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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 2, 2014

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How Do Fruits and Veggies Love us? Let Us Count the Ways
High Levels of Calcium in Blood and Urine Seen in Older Women Given Supplements
With Pricier vaccines, Some Doctors Stop Offering Immunizations
Pertussis May Be a Cause of Persistent Cough Even in Vaccinated Children
Pregnenolone for Bipolar Depression
Must Serum Testosterone Be measured First Thing in the Morning?
France to Use Avastin and Not Lucentis
Progress Report on ACA Finds More Covered, But Warns on Cost of Care
Excessive Alcohol Use to Blame for 10% of Deaths Among U.S. Adults
Cesarean Birth: One and Done?
Whither the Routine Pelvic Exam?
Over-Fortified Cereals Risky to Kids

MM: The benefits of adding several servings of fruits and veggies to your diet is hardly a surprise. What is also not a surprise is that very few of us actually consume any fruits or veggies on a regular basis. The Standard American Diet (SAD), other than ketchup and french fries, is almost devoid of fruits and vegetables and contributes to a plethora of chronic diseases that tend to be centered on obesity, diabetes, malnutrition and metabolic syndrome.
How Do Fruits and Veggies Love us? Let Us Count the Ways
By Christine Sadlowski
Edited by David G. Fairchild, MD, MPH
The oft-cited five servings per day of fruits and vegetables was the optimal amount for limiting overall and cardiovascular mortality, but not cancer mortality, in a BMJ meta-analysis.
Culling data from 16 prospective, observational studies conducted since 1950, researchers found that the more fruits and vegetables people consumed each day (up to five total servings), the lower the risk for all-cause mortality. (A serving was defined as roughly 80 g, or 2.8 oz., of fruit or vegetable.)
In particular, for consumption of five servings versus no servings daily, the hazard ratio was 0.74 for all-cause mortality. Two servings of fruit and three of vegetables appeared to provide optimal benefits. In addition, each fruit or vegetable serving was associated with a 4% reduction in cardiovascular mortality. There was no significant association with cancer mortality.
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MM: The culprit in this case appears to be excessive calcium, not Vitamin D3. I feel that it is important to state this as vitamin D3 seems to be demonized more and more in recent days. I still maintain that vitamin D3 is most likely the most universally effective nutritional supplement for the largest part of the population available today. Target blood levels should be 60-80ng/ml and should be measured initially to determine if and how much a person is vitamin D3 deficient and should be re-measured several months later after initiating a vitamin D3 supplement program to determine a person's progress in attaining an optimal blood level of D.
High Levels of Calcium in Blood and Urine Seen in Older Women
Given Supplements

By Kelly Young
Edited by Susan Sadoughi, MD, and Lorenzo Di Francesco, MD, FACP, FHM
Hypercalcemia and hypercalciuria are common in older women taking vitamin D and calcium supplements, according to a prospective study in Menopause.
Roughly 150 postmenopausal white women who were insufficient in vitamin D were randomized to receive vitamin D3 (400–4800 IU/day) or placebo. In addition, all participants were given calcium citrate supplements based on their dietary calcium intake, with a goal of 1200 mg of calcium daily.
Over a year, 9% of women developed hypercalcemia, and nearly a third developed hypercalciuria, with little overlap between the two groups. There was no association between the dose of vitamin D and hypercalcemia or hypercalciuria. Both conditions were observed in women taking placebo plus calcium, leading the authors to caution that "even a modest calcium supplementation of 600 mg/day may be too high for some women."

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MM: It is interesting that as vaccines are more greatly promoted than ever before, prices have risen to become quite cost prohibitive for the pay out-of-pocket consumer. Could it be that vaccine manufacturers are simply laying the groundwork for big paybacks from socialized medicine payors? As the Affordable Care Act (ACA) is rolled out, we know that government payors will negotiate better than current retail pricing from vaccine manufacturers and the manufacturers will be negotiating those reimbursements from a much higher plane than they have been on in the past. Also consider that vaccine manufacturers have already been awarded immunity-like status by the federal government should a person have a less than beneficial response to a vaccine.
Once again, irrespective of your opinion of vaccines, it might not be a bad investment to look at some of these manufacturers for your investment portfolio.

With Pricier vaccines, Some Doctors Stop Offering Immunizations
By Kelly Young
Edited by Susan Sadoughi, MD, and Jaye Elizabeth Hefner, MD
Some vaccines have tripled in price over the past two decades, leading some pediatricians to stop offering them altogether, an idea that "is as unthinkable as a baker not selling bread," the New York Times reports.
In 1986, the five recommended vaccines cost $215. By 2014, these same vaccines cost $937. Moreover, eight new vaccines were added in the intervening years for an additional $1255.
Older vaccines have been revamped at higher prices, while newer vaccines, like the pneumococcal vaccine Prevnar 13, "have entered the market at once-unthinkable prices." Some physicians say they are losing money with every vaccination. A recent survey found that roughly 40% of doctors didn't offer all of the recommended childhood vaccines. Another survey found that a third of doctors are contemplating dropping vaccinations altogether.
This has left parents scrambling to find providers for immunizations. One Texas woman told the Times that she called 10 pediatricians before finding one that would vaccinate her son.

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MM: The pertussis vaccine appears to be ineffectual. This is another reason to be very circumspect before initiating the entire battery of potential vaccines.
Pertussis May Be a Cause of Persistent Cough Even in Vaccinated Children
By Cara Adler
Edited by David G. Fairchild, MD, MPH, and Richard Saitz, MD, MPH, FACP, FASAM
Nearly one in five school-age children in the U.K. visiting a doctor for persistent cough has evidence of recent pertussis infection despite being fully vaccinated, according to a prospective cohort study in BMJ.
U.K. researchers measured antipertussis toxin IgG titers in some 280 children (aged 5 to 15 years) who presented to 22 primary care practices with cough persisting for 2 to 8 weeks. Most patients (77%) were fully vaccinated. (The U.K. schedule includes vaccinations at 2, 3, and 4 months of age, plus a preschool booster 3 years after the last dose; the U.K. has not yet introduced an adolescent booster).
The researchers found evidence of recent pertussis infection in 20% of the children overall — and in 18% of those who were fully vaccinated. Older children who received the preschool pertussis booster more than 7 years previously were three times more likely to have pertussis than younger children who received the booster more recently.
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MM: We have used pregnenolone as an adjunctive measure for adrenal fatigue. Although we typically recommend 5-25mg daily, this study demonstrates that much higher doses may be given for extended periods of time. This study indicates that pregnenolone may show limited beneficial results for Bi-polar Depression (BPD)and may be useful as an adjunctive treatment forpatients who are looking for natural alternatives or ways of decreasing their antidepressant doses to limit or prevent dose related adverse reactions and side effects.
Neuropsychopharmacology 2014 Jun 11
Pregnenolone for Bipolar Depression
Only one beneficial effect — and on only a secondary measure — was identified at the end of this clinical trial
Treatment of bipolar depression continues to vex clinicians and distressed patients alike. Researchers conducted a randomized, placebo-controlled, 12-week, clinical trial of the endogenous neurosteroid pregnenolone given adjunctively (titrated to 500 mg/day) in 73 bipolar patients with depression. Research evidence exists that pregnenolone is involved in mood regulation in animals and modulates mood-relevant neural circuits in humans. One author has a patent pending on this use.
Although pregnenolone had a significantly greater remission rate than placebo at study end on a scale for patient-rated depressive symptoms (61% vs. 37%), this was not observed with the Hamilton Rating Scale for Depression (HRSD; 47% and 51%), and neither measure showed medication–placebo differences in response rates. A trend in favor of pregnenolone on the HRSD in weeks 1–6 disappeared totally in weeks 7–12. Changes in metabolic intermediates correlated negatively with changes on a clinician-rated anxiety scale but not with changes on either depression scale. Pregnenolone was well tolerated by patients.
Comment: Clinicians tempted to use this strategy in bipolar patients with treatment-resistant depressive episodes should be aware: This study did not control for multiple testing and essentially had negative findings despite highlighting one positive finding. In addition, the high remission rates with placebo suggest improvements in depression that are often just part of the natural course of the illness (and may be more likely to occur with longer trial duration). The authors are to be commended for doing a 12-week rather than a 6-week study, which allowed the limitations of this medication strategy to become evident. Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
Citation(s): Brown ES et al. A randomized, double-blind, placebo-controlled trial of pregnenolone for bipolar depression. Neuropsychopharmacology 2014 Jun 11; [e-pub ahead of print].
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J Urol 2014 Jul; 192:165
Must Serum Testosterone Be measured First Thing in the Morning?
Diurnal variation in serum testosterone appears to diminish after age 45.
Because a man's serum testosterone level varies diurnally, guidelines generally advise measuring it in early morning, when it tends to be highest. However, diurnal variation becomes less prominent as men age. In this study, U.S. researchers examined initial serum testosterone levels measured in 2600 men who attended an erectile dysfunction clinic. Results were analyzed according to patient age and according to the time blood was drawn (between 7 am and 2 pm; too few samples were drawn after 2 pm for accurate analysis).
In men younger than 45, diurnal variation was confirmed; mean levels were ≈600 ng/dL at 7 am, 500 ng/dL at 10 am, and 400 to 450 ng/dL by 2 pm. However, within each 5-year age grouping for older men (age, ≥45), mean serum testosterone levels differed only minimally at all times from 7 am to 2 pm.
Comment: This analysis suggests that timing of testosterone measurement becomes less important as men age, at least between 7 am and 2 pm. A limitation of the study is that diurnal variation was inferred from averages of single testosterone measurements in groups of men and not from multiple serial measurements in individual men. However, the results are probably valid, given the large number of participants.
Citation(s): Welliver RC Jr et al. Validity of midday total testosterone levels in older men with erectile dysfunction. J Urol 2014 Jul; 192:165.
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MM: It appears that France has followed Italy's lead in cost cutting approaches to healthcare that make sense. It is a good thing when casts may be drastically reduced and patient care is virtually unaffected. I applaud the French government in their decision to use Avastin for Age Related Wet Macular Degeneration. (wet AMD).
France to Use Avastin and Not Lucentis
In order to cut healthcare costs, the French government plans to authorize the use of Avastin as an alternative eye disease treatment to the much pricier Lucentis. The government announced that it has introduced an amendment to its social security budget bill that would allow doctors to use Avastin as a treatment for age-related macular degeneration. The use of the drug, which costs 30 times less than Lucentis, could bring the state annual savings of at least 200 million euros ($273 million).
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MM: Anyone who truly believed that the Affordable Care Act would be:
a) affordable,
b) Universally available,
c) able to sustain the high quality of healthcare that Americans have come to expect, and
d) Not going to bankrupt the economy unless significant cuts to care are established, were not particularly realistic in their expectations. Drug manufacturers, the cornerstone of American medical treatments, have systematically increased their prices, vaccine manufacturers have seen a 10 fold increase in their prices and payments to practitioners have continued to plummet thereby devaluating perhaps the most important part of the American healthcare system. The same drugs are available worldwide but the practitioners that are available in this country to diagnose and treat are unique to America. failure to compensate these heroic and exceedingly competent practitioners in a manner that is appropriate to their training and expertise will ultimately result in the downgrading of care in this country.

Progress Report on ACA Finds More Covered, But Warns on Cost of Care
By Joe Elia,  Edited by Susan Sadoughi, MD, and Lorenzo Di Francesco, MD, FACP, FHM
A useful overview of the Affordable Care Act and its effects so far on U.S. health care offers three conclusions.
First, coverage has expanded. The Congressional Budget Office estimates that the ACA will decrease the number of uninsured by some 12 million this year.
Second, in those states not accepting expansion of Medicaid eligibility, it's estimated that some 5 million uninsured people will remain without insurance, although it's expected that most states will eventually accept the expansion.
Finally, coverage expansion is being made affordable, in part, through the use of restricted networks of providers. However, that strategy's usefulness will evaporate in the face of increasing costs of care. Innovation in delivering care "is the next great challenge facing the nation."
The overview's authors, writing in the New England Journal of Medicine, are both members of the Commonwealth Fund, a nonpartisan foundation.
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MM: When we think about the dangers that are faced in society we often discount the things that make us comfortable. Alcohol is one of those things. Insurance companies look at activities that are considered dangerous like sky diving or scuba diving and immediately raise our rates or simply deny coverage for these activities but I certainly do not recall an insurance agent ever raising his or her eyes when the answer to alcohol use or acetaminophen or ibuprofen use was in the affirmative. Yet, these items are all much more deadly than being trained to breathe underwater or jump out of an airplane. They merely lead to a more insidious and acceptable demise.
Excessive Alcohol Use to Blame for 10% of Deaths Among U.S. Adults
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
One in ten deaths among working-age adults in the U.S. is attributable to excessive alcohol consumption, according to an analysis published in Preventing Chronic Disease.
CDC researchers used an online tool (the Alcohol-Related Disease Impact application) to estimate the number of deaths from 54 alcohol-related causes across the U.S. from 2006 through 2010. During that time, the annual rate of alcohol-attributable deaths was 27.9 per 100,000 population. The most frequent chronic cause of alcohol-attributable death was alcoholic liver disease, while the most common acute cause was motor vehicle accident.
Overall, 9.8% of all deaths among adults aged 20 to 64 were due to excessive alcohol use.
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MM: I am not completely surprised at the statistical reduction in subsequent births following caesarean section. After all, unless you are a Hollywood actress, shouldn't most C-sections be medically necessary and therefore logically, it means that the mother is at greater risk from a pregnancy? These are the logical and medically limited thoughts but I think that there are other things at play here. Let's look at the elective c-section that makes scheduling a birth more convenient. This was certainly popular in the 1990's with our very fast paced lives that new parents didn't want disrupted by the unknown timing of a vaginal delivery. Little did they realize that the next 20-30 years of their lives would be disrupted by unscheduled events.
Obstet Gynecol 2014 Jul; 124:111
Cesarean Birth: One and Done?
Likelihood of subsequent pregnancy is lower after cesarean delivery.
Most population-based work on the effects of the rising U.S. cesarean rate has focused on acute and longer-term surgical complications associated with primary and repeated procedures. Now, investigators analyzed National Survey of Family Growth data to determine whether women who have undergone one or more cesarean deliveries are more likely than those with only vaginal deliveries to continue childbearing. The 6526 women in the study population represented 33 million U.S. women when the survey's sample weights were taken into account.
Overall, of women with at least one birth, 70% had a second delivery, 30% a third, and 11% a fourth. Young age, higher income, desired prior pregnancy, and having had only vaginal births were most consistently associated with having additional pregnancies. Women with more prior cesarean deliveries were increasingly less likely to have subsequent births (a dose–response relation); however, low-income women were more likely than higher-income women to have fourth births after two or three prior cesarean deliveries.
Comment: These results confirm that women are less apt to continue childbearing after cesarean delivery than after vaginal delivery — perhaps because women with one or more cesareans are less likely to desire more births, are more influenced by provider counseling, or are more likely to experience subfertility than women with only vaginal deliveries. Sterilization and use of long-acting contraception were not studied here, and might also differ by mode of delivery. I am troubled by the disparity between women of higher and lower socioeconomic status, which suggests that costs of repeated cesarean deliveries may be disproportionately borne by women at greater baseline risk for adverse outcomes. Assessment of a woman's reproductive intentions — and an understanding that intention does not underlie all behavior — should be more closely incorporated into obstetric care, particularly when making decisions about delivery mode.
Citation(s): Masinter LM et al. Likelihood of continued childbearing after cesarean delivery in the United States. Obstet Gynecol 2014 Jul; 124:111. (http://dx.doi.org/10.1097/AOG.0000000000000294)
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MM: I am rather old school and feel that it is a good thing for patients and their caregivers to interact. Even if some of those interactions are a bit awkward or uncomfortable to start with, they help to define that a caregiver must be made privy to a person's most intimate problems in order to provide care and/or treatment for those problems. Clinicians should not be merely detectives looking for hidden signs. Patients must be able to communicate with their caregivers in an open and confidential manner. An intimate examination may not always disclose a localized problem at a young age but it certainly defines to a patient that everything is safe and appropriate to communicate to their appropriate health care provider.
Ann Intern Med 2014 Jul 1; 161:46
Whither the Routine Pelvic Exam?
The American College of Physicians recommends against performing routine pelvic examinations as part of well-women visits
Sponsoring Organization: American College of Physicians (ACP)
Target Population: Clinicians who conduct well-woman visits
Background and Objectives
Women and clinicians alike have typically perceived vaginal speculum and bimanual examinations as an integral part of the well-woman visit. Now, the ACP has issued evidence-based guidance challenging this time-honored practice. The ACP's review indicates that routine pelvic examination is not useful in screening for malignancies other than cervical cancer, can lead to unnecessary additional evaluation and surgery, often causes discomfort and embarrassment, and may deter some women from receiving gynecologic care.
Key Recommendations
Routine pelvic examination is not recommended in asymptomatic nonpregnant adult women. This recommendation does not apply to routine cervical cancer screening. Such screening should include vaginal speculum examination with visual inspection of the cervix and collection of cervical specimens, but not bimanual examination. Screening for chlamydia and gonorrhea can be accomplished with nucleic acid amplification testing of urine specimens or self-collected vaginal swabs.
Comment: In 2012, the American College of Obstetricians and Gynecologists recommended that speculum and bimanual examinations be part of annual well-women visits in women 21 and older (NEJM JW Womens Health Aug 23 2012). As an editorialist notes, obstetrician-gynecologists universally continue to perform routine pelvic examinations — and ending this practice represents a “formidable challenge.” During well-women visits, I routinely encounter patients with bacterial vaginosis, mucopurulent cervicitis, severe vulvovaginal atrophy, advanced vulvar lichen sclerosus, and cervical polyps who did not report any symptoms in histories taken before their examinations. While I agree that pelvic examinations are not effective in screening for ovarian cancer, my anecdotal observations suggest that routine pelvic examinations can be clinically valuable. Although most of my adult patients continue to prefer such examinations, since 2012 (coincident with updated cervical cancer screening guidelines [NEJM JW Womens Health Apr 12 2012]) I have been selectively performing them less often. For adolescents as well as patients who may find regularly occurring pelvic examinations emotionally stressful, I agree with the new ACP guidance that not performing these examinations routinely is appropriate.
Citation(s): Bloomfield HE et al. Screening pelvic examinations in asymptomatic, average-risk adult women: An evidence report for a clinical practice guideline from the American College of Physicians. Ann Intern Med 2014 Jul 1; 161:46.

Qaseem A et al. Screening pelvic examination in adult women: A clinical practice guideline from the American College of Physicians. Ann Intern Med 2014 Jul 1; 161:67. (http://dx.doi.org/10.7326/M14-0701)

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MM: I truly question the validity and the Evidence Based Medicine for claiming the potential deleterious effects of these "vitamin and nutrient overdoses". Note that the claims of danger are all hedged by the word "can". This is legally not a definitive statement. Merely a possibility. Without any clinical evidence and/or history of problems at these doses, it is highly questionable whether this is any concern at all or merely a hyper-panic induced commentary.
Over-Fortified Cereals Risky to Kids
By Amy Orciari Herman Edited by Susan Sadoughi, MD, and Lorenzo Di Francesco, MD, FACP, FHM
Children who eat fortified cereals and snack bars are at risk for consuming potentially dangerous levels of niacin, vitamin A, and zinc, according to a report from the Environmental Working Group.
Upon reviewing nutrition information for over 1500 breakfast cereals and 1000 snack bars, the EWG found that nearly 115 cereals were fortified with 30% or more of the adult recommended Daily Value for niacin, vitamin A, or zinc, and about 30 snack bars were fortified with 50% or more. Such products include General Mills Total Raisin Bran, Kellogg's Cocoa Krispies, and Balance Bars.
When children eat these products, they put themselves at risk for overexposure. Among the potential side effects: excessive niacin can cause skin reactions, too much vitamin A can lead to liver damage, and excessive zinc can inhibit immune function.
The EWG calls for the FDA to mandate age-specific Daily Value information on nutrition labels. In the meantime, the group says children should consume foods with no more than 20%-25% of the adult Daily Value for these nutrients per serving.

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