow eaters consumed 2 ounces per minute. The researchers also found “very strong gender differences” in eating rates. At lunch, the men consumed about 80 calories per minute while the women consumed 52 calories per minute. “The men who reported eating slowly ate at about the same rate as the women who reported eating quickly,” said Melanson (URI 2011).
 The second study, which examined the characteristics associated with eating rates, found a close association between eating rate and body mass index (BMI). On average, people with a high BMI ate considerably faster than those with a low BMI. “One theory we are pursuing is that fast eating may be related to greater energy needs, since men and heavier people have higher energy needs,” said Melanson (URI 2011).
Whole grains slow diners’ eating rates vs. white flour
     In what Melanson called her favorite result, the study also found that the test subjects consumed a meal of whole grains – whole grain cereal and whole wheat toast – significantly slower than when eating a similar meal of refined grains. “Whole grains are more fibrous, so you have to chew them more, which takes more time,” she said (URI 2011). We’d add that fibrous food also produces greater sensations of satiety … which is a major influence on food consumption. While the link between eating rate and obesity is still being studied, Melanson said that her research has demonstrated that eating slowly results in significantly fewer average calories being consumed. “It takes time for your body to process fullness signals,” she concluded, “so slower eating may allow time for fullness to register in the brain before you’ve eaten too much.” (URI 2011).This seems like a great tip for cutting overconsumption at holiday feasts … to stop yourself from overeating, just take your time!
     Sources: Melanson KJ, Greene GW, Petty AJ. 247-P Laboratory and Free-Living Eating Rates in Young Adults Reporting to Be Slow, Medium, or Fast Paced Eaters. Obesity 2011 Abstract supplement; Poster presentations – Sunday, October 2, 2011. Accessed at:
http://www.obesity.org/images/pdf/Obesity2011/Online_Abstracts/2011_poster_abstract_sunday.pdf - - Ponte EE, Melanson KJ, Greene GW. 245-P Characteristics Associated With Eating Rates in Young Adults. Obesity 2011 Abstract supplement; Poster presentations –
Sunday, October 2, 2011. Accessed at:
http://www.obesity.org/images/pdf/Obesity2011/Online_Abstracts/2011_poster_abstract_sunday.pdf.University of Rhode Island (URI). URI researcher provides further evidence that slow eating reduces food intake. October 27, 2011. Accessed at http://www.uri.edu/news/releases/?id=6019
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Tauzin's $11.6 Million Made Him Highest-Paid Health-Law Lobbyist
     Billy Tauzin, former congressman and CEO of the Pharmaceutical Research and Manufacturers of America (PHARMA), was paid $11.6 million in 2010, the year he brokered a deal with President Barack Obama that helped pass the healthcare overhaul.
     Tax records show that after the law was signed, Tauzin left his job as head of PHARMA as the highest-paid lobbyist among groups most involved in the overhaul debate. Karen Ignagni, leader of the insurer lobby, was paid $1.5 million in 2010 while Tom Donahue at the Chamber of Commerce made $4.8 million.
     The disclosure of Tauzin's salary, reported in IRS filings, is renewing questions about the revolving door between government and industry. It feeds the public perception that members are doing big industry's bidding so they can cash out. Some have said that being a member of Congress is just a way-station on the way to a highly paid lobbying job.
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Viagra Makers Jailed in China's 'Whac-a-Mole' War on Fakes
     China jailed eight fake drug makers and raided more than 1,400 drug dens this month as the government stepped up its fight to control an estimated $3 billion of fake drugs in the world's fastest-growing pharmaceuticals market.
China criminalized the manufacture of counterfeit medicines this year and raised maximum penalties to the death sentence to try to contain illegal production in a market that researcher IMS Health estimates will swell 17 percent to $48 billion in the next year. Online sales and a growing health-conscious middle class, coupled with the government's desire to consolidate the industry, is creating "the perfect storm" of fake drugs as some smaller producers turn to unlicensed copies to stay in business. It's like a game of Whac-a-Mole—you knock one problem down and bam, another one pops up!
     China's tougher regulations reflect the dangers of fake medicines compared with other counterfeit issues in the country. "Copying software, T-shirts, or DVDs is an intellectual property issue but it is something entirely different when vulnerable people get sick or die because of counterfeit/fake medicines."
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HIV Still Not Well Controlled in U.S.
     Only about 80% of HIV infections in the U.S. have been diagnosed, according to CDC calculations, and just three quarters of those diagnosed are linked to HIV care.
     But only half of those linked to HIV care stay in care. And so, despite the fact that 90% of those receiving care get antiretroviral therapy, only an estimated 28% of all HIV cases have viral suppression — a rough indicator of infection control.
     The report, which appears online in MMWR, also notes that less than half of patients receiving care get counseling from clinicians on preventing transmission to partners.
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N Engl J Med 2011 Nov 24; 365:1990
Intermittent Use of Inhaled Glucocorticoids Is as Effective as Daily Use in Preschoolers with Recurrent Wheezing
Intermittent use of high-dose budesonide reduced corticosteroid exposure.
     In 2007, the NIH Asthma National Education and Prevention Program Expert Panel recommended long-term daily inhaled glucocorticoid therapy for preschool children with recurrent wheezing. However, concern that daily inhaled glucocorticoids might reduce growth has led to a search for alternative approaches. In a multicenter, randomized, double-blind parallel-group trial, researchers compared the efficacy of daily low-dose inhaled budesonide (0.5 mg nightly when well and when wheezing) or intermittent high-dose budesonide (1 mg twice daily for 7 days at the onset of symptoms or signs of a respiratory tract illness) in 278 children (age range, 12–53 months) who had recurrent wheezing, positive asthma predictive index, and at least one episode requiring oral glucocorticoid therapy, emergency care, or hospitalization.
     After 12 months, no significant differences were noted between groups in frequency of exacerbations requiring oral glucocorticoid rescue, time to first exacerbation of asthma, and frequency of treatment failure. Most exacerbations occurred during respiratory illnesses in both treatment groups. Average budesonide exposure was 104 mg less in the intermittent-regimen group. No significant differences were observed in quality of life measures or for growth of height, weight, or head circumference. Four children in the daily-regimen group and five in the intermittent-regimen group were hospitalized for asthma during the study.
     Comment: Intermittent high-dose inhaled budesonide was as effective as currently recommended daily inhaled glucocorticoids in this carefully selected group of young preschool children with recurrent wheezing. An alternative to daily use that results in less corticosteroid exposure is highly desirable. Guidelines might require revision in the future.
F. Bruder Stapleton, MD Published in Journal Watch Pediatrics and Adolescent Medicine November 23, 2011
     Citation(s):Zeiger RS et al. Daily or intermittent budesonide in preschool children with recurrent wheezing. N Engl J Med 2011 Nov 24; 365:1990.
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BMJ 2011 Oct 18; 343:d5931
Angiotensin-Converting–Enzyme Inhibitors During Early Pregnancy Aren't Significantly Associated with Fetal Malformations
But untreated hypertension was associated with excess risk.
     Although angiotensin-converting–enzyme (ACE) inhibitors are teratogenic when used during late pregnancy, early exposure was not thought to be harmful until a 2006 study showed an association between first-trimester use and excess risk for congenital anomalies. Now, investigators have conducted a population-based cohort study in 465,745 mother–infant pairs from a large health plan in California to determine if first-trimester ACE inhibitor exposure is associated with risk for fetal malformations beyond that associated with use of any antihypertensive medication or with hypertension alone.
     ACE inhibitors were dispensed in 1.6 per 1000 pregnancies, and other antihypertensives were given in 38 per 1000 pregnancies. In adjusted analysis, use of ACE inhibitors or other antihypertensives only during the first trimester only were associated with higher (but not statistically significant) risk for birth defects in liveborn offspring compared with offspring of normotensive women but not compared with offspring of women who had untreated hypertension. In addition, compared with normotensive women, those with untreated hypertension at any time from 1 year before pregnancy through delivery had significantly higher risk for offspring with birth defects (odds ratio, 1.2): specifically, congenital heart disease (OR, 1.4) and neural tube defects (OR, 1.4).
     Comment: As noted by the authors, the comparison groups in this study enabled researchers to "examine and disentangle the pharmacological effect of antihypertensive drugs from the effect of underlying hypertension," which was associated with significantly higher risk for anomalies. However, as is common, only live births were assessed. Because the demographics of women who used ACE inhibitors differed from those of the comparator groups, one group might have chosen pregnancy terminations for anomalies more often than another. Still, these findings indicate that women of reproductive age can remain candidates for this effective class of antihypertensives.
Allison Bryant, MD, MPH Published in Journal Watch Women's Health November 10, 2011
     Citation(s):Li D-K et al. Maternal exposure to angiotensin converting enzyme inhibitors in the first trimester and risk of malformations in offspring: A retrospective cohort study. BMJ 2011 Oct 18; 343:d5931. (http://dx.doi.org/10.1136/bmj.d5931)
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BJOG 2011 Oct 10
Nifedipine vs. Labetalol for Managing Acute Hypertension of Pregnancy
Oral nifedipine and intravenous labetalol were similarly effective.
     Acute control of dangerously high blood pressure (BP) during late pregnancy is critical to good maternal and neonatal outcomes. Investigators in Malaysia conducted a randomized, double-blind trial in 50 pregnant women at ≥24 weeks' gestation with sustained, severe hypertension (defined as ≥160 mm Hg systolic or ≥110 mm Hg diastolic BP measured at least twice within 4 hours) to evaluate efficacy of oral nifedipine (10-mg tablets) versus intravenous labetalol (5 mg/mL). Initial treatments were 10-mg nifedipine plus intravenous placebo or 20-mg labetalol plus oral placebo tablet. Doses were repeated (for nifedipine [maximum cumulative total, 5 tablets]) or escalated (for labetalol [maximum individual dose, 80 mg; maximum cumulative total, 300 mg]) at 15-minute intervals as needed to reach target BPs of ≤150 mm Hg systolic and ≤110 mm Hg diastolic. If target BP was not achieved with 5 dosing cycles, crossover to the other regimen was initiated and continued for as many as 5 cycles; subsequent failure to control BP resulted in open-label treatment of the provider's choice.
     Median time to achieve target BP was 30 minutes for nifedipine and 45 minutes for labetalol, a difference that was not statistically significant. Crossover treatment was required in 20% of participants in each group. Mean maternal heart rate rose substantially during the first hour of treatment in the nifedipine group (from 90 to 104 beats per minute). Overall, BP target levels were achieved in 80% of cases within 5 doses or within 75 minutes following treatment initiation. Fetal heart rate remained consistent during the first hour in both groups.
     Comment: Both oral nifedipine and intravenous labetalol are effective for rapid treatment of severe hypertension in pregnancy. In this study, the starting dose of labetalol was 20 mg, a substantial difference from that in protocols that start at 10 mg. Given that magnesium sulfate is commonly administered to women with preeclampsia, the potential for drug interactions should be considered. Concurrent nifedipine and magnesium sulfate have adverse effects (e.g., severe hypotension, although data are inconsistent), and maternal blood pressure did not drop below 90/60 mm Hg in the present study.
Diane J. Angelini, EdD, CNM, FACNM, FAAN, NEA-BC Published in Journal Watch Women's Health November 10, 2011
     Citation(s): Raheem IA et al. Oral nifedipine versus intravenous labetalol for acute blood pressure control in hypertensive emergencies of pregnancy: A randomised trial. BJOG 2011 Oct 10; [e-pub ahead of print]. (http://dx.doi.org/10.1111/j.1471-0528.2011.03151.x)
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Not So Mmm Mmm Good? Canned Soup and BPA
     Patients may ask about a study suggesting that eating canned soup leads to spikes in urinary excretion of bisphenol A (BPA), a chemical found in the linings of many canned goods. The small randomized crossover trial was reported in a research letter in JAMA.
     Some 75 adults ate 12 ounces of either fresh (made from fresh, not canned ingredients) or canned soup for 5 days, and then crossed over to the other soup for another 5 days. Urine samples, collected on days 4 and 5 of each phase, were positive for BPA in 77% of participants after eating fresh soup and in 100% after eating canned soup. Average urinary BPA concentration was roughly 23 μg/L higher after consuming canned versus fresh soup.
     The authors note that elevated urinary BPA concentrations have previously been linked to cardiovascular disease and diabetes, and conclude that the increase observed here "may be important."
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Pediatrics 2011 Nov; 128:873
Gestational Exposure to BPA Linked with Behavioral Effects
High levels of urinary bisphenol A measured during gestation were associated with anxious and depressed behavior and poorer emotional control in children at age 3 years.
     Bisphenol A (BPA) is used to make polycarbonate plastics and is widely found in food and drink packaging. Virtually everyone in industrialized countries is exposed to BPA. Investigators in Ohio measured urine BPA levels in a prospective birth cohort of 244 mothers and their 3-year-old children. Maternal urine samples were collected at 16 and 26 weeks' gestation and at delivery, and children's urine samples were collected at ages 1, 2, and 3 years.
     Mean gestational BPA concentrations in mothers correlated with childhood behavior and executive function as measured on validated assessment tools at age 3 years. In analysis adjusted for confounders, maternal gestational BPA concentrations were positively associated with scores on measures of anxiety, depression, emotional control, and behavioral inhibition. BPA exposure affected girls more than boys; gestational BPA concentrations that affected behavior in girls were not associated with behavioral effects in boys. Childhood urinary BPA levels were not associated with behavior at age 3 years.
     Comment: In 2007, an NIH panel stated "some concern" about the effects of BPA on fetal and infant brain development and behavior. The results of the current study add to growing concerns about the adverse health effects of dietary and environmental exposure to BPA. The finding that the effects of BPA were gender specific is new, but the analysis lacked statistical power. Although the results are disturbing, the clinical relevance and public health risk are uncertain as is the benefit of reducing exposure. Therefore, it is too soon to make a recommendation to avoid BPA. If the risk is confirmed, BPA will be difficult to avoid, given how ubiquitous this chemical is in our modern environment.
Louis M. Bell, MD Published in Journal Watch Pediatrics and Adolescent Medicine November 23, 2011
     Citation(s):Braun JM et al. Impact of early-life bisphenol A exposure on behavior and executive function in children. Pediatrics 2011 Nov; 128:873
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Br J Dermatol 2011 Nov 2
Getting the Red Out: Treating Rosacea with a Topical Vasoconstrictor
Brimonidine tartrate safely reduced redness in patients with erythematotelangiectatic rosacea.
     Patients tend to hate the redness of facial erythematotelangiectatic rosacea. The highly selective α2-adrenergic receptor agonist brimonidine tartrate (BT) has potent vasoconstricting effects and might be effective as a topical vasoconstrictor. These investigators performed a two-part, phase II, randomized study to determine the efficacy, safety, and optimal dosing of topical BT gel for erythema of rosacea.
     In 122 patients with severe facial rosacea erythema who received a single BT application, BT gel significantly reduced redness in a dose-dependent manner compared with vehicle alone. In a second, more definitive study conducted at 17 sites, 260 patients with moderate-to-severe erythematotelangiectatic rosacea and fewer than three inflammatory papules or pustules applied BT (0.5% or 0.18%) or vehicle daily or twice daily. Significantly better scores on an author-devised and validated scale measuring erythema were achieved with BT 0.5% versus vehicle (P<0.001). The 0.18% cream was also statistically superior to vehicle, but favorable results were less pronounced. Twice-daily dosing did not improve outcomes. No tachyphylaxis, increases in number of lesions, or rebounding occurred in 4 weeks of follow-up. A few patients in the BT and vehicle-alone groups had more erythema at the end of follow-up than at baseline. Recipients generally tolerated the treatments well; one withdrew because of burning sensations. Heart rates and blood pressures remained stable.
     Comment: A safe, effective medical treatment for erythematotelangiectatic rosacea represents an unmet dermatological need. In many previous studies of treatments for papulopustular rosacea, redness scores decreased but seldom sufficiently to satisfy either patients or treating physicians. Happily, in this study, topical brimonidine tartrate safely reduced redness in patients with primarily erythematotelangiectatic rosacea. I previously studied this drug in a proof-of-concept, phase I open study of patients with facial redness of various causes, and also found that topical BT solution rapidly and regularly reduced redness.
Mark V. Dahl, MD Published in Journal Watch Dermatology November 23, 2011
     Citation(s): Fowler J et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment of moderate to severe facial erythema of rosacea: Results of two multicenter, randomized, and vehicle-controlled studies. Br J Dermatol 2011 Nov 2; [e-pub ahead of print]. (http://dx.doi.org/10.1111/j.1365-2133.2011.10716.x)
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J Pediatr 2011 Oct; 159:551
Is Pyloric Stenosis a Risk Factor for Chronic Abdominal Pain?
Infants with pyloric stenosis had a fourfold greater risk for chronic abdominal pain several years later, compared with sibling controls.
     Although the etiology of chronic abdominal pain remains elusive in most cases, some evidence suggests that manipulation or irritation of the gastrointestinal (GI) track in early life might lead to visceral hyperalgesia (an increased sensitivity of sensory neurons in the viscera or in the brain after an injury or inflammation of an internal organ). Visceral hyperalgesia could be the mechanism associated with functional abdominal pain. To determine whether pyloric stenosis and factors involved in its perioperative care are associated with risk for chronic abdominal pain, researchers at a U.S. urban children's hospital compared parent-reported data on GI symptoms for 100 children who underwent surgery for pyloric stenosis in early infancy (mean age at diagnosis, 39 days; mean age at follow-up, 7.5 years) and 91 sibling controls (mean age, 9.2 years). Parents completed the Pediatric GI Symptoms Rome III version questionnaire.
     Chronic abdominal pain (defined as continuous or intermittent abdominal pain for more than 8 weeks) was significantly more common in children with a history of pyloric stenosis than in sibling controls (20% vs. 6%; odds ratio, 4.3). Among the 20 children with a history of pyloric stenosis repair and subsequent chronic abdominal pain, 7 met Rome III criteria for functional GI disorders (irritable bowel syndrome, 3 patients; functional dyspepsia, 2; functional abdominal pain, 2), compared with only 1 patient in the control group (irritable bowel syndrome).
     Comment: Pyloric stenosis and treatment in early infancy was associated with subsequent development of chronic abdominal pain. Prior research suggests that visceral hyperalgesia might be an outcome of stressful events, gastric surgery, perioperative nasogastric tube placement, and suctioning — all of which occur in infants with pyloric stenosis. A prospective study that records GI conditions and symptoms throughout childhood is needed to confirm this association. In the meantime, we might consider gentler ways to handle infants with pyloric stenosis before surgery. Could a reduction in mucosal stimulation from vigorous use of a nasogastric tube decrease visceral hyperalgesia and subsequent functional abdominal pain?
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine
November 23, 2011
     Citation(s): Saps M and Bonilla S. Early life events: Infants with pyloric stenosis have a higher risk of developing chronic abdominal pain in childhood. J Pediatr 2011 Oct; 159:551.
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Clin Infect Dis 2011 Nov 1; 53:853
MRSA Colonization in Severely Ill Children Is Associated with
Subsequent Infection

Nearly 10% of children with MRSA colonization or infection on admission to the intensive care unit developed a later MRSA infection, most often after hospital discharge.
     In adults, colonization with methicillin-resistant Staphylococcus aureus (MRSA) is an independent predictor of subsequent MRSA infection. Recognition of this risk factor has led to implementation of control measures, such as placing colonized patients in isolation with contact precautions. However, such procedures in children may hinder family-centered care and have unintended, lasting consequences. Moreover, the risk for infection among MRSA-colonized children is unknown.
     To explore this issue, investigators reviewed the records of children who were admitted to the pediatric intensive care unit (PICU) at a Baltimore hospital between March 2007 and March 2010 and were screened for colonization with MRSA. Colonization on admission was defined as having an admission nares surveillance culture (or any clinical culture obtained ≤3 days after admission) positive for MRSA.
     Among 3140 children, 153 (4.9%) were found to be colonized or infected with MRSA on admission, including 131 with a positive nares culture and 22 with a positive culture ≤3 days after admission. Thirteen of these 153 children (8.5%) subsequently developed a MRSA infection, compared with 43 of the 2987 (1.4%) who were not colonized or infected at admission (relative risk, 5.9; 95% confidence interval, 3.4–10.1). Of these 56 infections, 46 (82%) occurred after hospital discharge.
     An additional 15 children acquired MRSA colonization in the PICU. Seven such children subsequently developed a MRSA infection — six of them while still hospitalized.
     Comment: In severely ill children (as in adults), MRSA colonization or infection is associated with a considerable risk for subsequent MRSA infection, and this risk seems to be especially high in individuals who become colonized during hospitalization. Unfortunately, the researchers did not examine for methicillin-sensitive S. aureus colonization, which has also been found to be associated with increased risk for infection. As the authors note, future studies should address interventions to prevent nosocomial MRSA transmission to children, as well as measures to protect colonized children from subsequent infection.
Neil M. Ampel, MD Published in Journal Watch Infectious Diseases November 23, 2011
     Citation(s):Milstone AM et al. Methicillin-resistant Staphylococcus aureus colonization and risk of subsequent infection in critically ill children: Importance of preventing nosocomial methicillin-resistant Staphylococcus aureus transmission. Clin Infect Dis 2011 Nov 1; 53:853
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November 21, 2011
Soy-Laden Prison Diets Called Cruel
Price Foundation supports prisoners’ suit over excessive soy protein; evidence doesn't support pro-soy hype
by Craig Weatherby
     Last week, The New York Times reported that Florida prisoners filed a suit challenging the huge amounts of soy in their meals. As the Times wrote, “Eric D. Harris, 34, who is serving a life sentence for sexual battery on a child, said the soy in his prison chow is threatening his health by endangering his thyroid and immune system.” Harris is a notably unsympathetic figure ... but he’s not alone. Many other prisoners say they've suffered from excessive soy protein, and are suing to stop the practice. For example, a U.S. District Court recently ruled that a lawsuit filed by Illinois prisoners claiming to suffer from excessive soy would go forward.
Illinois prisoner’s suit challenges suitability of soy-heavy diets
     As in the Florida case, the Illinois prsioners' lawsuit claims that their soy-laden diet constitutes cruel and unusual punishment in violation of the 8th Amendment to the Constitution, and violates their due process rights under the 14th Amendment. The use of soy in prison meals began when Rod Blagojevich was elected governor of Illinois in 2002. Beginning in January 2003, inmates began receiving a diet largely based on processed soy protein, with very little meat. Early in 2007, the Weston A. Price Foundation (WAPF) began hearing from inmates who were suffering from a myriad of serious health problems due to the large amounts of soy in their diet. (The WAPF is dedicated to spreading word about the benefits of traditional diets from around the world ... see our sidebar, “About the Weston A. Price Foundation”.)
Complaints include chronic and painful constipation alternating with debilitating diarrhea, vomiting after eating, sharp pains in the digestive tract, especially after consuming soy, passing out, heart palpitations, rashes, acne, insomnia, panic attacks, depression, and symptoms of hypothyroidism, such as low body temperature (feeling cold all the time), brain fog, fatigue, weight gain, frequent infections, and thyroid disease. An action alert concerning the Illinois suit can found at “Judge Gives Green Light to Soy Lawsuit”.
Soy instead of seafood: A short-sighted move
     Prison authorities nationwide have introduced soy protein as a cost-cutting substitute for meat, fish, and poultry, with 50 percent of the protein in many meals stemming from soy. Prisoners are not being fed traditional whole soy foods like tempeh (tem-pay) – a fermented whole soybean food – or tofu, which is not cultured or fermented. Instead, the complaints pertain to highly processed soy protein used to make meat and grain substitutes. Nonetheless, some of the nutritional problems cited by critics of foods made with soy protein could also pertain to excessive consumption of tempeh, tofu, or soy milk. Substitution of soy protein for seafood is a penny wise, pound foolish cost-cutting tactic. Studies show that the hostility, aggression, and poor impulse control seen in prisoners and drug abusers – two broadly overlapping groups – improve when they get adequate omega-3s (Gesch CB et al. 2002; Hibbeln JR et al. 2004).
Weston A. Price Foundation’s stance against excessive soy
     Since 2007, the Foundation has been sounding warnings about the problems associated with excessive intake of soy foods. These are outlined on their website’s Soy Alert page, which contains links to supporting scientific references. Their stance became better known when Foundation President Sally Fallon Morell sent an open letter to President-Elect Barack Obama in November of 2008. That letter stated the case against soy-heavy diets:

     The Foundation added more of the disturbing outcomes of excessive soy intake by prisoners, in a press release subsequent to the letter to President-Elect Obama, titled “High Soy Rations Torture Prisoners: Nutrition Expert Asks Obama to Intervene”. Ms. Morrell received no response to her letter, but the WAPF continued its campaign and has been funding a lawsuit on behalf of Illinois prisoners.
     Sources: Alvarez A. Soy Diet Is Cruel and Unusual, Florida Inmate Claims. The New York Times. November 11, 2011. Accessed at http://www.nytimes.com/2011/11/12/us/soy-diet-is-cruel-and-unusual-florida-inmate-claims.html. Balk E, Chung M, Chew P, et al. Effects of Soy on Health Outcomes. Summary, Evidence Report/Technology Assessment: Number 126. AHRQ Publication Number 05-E024-1, August 2005. Agency for Healthcare Research and Quality, Rockville, MD. Accessed at http://www.ahrq.gov/clinic/epcsums/soysum.htm. Liener IE. Implications of antinutritional components in soybean foods. Crit Rev Food Sci Nutr. 1994;34(1):31-67. Review. Hamazaki T, Sawazaki S, Itomura M, Nagao Y, Thienprasert A, Nagasawa T, Watanabe S: Effect of docosahexaenoic acid on hostility. World Rev Nutr Diet 2001, 88:47-52. Hibbeln JR, Ferguson TA, Blasbalg TL. Omega-3 fatty acid deficiencies in neurodevelopment, aggression and autonomic dysregulation: opportunities for intervention. Int Rev Psychiatry. 2006 Apr;18(2):107-18. Review. Buydens-Branchey L, Branchey M, Hibbeln JR. Associations between increases in plasma n-3 polyunsaturated fatty acids following supplementation and decreases in anger and anxiety in substance abusers. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Feb 15;32(2):568-75. Epub 2007 Nov 1. Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. Hibbeln JR, Nieminen LR, Lands WE. Increasing homicide rates and linoleic acid consumption among five Western countries, 1961-2000. Lipids. 2004 Dec;39(12):1207-13. Virkkunen ME, Horroboin DF, Jenkins DK, Manku MS: Plasma phospholipid essential fatty acids and prostaglandins in alcoholic, habitually violent and impulsive offenders. Biol Psychiatry 1987; 22: 1087-1096.
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Cheese Cleared of Cholesterol Charges
Clinical trial found that cheese did not raise cholesterol levels, although butter did; results suggest an advantage to cultured dairy foods 
by Craig Weatherby
     The kinds of saturated fat that predominate in milk products and red meats tend to raise total and LDL cholesterol levels.
This is generally untrue of the saturated fats in plant foods, which have beneficial or neutral effects. Examples include lauric acid and stearic acid, which predominate in cocoa butter and coconut, respectively. It’s become increasingly clear that – excepting the small minority of people with cholesterol-metabolism problems – dietary saturated fats and cholesterol aren’t the real cardiovascular villains. Instead, chronic inflammation – caused or promoted by diets high in sugars, starches, and omega-6 fatty acids from vegetable oils – damages artery walls. The body then uses cholesterol to patch the scarring, resulting in the buildup of plaque that can burst, with dire results. See our sidebar, “The cholesterol myth: distraction born of a deception”.

Danish dairy study absolves cheese of cholesterol crimes
     Cheese and butter have long been seen as cholesterol-raising companions, among doctors and patients alike. But the outcomes of clinical trials published in recent years began to overturn conventional wisdom about the effects of cheese on people’s blood fat profiles (Tholstrup T et al. 2004; Biong AS et al. 2004; Nestel PJ et al. 2005). Now a group of Danish scientists reports that people who ate hard cheese daily had lower LDL (“bad”), HDL (“good”), and total cholesterol levels, compared with people getting the same amount of fat from butter eaten every day. Just as surprisingly, eating a diet that included a substantial amount of hard cheese – providing 13 percent of total daily fat intake – did not raise the volunteers’ LDL levels any more than when the subjects ate their normal diet and no cheese. To the extent that people’s blood cholesterol profiles matter to their risk of heart disease or death – not nearly as much as once believed – the Danes’ findings seem to absolve cheese as a risky food.

     Let’s take a closer look at the results of the Danish cheese-versus-butter trial … which should open more eyes.

Danish study absolves cheese, leaves some butter concerns
      Researchers from the University of Copenhagen recruited 49 men and women. To start, the volunteers ate their regular diet for 14 days, and then were assigned to add cheese or butter to it for six weeks. After a “washout” period of 14 days their regular diets, the volunteers switched diet regimens, with the cheese group changing to butter and vice versa. Each person was assigned to eat an amount of cheese or butter equal to 13 percent of their usual daily intake of calories from fat. Despite eating more saturated fat than their usual diets provided, volunteers eating the added-cheese diet showed no increase in LDL or total cholesterol. In contrast, subjects eating the added-butter diet experienced an average seven percent rise in LDL levels. Importantly, participants’ HDL cholesterol levels did not drop while on the added-cheese diet, compared to the levels measured during the two 14-day usual-diet periods. Surprisingly, compared to the added-butter diet, the volunteers’ HDL levels dropped slightly on the added-cheese diet … but not enough to make a significant difference to heart risk.

Authors couldn’t explain the cheese advantage
     Cheese has a lot of calcium, and increased dietary calcium can boost the amount of fat excreted by the digestive tract. But the amounts of excreted fat detected during the added-cheese diet regimens were not statistically significant. More likely, the differences come down to the larger amount of protein in hard cheeses, and the changes to the composition of the milk wrought by bacterial cultures during the cheese fermentation-aging process.

     The study was funded by two industry groups: the Danish Dairy Board and the U.S. Dairy Research Institute.
     Sources: Biong AS, Müller H, Seljeflot I, Veierød MB, Pedersen JI. A comparison of the effects of cheese and butter on serum lipids, haemostatic variables and homocysteine. Br J Nutr. 2004 Nov;92(5):791-7. Hjerpsted J, Leedo E, Tholstrup T. Cheese intake in large amounts lowers LDL-cholesterol concentrations compared with butter intake of equal fat content. Am J Clin Nutr. 2011 Dec;94(6):1479-84. Epub 2011 Oct 26. Nestel PJ, Chronopulos A, Cehun M. Dairy fat in cheese raises LDL cholesterol less than that in butter in mildly hypercholesterolaemic subjects. Eur J Clin Nutr. 2005 Sep;59(9):1059-63. Tholstrup T, Høy CE, Andersen LN, Christensen RD, Sandström B. Does fat in milk, butter and cheese affect blood lipids and cholesterol differently? J Am Coll Nutr. 2004 Apr;23(2):169-76.
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Circulation 2011 Oct 18; 124:1719
Can an Implantable Device Give Early Warning of Congestive Heart Failure?
An audible alert to patients when intrathoracic impedance crossed a defined threshold not only failed to improve outcomes, it increased the rate of HF hospitalization.
      Identifying patients with heart failure (HF) who are at risk for decompensation and subsequent hospitalization or death remains an important clinical challenge. Results of recent telemonitoring trials have — to the surprise of many — been unimpressive
(JW Cardiol Nov 16 2010).
      Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices often include a feature that measures intrathoracic impedance, potentially providing an early warning system for decompensation by detecting pulmonary fluid retention. In the manufacturer-sponsored, randomized, controlled DOT-HF trial, investigators tested intrathoracic impedance monitoring in 335 patients with systolic HF (mean age, 64; 86% men) enrolled 6 months after implantation of an ICD (18%) or CRT device (82%). "Access" patients received an audible alert if the device detected a prespecified drop in intrathoracic impedance, and their physicians were provided with device-based diagnostic information. The alert was disabled in control patients, who received usual care. Group assignment was not blinded.
     During a median follow-up of 14.5 months, the primary endpoint of all-cause death or HF hospitalization occurred in 29% of access patients and in 20% of control patients, a nonsignificant difference. The number of HF hospitalizations was significantly higher in the access group than in the control group (60 vs. 36; hazard ratio, 1.79), as was the number of outpatient visits (250 vs. 84).
     Comment: The rationale for this study is compelling — a component of implantable device therapy that can identify patients with heart failure who are at risk for adverse clinical events has tremendous appeal. Unfortunately, in this trial, the use of intrathoracic impedance monitoring with patient alerts only increased healthcare utilization. It remains to be seen if other approaches, such as intracardiac pressure monitoring, are any more effective.
Frederick A. Masoudi, MD, MSPH, FACC, FAHA Published in Journal Watch Cardiology November 30, 2011
     Citation(s):van Veldhuisen DJ et al. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation 2011 Oct 18; 124:1719.
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December 1, 2011
Brain Benefits of Fish Bolstered by MRI Study
Novel study links fishy diets to preservation of gray matter in areas shrunken by the Alzheimer’s/dementia process
by Craig Weatherby
“Beware the shrinking brain!” That may sound like a line from a bad horror movie, but brain shrinkage is a very real part of the aging process. Fortunately, the results of an unprecedented study suggest that fatty fish may help people maintain healthy, “full-figured” brains. Losses of brain volume reveal that brain cells themselves are shrinking … a proven sign of current or impending dementia.
Novel study helps explain why fish seems to reduce dementia risk
People who eat fish weekly may be reducing their risk of developing Alzheimer’s disease or milder forms of memory loss. At least, that's the implication of a novel study that compared people's fish intake with their MRI brain scans and tested mental performance (RSNA 2011). Encouragingly, the study's results linked eating baked or broiled fish weekly to maintenance of gray matter in key, dementia-related brain areas over a 10-year period. In contrast, eating fried fish was not linked to protection of gray matter or cognitive capacities. To learn more, see our sidebar, “Fried fish flunks the test”.

This is the first study to detect a link between fish consumption and the health of brain areas shrunken by the Alzheimer’s disease process. As lead author Cyrus Raji, M.D., Ph.D., put it, “… people who consumed baked or broiled fish at least one time per week had better preservation of gray matter volume in brain areas at risk for Alzheimer’s disease.” (UPMC 2011)

Fishy diets may delay dementia and protect thinking, memory
Dr. Raji’s team estimated that their bigger brains make it five times less likely that the fish lovers in the study would develop Alzheimer’s or mild cognitive impairment (MCI) over the next five years. MCI is a mild, early form of dementia, in which memory loss is much less than in full-blown senile dementia or Alzheimer’s. “Consuming baked or broiled fish promotes stronger neurons in the brain’s gray matter by making them larger and healthier,” noted Dr. Raji (UPMC 2011). As he said, “This simple lifestyle choice increases the brain’s resistance to Alzheimer’s disease and lowers risk for the disorder.” (UPMC 2011). The UPMC-led team also tested the volunteers’ cognitive and memory capacities, and those who ate baked or broiled fish weekly scored better versus those who ate fish infrequently. As Dr. Raji explained, “Working memory is destroyed by Alzheimer’s disease. We found higher levels of working memory in people who ate baked or broiled fish on a weekly basis, even when accounting for other factors, such as education, age, gender and physical activity.” (UPMC 2011)

First-ever MRI study detected desirable brain differences in fish lovers
The authors selected 260 cognitively normal people, whose fish consumption was determined by administering the National Cancer Institute’s Food Frequency Questionnaire. Out of all the participants, 163 ate fish on a weekly basis, and the majority of those enjoyed fish one to four times a week. Every volunteer underwent two MRI scans of their brain, 10 years apart. The researchers then compared the brain scans to the volunteers’ reported fish intake – including their favored cooking methods.

They looked for significant links between diet and brain volume in key areas, adjusting the results to account for the differences in brain health status associated with variations in age, gender, education, race, obesity, and physical activity … as well as the presence of the apolipoprotein E4 (ApoE4) gene, which raises the risk of Alzheimer’s. Specifically, eating baked or broiled fish weekly was linked to having greater gray matter volume in the areas of the brain typically shrunken as part of the Alzheimer’s disease process: namely, the hippocampus, precuneus, posterior cingulate, and orbital frontal cortex.

Funding for the study was provided by the National Institute on Aging.

Sources: University of Pittsburgh School of Medicine (UPMC). Eating Fish Reduces Risk of Alzheimer’s Disease, Pitt Study Finds. Nov. 30, 2011. Accessed at http://www.upmc.com/MediaRelations/NewsReleases/2011/Pages/Eating-Fish-Reduces-Risk-Alzheimers.aspx. Radiological Society of North America annual meeting (RSNA 2011). Raji C et al. Regular Fish Consumption Is Associated with Larger Gray Matter Volumes and Reduced Risk for Cognitive Decline in the Cardiovascular Health Study. Neuroradiology (Cognition II); Friday, December 02 2011. Accessed at http://rsna2011.rsna.org/search/event_display.cfm?em_id=11008757. Radiological Society of North America (RSNA). Eating Fish Reduces Risk of Alzheimer's Disease. December 1, 2011. Accessed at http://www.rsna.org/Media/rsna/RSNA11_newsrelease_target.cfm?id=571
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BMJ 2011 Nov 10; 343:d6617
Not All Dietary Fibers Are Equal for Lowering Colorectal Cancer Risk
Whole grain and cereal fibers were linked with lower risk; fruits, vegetables, and legumes
were not.

     The association between dietary fiber intake and colorectal cancer risk is unclear. In a meta-analysis of 25 prospective observational studies that involved nearly 2 million people, investigators assessed this association.
     Participants' daily fiber intake ranged from 6 to 21 g for total fiber, 2 to 16 g for fruit fiber, 2 to 17 g for vegetable fiber, 3 to 17 g for cereal fiber, and 1 to 4 g for legume fiber. Daily whole grain intake ranged from 61 g to 128 g. Participants with high total fiber intake had 12% lower risk for colorectal cancer than those with low total fiber intake. When intake was analyzed by fiber type, people with high cereal fiber intake had 10% lower risk, and those with high whole grain intake had 21% lower risk, than people with low intakes of these fibers. Dose–response relations were observed for each of these fiber types. In contrast, intake of fiber from fruits, vegetables, or legumes did not affect colorectal cancer risk.
     Comment: In this meta-analysis, intakes of total dietary fiber, cereals, and whole grains were associated inversely with colorectal cancer risk; dose–response relations were observed. These results are biologically plausible: Dietary fiber increases stool bulk, dilutes fecal carcinogens, and shortens stool transit time (thereby lowering colorectal mucosa exposure to carcinogens). Although an earlier randomized trial showed conflicting results (JW Gen Med Feb 17 2006), participants in that trial who were randomized to increase their daily fiber intake raised it only marginally (from 15 to 18 g).
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine
December 1, 2011
     Citation(s):Aune D et al. Dietary fibre, whole grains, and risk of colorectal cancer: Systematic review and dose-response meta-analysis of prospective studies. BMJ 2011 Nov 10; 343:d6617. (http://dx.doi.org/10.1136/bmj.d6617)
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