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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 15, 2014

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Vitamin D Supplementation Associated with Improved LDL Cholesterol
   Among Postmenopausal Women
E-Cigarettes May Encourage Use of Conventional Cigarettes Among Teens
A Second Infant Reportedly Cleared of HIV After Early Therapy
What Predicts Continued Sexual Activity in Midlife Women?
Proton-Pump Inhibitors vs. Histamine-2 Receptor Antagonists to Prevent Stress Gastritis
Avastin and Lucentis in Italy
Do Drug Benefit Managers Reduce Health Costs?
Even Low-Range Prehypertension BP Seems Associated With Increased Stroke Risk
Reduction in Obesity Prevalence in Preschoolers
Examining the Link Between Poverty and Obesity

MM: Even with this very moderate, in fact, nominal dose of vitamin D-3 and a moderate amount of calcium, postmenopausal women saw an improved cholesterol profile. This means that they were more "heart healthy" with a lower likelihood of stroke or other Cardiovascular (CV) event. I contend that this nominal D dose and change in blood levels was still insufficient to get these patients to a truly healthy and appropriate D level, and if they were brought to levels in the 60-80ng/ml range, then they would have seen even greater clinical and numerical benefit and improvement.
Vitamin D Supplementation Associated with Improved LDL Cholesterol Among Postmenopausal Women
By Amy Orciari Herman
Postmenopausal women who gain elevated serum 25-hydroxyvitamin D3 through supplementation see reductions in LDL cholesterol, according to a study in Menopause.
Researchers measured lipids among some 600 Women's Health Initiative participants who'd been randomized to receive either daily vitamin D (400 IU) plus calcium (1000 mg), or placebo. At 2 years, the mean serum vitamin D level was significantly higher in the supplement versus placebo group (24.3 vs. 18.2 ng/mL). Further, supplement recipients had a 4.5-mg/dL decrease in LDL cholesterol relative to placebo recipients — an effect mediated by serum vitamin D levels.
The researchers conclude: "Although further studies are needed to determine whether these findings translate into clinically meaningful results, this should be viewed as a reminder that women at higher risk for 25OHD3 deficiency should consider supplementation" with calcium and vitamin D.

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MM: The e-cigarette may be a good idea for people who are smokers and want to quit as it satisfies the hand to mouth compulsion that accompanies the physiological dependence of smoking. It is not surprising that any learned habit is one that may be repeated. This is especially true when there is a reward for the user. That is the case with the conversion from the e-cigarette to the conventional type. Nicotine and its physiological effects are the short term reward. Unfortunately, the data tends to point towards mostly negative impacts on teenswhen it comes to e-cigarettes.
E-Cigarettes May Encourage Use of Conventional Cigarettes Among Teens
By Amy Orciari Herman
Adolescents who use electronic cigarettes are more likely than nonusers to smoke conventional cigarettes, according to a cross-sectional study in JAMA Pediatrics.
Researchers examined National Youth Tobacco Survey data on some 40,000 middle and high school students from 2011 and 2012. Rates of current e-cigarette use doubled during that time period (from 1% to 2%).
Among students who had ever tried conventional cigarettes, current e-cigarette use correlated positively with ever having smoked 100 or more conventional cigarettes (odds ratio, 7.4) and with current smoking (OR, 7.9). In addition, among current conventional smokers, concurrent e-cigarette use was associated with heavier smoking.
The researchers conclude: "These results suggest that e-cigarette use is aggravating rather than ameliorating the tobacco epidemic among youths." A researcher from the American Cancer Society, however, is skeptical: "The data in this study do not allow many of the broad conclusions that it draws," he told the New York Times. For example, it's possible that adolescents who use e-cigarettes are heavier smokers to begin with.
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MM: This is an interesting article in that it addresses early detection and treatment of an infant while its immune system is still at the immature level. The question of whether these viral infections are removed from the body or will merely lay dormant waiting for an opportunity later in life to expose their true menace remains to be seen.
Arch Intern Med 2011 Aug 8/22; 171:1363
A Second Infant Reportedly Cleared of HIV After Early Therapy
By Joe Elia
A California baby is apparently the second case of an infant infected perinatally with HIV and showing no signs of infection after beginning early antiretroviral therapy. Details have been presented at the Conference on Retroviruses and Opportunistic Infections. The presentation also updates the progress of the earlier case from Mississippi.
The California baby was started on a three-drug antiretroviral regimen at 4 hours of age. The viral load was at undetectable levels by 11 days of age. Now 9 months old, the baby remains on antiretroviral maintenance therapy and is seronegative.
The Mississippi baby, now 41 months old, has been off antiretroviral therapy for almost 2 years. The child remains HIV seronegative.
Asked to comment, Paul Sax, author of the NEJM Journal Watch blog "HIV and ID Observations," wrote that the clinical implications of this case — most notably, whether the baby is in fact cured of HIV — remain uncertain since the baby is still on antiretroviral therapy.
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MM: When we say '"sexual activity" we generally associate that with intercourse but simple touching, kissing and close body contact may be considered by many to be as satisfying as the actual act itself. Where the conflict tends to arise is when both partners are not on the same page and are not communicating their perspective and personal needs to each other..
JAMA Intern Med 2014 Feb 10
What Predicts Continued Sexual Activity in Midlife Women?
No surprise here: If women think sex is important, they keep it in their lives.
Healthy sexual function contributes positively to health-related quality of life but can be adversely affected by aging. What predicts continued satisfying sexuality in women?
In year 4 of an 8-year longitudinal cohort study known as STRIDE, 354 of 602 women aged 40 to 65 reported sexual activities with a partner during the previous 6 months. At year 8, 228 of these 354 women remained sexually active with partners. In multivariable analysis, women who were white, had lower body-mass index, and placed a high importance on sex were significantly more likely to maintain sexual activity. Scores on the Female Sexual Function Index (FSFI), a validated instrument measuring female sexual function (sexual desire, arousal, lubrication, orgasm, satisfaction, pain) were generally low, did not significantly differ between groups, and were not associated with continued sexual activity. +
Comment: It makes sense that women who consider sexual activity important would maintain it as they age. Perhaps the most interesting finding is that seemingly low sexual function as measured by the Female Sexual Function Index did not preclude continued sexual activity. The authors speculate that enjoyable sexual activity in midlife and older women may include kissing, intimate touch, and close body contact instead of (or in addition to) intercourse, the focus of the FSFI. These authors defined sexual activity as including a partner, but women without partners also can continue to enjoy sexual activity.
Citation(s): Thomas HN et al. Sexual activity in midlife women: Importance of sex matters. JAMA Intern Med 2014 Feb 10; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamainternmed.2013.14402)[e-pub ahead of print]
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MM: Although there are unanswered questions that arise regarding the ratio of very sick patients who may have received PPI's and therefore been at higher risk for complications, we cannot disregard such demonstrative statistical results. PPI's are not the safest medication on the planet as many clinicians and Big Pharma would have us believe. Are they a complete demon? No to that as well. They must, however, be used with prudence as should statins, antibiotics or any medication.
JAMA Intern Med 2014 Feb 17
Proton-Pump Inhibitors vs. Histamine-2 Receptor Antagonists to Prevent Stress Gastritis
A surprising finding of increased risk for gastrointestinal bleeding with PPI use is questionable due to study weaknesses.
Critically ill patients are at risk for developing gastrointestinal bleeding (GIB) from stress-related mucosal disease. Prophylactic acid reduction therapy using either proton-pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) is common. However, acid reduction is associated with an increased risk for pneumonia and has been suggested to increase the risk for Clostridium difficile infection (CDI; NEJM JW Gastroenterol Nov 12 2013, NEJM JW Gen Med Jul 31 2012, NEJM JW Gastroenterol Dec 23 2013).
To compare frequencies of GIB, pneumonia, and CDI associated with PPI use versus H2RA use in this setting, investigators retrospectively reviewed patient data from a commercial administrative database. Study patients required mechanical ventilation for at least 24 hours and received either a PPI or an H2RA. Outcomes were defined as secondary diagnoses of GIB, pneumonia, or CDI (based on ICD-9 codes) that occurred ≥48 hours after initiation of ventilation. Other potential covariates were collected.
In 35,312 patients, 62% received PPIs and 38% received H2RAs. All outcomes were more common in the PPI group (GIB, 5.9% vs. 2.1%; pneumonia, 38.6% vs. 27.0%; and CDI, 3.8% vs. 2.2%; P<0.001 for all). Adjustment for covariates, adjustment for a propensity score for acid suppressant choice, and sensitivity analyses did not alter the results.
Comment: In an accompanying editorial, the authors outline many methodological limitations of this retrospective study of administrative data. They note the possibility of ascertainment bias from misclassification using ICD-9 codes (suggested by high incidences of outcomes) and the absence of a biologic model to explain the increased risk for gastrointestinal bleeding with PPIs (in the face of many studies showing the superiority of PPIs to prevent GIB). Residual indication bias might also be present if the propensity score did not adequately control for possible prescription of PPIs to the sickest patients. Finally, the severity and clinical significance of the outcomes, particularly GIB, cannot be determined. Nonetheless, these provocative results should prompt future randomized trials.
Citation(s): MacLaren R et al. Histamine-2 receptor antagonists vs. proton pump inhibitors on gastrointestinal tract hemorrhage and infectious complications in the intensive care unit. JAMA Intern Med 2014 Feb 17; [e-pub ahead of print].
Kim R and Goss CH.
Unintended consequences of therapy in the intensive care unit. JAMA Intern Med 2014 Feb 17; [e-pub ahead of print].
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MM: This penalty is a mere drop in the bucket. Ophthalmologists are reimbursed by Medicare about $50/shot for Avastin and about $2200 for Lucentis. The doctors get the same service fee for each shot! The drugs are virtually identical in chemical structure and effectiveness. Novartis and Roche are gouging the Italian government, the U.S. government and any other government that is paying this disproportional amount for Lucentis. When a country is in the financial straits that Italy is, it is criminal to allow for this type of corporate corruption and theft from the people.
Avastin and Lucentis in Italy
Italy's antitrust regulator fined Novartis AG and Roche Holding AG $251 million for allegedly colluding to prevent the use of Roche's Avastin cancer drug as a treatment for age-related macular degeneration in favor of a more expensive drug, Lucentis, that the two companies market jointly.
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MM: PBM's serve a singular function. That function is to bully providers and collect the skim. They penalize doctors, hospitals and pharmacies in the guise of cost-effectiveness and cost-containment but then fail to return the difference to the consumer. They claim that their efforts will reduce the cost of insurance and healthcare while simultaneously claim to be working on the behalf of the consumer. This is simply not so. Insurance rates continue to rise. Reimbursements to providers continue to diminish. healthcare quality fails to improve and the PBM's get richer. This is simply wrong!
Do Drug Benefit Managers Reduce Health Costs?
While cutting goes on in health care, one of the biggest and least understood players is getting bigger and richer, the Pharmacy Benefit Managers (PBMs), which include CVS Caremark and Express Scripts. The roles of PBMs have expanded from simply handling prescription billing about 15 years ago to deciding which drugs insurers cover, what they cost, and how much pharmacies are reimbursed for them. However, some state lawmakers are trying to rein them in as legislation is active in 14 states that would require more pricing disclosure by these companies.
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MM: This same group of patients that are at risk of stroke when in a pre-hypertensive state are the same group who are at increased risk of falling and breaking bones when their blood pressures are too aggressively controlled. There are numerous factors that will have an effect on stroke risk. These include diet and lack of exercise. At the very least, lifestyle changes should be considered before aggressive BP reduction in pre-hypertensive patients.
Even Low-Range Prehypertension BP Seems Associated With Increased Stroke Risk
By Kelly Young
Prehypertension is associated with increased stroke risk, even after controlling for other cardiovascular risk factors, according to a new meta-analysis in Neurology.
In 19 prospective cohort studies including more than 750,000 people, 25% to 54% of participants had prehypertension — a blood pressure reading of 120-139/80–89 mm Hg. After multivariable adjustment, prehypertension was associated with increased risk for stroke, compared with optimal BP (relative risk, 1.66). BP levels at the higher range of prehypertension (130-139 systolic BP) were associated with greater risk than levels at the lower end, but even systolic BPs in the 120s carried increased stroke risk.
The authors recommend lifestyle intervention for patients with prehypertension. They say that future randomized trials should assess drug treatments in high-risk patients, such as those with high-range prehypertension along with other risk factors.
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MM: It's good to get positive reinforcement when something good occurs but we must not rest on our laurels. We must make weight control a lifelong goal. Obesity through life will increase the risk of diabetes, stroke and heart attack. It will challenge the immune system and increase the risk of asthma, arthritis and gout. Finally, obesity puts reproduction at risk and has a potential negative effect on the developing fetus and its future.
JAMA 2014 Feb 26; 311:806
Reduction in Obesity Prevalence in Preschoolers
However, overall prevalence in youth and adults remains high
Obesity remains a public health challenge, although the trend of increasing prevalence might be stabilizing (NEJM JW Pediatr Adolesc Med Jan 25 2012). Numerous national efforts have been undertaken to attack this problem. CDC researchers analyzed current trends in childhood and adult obesity by comparing National Health and Nutrition Examination Survey data between 2003–2004 and 2010–2012.
Overall obesity prevalence did not change significantly and remained high in children (age range, 2–19 years, 17%) and adults (age, ≥20 years; 35%). However, among children aged 2 to 5 years, obesity prevalence significantly declined from 14% in 2003–2004 to 8% in 2010–2012.
Comment: This analysis offers a glimmer of positivity about the national epidemic of obesity. Although a decline in the prevalence of obesity in preschool children is encouraging, overall prevalence has not declined. Therefore, we cannot relax our attempts to encourage healthy eating and lifestyles. A reduction in the overall prevalence of childhood obesity would be nice to see in the next analysis.
Citation(s): Ogden CL et al. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA 2014 Feb 26; 311:806.

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MM: It's not a surprise that when people have more money and are educated as to what their best health choices are, they will take advantage of that knowledge and benefit from it. It is also not a surprise that when people do not have the financial ability to purchase optimal foods, they will buy what they can to stave off hunger. We look at the statistics that demonstrate poorer health in poverty stricken areas and say that we can't simply correct these problems by throwing money at them but this study seems to argue that point.
JAMA 2014 Mar 5; 311:915
Examining the Link Between Poverty and Obesity
Increased income from casinos was associated with decreased risk for overweight or obesity in American Indian children.
Poverty is a social determinant of childhood obesity. Investigators assessed whether increased income from new American Indian casinos reduced the risk for obesity in children aged 7 to 18 years in 117 school districts in California between 2001 and 2012. They evaluated economic and obesity measures in 57 districts before and after they opened or expanded casinos, 24 districts with casinos that did not expand, and 36 districts without casinos.
Among the 57 districts with new or expanded casinos, the mean increase in slot machines was 13 per capita. Overall, each slot machine per capita gained was associated with an increase in average per capita annual income of $541 and a 0.6% decrease in the percentage of American Indians living in poverty on tribal land. Among American Indian children, each additional slot was associated with a decrease in body-mass index z-score of 0.003 and a decrease in the probability of overweight or obesity of 0.19 percentage points. No spillover effects were observed among white children in these districts.
Comment: This study attempted to evaluate the effect of increased economic resources on the risk for obesity in American Indian children. The complex social and biological determinants that might have led to the salutary effects of increased economic resources on body weight are not evaluated. Nonetheless, reducing poverty should be a priority for improving the health of children.
Citation(s): Jones-Smith JC et al. Association between casino opening or expansion and risk of childhood overweight and obesity. JAMA 2014 Mar 5; 311:929.
PubMed abstract (Free) Halfon N.Socioeconomic influences on child health: Building new ladders of social opportunity. JAMA 2014 Mar 5; 311:915.

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