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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
May 12, 2012

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Forecast: 42% of Americans Will Be Obese in 20 Years
Eating Certain Fish Might Prevent Liver Cancer
Testosterone Hormone Replacement Therapy May Help Male Weight Loss
FDA Panels Recommend Approval of New Drugs for Weight Loss, HIV Prevention
FDA Warns Against Experimental MS Treatment
Meta-Analysis: Probiotics Associated with Lower Risk for Antibiotic-Related Diarrhea
FDA Questions Whether Long-Term Use of Bisphosphonates Provides Fracture Benefit
Institute of Medicine Issues Hefty Report on Obesity Prevention
Treatment of Subclinical Hypothyroidism Is Associated with Fewer Ischemic Cardiac Events
Why Sleep Patterns Matter
"Pink Slime" Crusade Forces Beef Plant Closures
17 Studies Say Zinc May Shorten Common Colds in Adults
Avian Influenza Transmission in Mammals
Inappropriate Use of Antibiotics in Livestock Is Common)
Epidural Steroids, Etanercept, or Saline Injections for Subacute Sciatica?
Bottle-Feeding Linked to Greater Infant Weight Gain, Regardless of Milk Type

Forecast: 42% of Americans Will Be Obese in 20 Years
By 2030, 42% of Americans will be obese, according to new estimates from the CDC. Currently, roughly 35% of adults fall into this category. In 20 years, 11% will be severely obese (100 pounds or more overweight), about double the current rate.
Researchers point out that earlier estimates forecast obesity rates above 50% and that the new estimates show a "leveling off," which, as one warned, still represents a serious problem.
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Gastroenterology 2012 Feb 16
Eating Certain Fish Might Prevent Liver Cancer
In a large prospective study in Japan, higher consumption of fish with n-3 polyunsaturated fatty acids translated to lower risk for hepatocellular carcinoma.
Dietary n-3 polyunsaturated fatty acids (PUFAs) have been demonstrated to protect against several cancers. However, their protective benefit against hepatocellular carcinoma (HCC) has been inconsistent in the mostly retrospective studies conducted.
To investigate the association between fish and n-3 PUFA consumption and HCC, researchers analyzed data from a large-scale, population-based, prospective cohort study involving 90,296 people in Japan (aged 45–74). A validated food intake questionnaire — including items on fish rich in n-3 PUFAs (salmon or trout, sea bream, horse mackerel or sardine, mackerel pike or mackerel, and eel) — was completed at baseline by 84% of the cohort. Only 0.4% of subjects were lost to follow-up. During an average follow-up of 11.2 years (1,008,595 person-years), 398 cases of HCC were newly diagnosed.
Total fish consumption was not significantly associated with lower risk for HCC. However, in multivariate analysis, consumption of n-3 PUFA-rich fish showed a dose-dependent, inverse association with risk for HCC (hazard ratio, 0.64; P for trend=0.04). Similar dose-dependent, inverse associations with HCC were demonstrated for consumption of the individual n-3 PUFAs eicosapentaenoic acid (EPA) (HR, 0.56; P for trend=0.01), docosapentaenoic acid (HR, 0.64; P for trend=0.05), and docosahexaenoic acid (DHA) (HR, 0.56; P for trend=0.03). These associations remained in a subgroup analysis of 17,500 participants with data on hepatitis C and B viruses.
Comment: In this large, population-based cohort study, consumption of fish rich in n-3 polyunsaturated fatty acids reduced the risk for hepatocellular carcinoma, perhaps through anti-inflammatory effects or improvement in insulin sensitivity. These results should be confirmed in other settings and with more robust dietary information (not just that collected at baseline,) but it is reasonable to advocate a diet rich in n-3 PUFA — especially for patients with cirrhosis who are at high risk for HCC.
Atif Zaman, MD, MPH Published in Journal Watch Gastroenterology May 11, 2012
Citation(s): Sawada N et al. Consumption of n-3 fatty acids and fish reduces risk of hepatocellular carcinoma. Gastroenterology 2012 Feb 16; [e-pub ahead of print].
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Testosterone Hormone Replacement Therapy May Help Male Weight Loss
Older obese men could shift excess weight by taking testosterone supplements, suggest findings announced at the European Congress on Obesity. A study reported that hormone-deficient men who were given testosterone supplements in a similar way to hormone replacement therapy for older women lost an average of 16 kg over five years when testosterone levels were increased back to normal. Experts warn that supplements may not be the answer because of the possibility of prostate cancer and heart disease. The study also suggested that increasing testosterone levels could reduce waist circumference and blood pressure.
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FDA Panels Recommend Approval of New Drugs for Weight Loss, HIV Prevention
FDA advisory panels recommended approving a new weight loss drug and the first drug for HIV prevention, the Associated Press reported Thursday.
The anti-obesity drug lorcaserin did not receive approval in 2010, when the agency cited an increased risk for tumors in animal studies. The manufacturer has since provided data showing only a "negligible" risk. But the drug may pose increased risks for hypertension in patients with diabetes, as well as for valvular heart disease.
A separate advisory group recommended approval of the first drug to prevent HIV infection, also known as pre-exposure prophylaxis (PrEP). Truvada, a combination of tenofovir plus emtricitabine (TDF/FTC), is already approved to treat HIV infection.
In his blog HIV and ID Observations, Dr. Paul Sax writes, "the use of TDF/FTC for PrEP has been quite limited, for a whole lot of reasons — including ... [its] cost, and concerns about long-term toxicity."
The FDA is expected to make final decisions on both drugs in June.

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FDA Warns Against Experimental MS Treatment
The FDA warned clinicians on Thursday that "liberation therapy," an experimental procedure that uses angioplasty balloons or stents to open narrowed veins in the chest and neck, has not been approved to treat chronic cerebrospinal venous insufficiency (CCSVI) and could be dangerous.
Liberation therapy has been associated with one death due to a brain hemorrhage and one stroke, says the FDA. Other possible risks include blood clots, cranial nerve damage, and migrating stents.
Proponents of the treatment suggest that CCSVI is linked to symptoms of multiple sclerosis, but according to the agency, studies on the link have not been definitive. In addition, there is no consensus on diagnostic criteria for CCSVI nor is there evidence that the therapy effectively treats MS.
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Meta-Analysis: Probiotics Associated with Lower Risk for Antibiotic-Related Diarrhea
Probiotics seem to lower the risk for antibiotic-associated diarrhea (AAD), a JAMA meta-analysis finds, but the available research doesn't support conclusions about which preparations work best or which patients benefit most.
Researchers examined over 80 randomized trials in which probiotics were used to either prevent or treat AAD. In a subset of 63 trials including some 12,000 participants, they found a lower pooled risk for AAD among those receiving probiotics (0.58), compared with controls. They estimate the number needed to treat at 13 to prevent one case of AAD.
However, the authors found poor documentation of the probiotic strains used, unexplained heterogeneity among the trials, and little reporting on adverse effects of treatment.
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FDA Questions Whether Long-Term Use of Bisphosphonates Provides Fracture Benefit
An FDA analysis, published in the New England Journal of Medicine, calls into question the fracture-prevention benefits of long-term bisphosphonate use.
The FDA examined three randomized trials in which bisphosphonates were given initially for at least 3 years, and then extended for an additional 3 to 6 years (total duration, 6–10 years). Pooled data showed that women receiving bisphosphonates for at least 6 years had similar overall fracture rates as those who switched to placebo (roughly 10% and 8.5%, respectively).
The authors say there are not enough data to determine which subgroups of patients may benefit from use beyond 3 to 5 years. But commentators provide the following recommendations:

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Institute of Medicine Issues Hefty Report on Obesity Prevention
A 500-page report, "Accelerating Progress in Obesity Prevention," has been issued by the Institute of Medicine. The report, available free online, makes a series of recommendations. Among them, clinicians should:

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Arch Intern Med 2012 Apr 23
Treatment of Subclinical Hypothyroidism Is Associated with Fewer Ischemic Cardiac Events
But only in patients younger than 70
Subclinical hypothyroidism (serum thyrotropin level, 5.01–10.0 mIU/L, and normal free thyroxine level) has been associated with elevated risk for adverse cardiac events and mortality in middle-aged, but not older, adults. Randomized trials of treating patients with subclinical hypothyroidism have been small and short term, and they have focused on subjective symptoms, not cardiac endpoints. Whether to treat patients with subclinical hypothyroidism has been controversial.
In this retrospective cohort study, U.K. researchers identified 3093 younger patients (age range, 40–70) and 1642 older patients (age, >70) with subclinical hypothyroidism; roughly 50% in each group were treated with levothyroxine (median dose, 75 µg daily). In analyses adjusted for baseline cardiovascular risk, the number of ischemic heart disease events in younger patients was 39% lower in those who were treated than in those who were not treated, during median follow-up of 7.6 years. No difference was found between treated and untreated older patients.
Comment: This retrospective study of patients with subclinical hypothyroidism cannot account for the many possible reasons that some patients were treated and others were not. Thus, no treatment recommendation can be made based on these results. The authors believe that a randomized controlled trial, focused on cardiac outcomes, is justified; however, a study that is adequately powered to show whether treatment improves cardiovascular outcomes or mortality would be very large and long term.
Thomas L. Schwenk, MD  Published in Journal Watch General Medicine May 8, 2012
Citation(s): Razvi S et al. Levothyroxine treatment of subclinical hypothyroidism, fatal and nonfatal cardiovascular events, and mortality. Arch Intern Med 2012 Apr 23; [e-pub ahead of print].
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Sci Transl Med 2012 April 11; 4:129ra43
Why Sleep Patterns Matter
Prolonged experimental shortening or disruption of sleep led to a prediabetic condition.
Epidemiologic studies suggest that people who habitually sleep fewer than 6 hours nightly, or whose sleep patterns do not correspond to normal circadian rhythms, have excess risk for developing obesity and type 2 diabetes. Researchers conducted a controlled study to confirm and explain this observation. Twenty-one participants lived in individual quarters in a sleep laboratory for 6 weeks. They had no contact with the outside world (including cues about nighttime and daytime); timing of meals, caloric intake, and activity levels were experimentally controlled. For the first 3 weeks, 10 hours of darkness ("sleep opportunity") occurred during what was nighttime in the outside world. For the next 3 weeks, the amount and timing of darkness was experimentally manipulated to be shorter (providing the equivalent of a 5.6-hour sleep opportunity per 24 hours, the rest of which consisted of monitored wakefulness) and to start 4 hours later each night, until "nighttime" was beginning during what was actually daytime. A 9-day recovery period consisted of 10 hours of nightly sleep that always occurred at true nighttime.
Insulin sensitivity, pancreatic insulin secretion, and resting metabolic rates all dropped during sleep disruption, which raised blood glucose levels. These physiological changes reverted to or toward baseline during the recovery period.
Comment: This experimental study provides strong evidence to support the epidemiologic observations that sleep that is regularly short or out of phase with day–night cycles (situations typical of shift work) can cause physiological changes that predispose people to type 2 diabetes.
Anthony L. Komaroff, MD Published in Journal Watch General Medicine May 8, 2012
Citation(s): Buxton OM et al. Adverse metabolic consequences in humans of prolonged sleep restriction combined with circadian disruption. Sci Transl Med 2012 April 11; 4:129ra43. (http://dx.doi.org/10.1126/scitranslmed.3003200)
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"Pink Slime" Crusade Forces Beef Plant Closures
Beef Products Inc will close plants on May 25 in Amarillo, Texas; Garden City, Kansas; and Waterloo, Iowa. About 650 people will lose their jobs when the plants close. This is a direct result of all the misinformation about our lean beef. Iowa Governor Terry Branstad on Monday called the closings a "sad day for the state of Iowa." "The fact that a false, misleading smear campaign can destroy a company's reputation overnight should disturb us all," Branstad said in a statement. The beef product was considered safe by the FDA.
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17 Studies Say Zinc May Shorten Common Colds in Adults
Data was analyzed from 17 studies, involving 2,121 people who had been randomly assigned to take zinc or a placebo within three days of coming down with a cold. Medication was taken either as a lozenge, as a tablet or in syrup form. On average, cold symptoms disappeared about three days sooner among adults who took zinc than they did for those taking the placebo, especially when higher doses of zinc were taken.
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Nature 2012 May 2
Avian Influenza Transmission in Mammals
The first of two highly controversial studies of modified avian H5N1 influenza virus has now been published.
Concern remains that the avian H5N1 influenza A virus that has caused widespread infection of birds in Asia, Africa, and Europe could evolve and cause a pandemic in humans. Given reports of high mortality in the few reported cases of human H5N1 disease, last fall's news that two research groups had created genetically modified avian H5N1 strains that could be efficiently transmitted between ferrets triggered intense international debate as to whether the research should have been allowed or the results should be published. The U.S. National Science Advisory Board for Biosecurity recently decided to allow publication, and one of the studies has now been released.
Noting that the influenza hemagglutinin (HA) protein plays a key role in the transmissibility of influenza in mammals, Imai and colleagues introduced random mutations into the HA protein of an H5N1 strain, then screened a library of these mutated viruses for the ability to bind to human-type sialic-acid receptors. They isolated nine viruses with human-type receptor-binding capability; two such viruses exhibited strong binding to ciliated epithelial cells of the human trachea. The researchers then used reverse genetics to combine the modified HA genes from these two viruses with the remaining genes from a 2009 H1N1 human pandemic virus to create novel hybrid viruses that could be tested in ferrets. With multiple passages in these animals, additional mutations arose in the hybrid viruses. One such virus was efficiently transmitted between ferrets by respiratory droplets; four amino-acid substitutions in H5 HA contributed to this capacity. The hybrid viruses caused weight loss and lung lesions but were not highly pathogenic and did not cause death.
Comment: That the hybrid viruses created in this work were relatively nonpathogenic is somewhat reassuring. Indeed, work published this spring suggests that many humans may have had relatively mild H5N1 disease (JW Infect Dis Mar 7 2012). Still, an H5N1 pandemic would have major public health implications. The present findings should allow better surveillance for H5N1 viruses with pandemic potential and should thus promote timely generation of appropriate vaccines and initiation of other infection-control measures.
Richard T. Ellison III, MD Published in Journal Watch Infectious Diseases May 9, 2012
Citation(s):Imai M et al. Experimental adaption of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 2012 May 2; [e-pub ahead of print].
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J Antimicrob Chemother 2012 Apr; 67:1027
Inappropriate Use of Antibiotics in Livestock Is Common
Antibiotics were given to calves mostly as group treatments and were frequently under- or overdosed.
A sizeable proportion of the antibiotics produced worldwide is administered to livestock, either to prevent local epidemics or to treat illness. Despite increasing attention to antimicrobial resistance in farm animals and transmission of resistant pathogens from these animals to humans (JW Infect Dis May 2 2012), indications for and administration of antimicrobials in veterinary medicine have rarely been examined.
Researchers in Belgium recently published a prospective investigation of antibiotic use in veal calves from birth to slaughter (total, 5853 animals in 15 herds, studied for a mean of 196 days). Five of these herds (2334 animals) were included only in the group-treatment analyses because of unreliable individual treatment records. Overall, the calves received antibiotics during 38% of their lives, with the largest amounts during the first 10 weeks.
Group treatments, administered orally in milk, accounted for 96% of all treatment events and 98% of total antibiotic use. The most common indications for group treatment were respiratory disease (53%), gastrointestinal infections (diarrhea and nonspecific bacterial enteritis; 24%), and "arrival prophylaxis" (13%). A combination of two antimicrobials was used in 33% of such treatments. The agents most frequently administered were oxytetracycline (24%), amoxicillin (19%), tylosin (17%), and colistin (15%). Comparison of actual doses with doses correctly calculated by body weight revealed that 44% of the treatments were underdosed and 37% were overdosed.
Individual antimicrobial treatment was usually given by injection. Overall, 82% of the individually used antimicrobial formulations were overdosed and 5% were underdosed. In 4 of the 10 monitored cohorts, none of the individual treatments was administered by a veterinarian.
Comment: Mass administration of antibiotics, incorrect dosing of most treatments, poor documentation, infrequent involvement of veterinarians — Do these data reflect reality in veterinary medicine? The authors note that veal calves receive antibiotic treatments more often than other farm animals; whether the situation in Belgium occurs elsewhere remains unclear but seems likely. Rational use of antibiotics needs to be extended far beyond hospital walls to slow the increase of resistance!
Thomas Glück, MD Published in Journal Watch Infectious Diseases May 9, 2012
Citation(s): Pardon B et al. Prospective study on quantitative and qualitative antimicrobial and anti-inflammatory drug use in white veal calves. J Antimicrob Chemother 2012 Apr; 67:1027.
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Ann Intern Med 2012 Apr 17; 156:551
Epidural Steroids, Etanercept, or Saline Injections for Subacute Sciatica?
No significant benefit was found for drug treatment relative to saline.
Treatments for lumbosacral radiculopathy remain suboptimal, and data to support using the most common invasive intervention, epidural steroid injections, have been conflicting. In this double-blind U.S. study, 84 people with lumbosacral radiculopathy who had not responded to conservative therapy and had evidence of corresponding abnormalities on magnetic resonance imaging were randomized to receive two epidural injections (2 weeks apart) of methylprednisolone (60 mg), etanercept (4 mg), or saline. Etanercept was studied because experimental evidence suggested that cytokine inhibitors can have favorable effects on injured nerve roots. All patients also received bupivacaine. The primary outcome was leg pain, rated on a 0-to-10–point scale.<
At baseline, the mean level of leg pain was about 6.2. At 1 month, mean pain scores declined more in the epidural steroid group (–3.6 points) than in the etanercept group (–3.0 points) or in the saline group (–2.5 points), but no comparisons between groups reached statistical significance. At 3 months, 50% of the steroid group, 42% of the etanercept group, and 43% of the saline group reported positive outcomes (≥50% reduction in pain and no need for further intervention).
Comment: This trial did not show a significant benefit of epidural injections with steroids or etanercept relative to saline injections. Although the small sample size could have contributed to the lack of statistical significance at 1 month, that either intervention would have proved to be superior to saline injections at 3 months is unlikely. The findings support conservative management during the early stages of sciatica.
Jamaluddin Moloo, MD, MPH Published in Journal Watch General Medicine May 8, 2012
Citation(s):Cohen SP et al. Epidural steroids, etanercept, or saline in subacute sciatica: A multicenter, randomized trial. Ann Intern Med 2012 Apr 17; 156:551.
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Bottle-Feeding Linked to Greater Infant Weight Gain, Regardless of Milk Type
The more infants are fed by bottle, the more weight they gain during the first year of life — regardless of whether they're receiving formula or expressed breast milk — according to an Archives of Pediatrics and Adolescent Medicine study.
U.S. researchers followed nearly 1900 mother-infant pairs over the course of 1 year. Compared with infants who were breast-fed, those who were bottle-fed gained 71 g more per month when given nonhuman milk only and 89 g more when given breast milk only. In addition, among infants who received breast milk only, those fed frequently by bottle gained more weight than those fed frequently at the breast.
The authors write that bottle-fed infants "may gradually lose their ability to self-regulate" their consumption. Editorialists, meanwhile, list several reasons for bottle-feeding (e.g., working mothers), and conclude that when offering feeding advice, pediatricians should be "mindful of the gap that always exists for parents between doing what is ideal ... and doing what is possible."

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