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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 12, 2014

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Well-Heeled Healers: A Few Doctors Account for Large Chunk of Medicare Payouts
Guidelines on Preventing Catheter-Associated UTI's Updated
Vitamin Doubt: Evidence Still Murky on D's Benefits
Dietary Fats: Corrected Meta-Analysis Raises a Fuss
Micronutrient Treatment for Adult ADHD
USPSTF Draft Recommendation Advises Aspirin for Women at Risk for Preeclampsia
What Do Women Use for Perineal Hygiene and Vulvovaginal Symptom Relief?
Study Suggests Link Between Viagra and Melanoma
AAN Guideline: Oral Cannabis May Help Ease MS Symptoms, Uncertainty Over
  Other Therapies
CDC Reports on Healthcare-Associated Infections
Glucose Measurements Don't Improve Cardiovascular Risk Assessment
ACE Inhibitors Linked to Better CV Outcomes Than ARB's in Patients with Diabetes
Epidural Anesthesia Lengthens Labor's Second Stage More than Previously Thought

MM: At first glance this article makes one think that a particular group of doctors are defrauding CMS. This is not the case. The ones who are taking advantage of the system are Genentech, the manufacturers or Lucentis and the mis-guided actions of Senator Al Franken's office who think that they are working in the interest of patients. The reason that Senator Franken's office is misguided is that they are insistent that expensive, ready-made drugs that are 44 times more expensive than sterile compounded alternatives are a safer approach to treatment. The less expensive option for Age Related Wet Macular Degeneration (Wet AMG) is Avastin. It is made by the same drug company but is packaged in larger containers, indicated for breast and colon cancer; and must be transferred by a compounding pharmacist in an approved clean/sterile environment to be used by ophthalmologists. Mark Drugs performs this procedure and has successfully done so for more than a decade. We are doing our small part to fight waste in the CMS system. It is truly a shame that Genentech and Senator Franken are not.
Well-Heeled Healers: A Few Doctors Account for Large Chunk of Medicare Payouts
By Kelly Young
Roughly 2% of healthcare providers taking Medicare accounted for $15 billion in payouts — or almost a quarter of the $77 billion total — in 2012, according to a huge data set on payments to individual physicians released by the Centers for Medicare and Medicaid Services.
Other facts gleaned from the data, as reported by the New York Times:

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MM: Almost 85% of catheter associated UTI's are historically associated with E. coli infection. A potentially very effective preventative treatment of this is the use of oral D-mannose in either the powdered or capsule form. The simple ingestion of 2 grams (2 capsules or 1/2 teaspoonful) daily may be sufficient to prevent many of these infections. Here is an example of a very inexpensive ounce of prevention being worth at least a pound of cure. D-Mannose capsules and powder are available at Mark Drugs.
Guidelines on Preventing Catheter-Associated UTI's Updated
By Joe Elia
"Strategies to Prevent Catheter-Associated Urinary Tract Infections in Acute Care Hospitals" — a collaboration among several organizations — has been updated in Infection Control and Hospital Epidemiology.
The update outlines the principal risk factors for UTIs. Among the studies incorporated in the update was one showing that a reminder to staff that a catheter was in place, or the presence of a stop order to prompt catheter removal, reduced infection rates by half.
Recommended strategies are also outlined, along with an assessment of the strength of the supporting evidence.
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MM: I find it interesting that there continues to be great resistance in the general medical community regarding the benefits of vitamin D. I find it also interesting that D3 appears continually superior to D2 in clinical trials and that medical people are so surprised that a naturally occurring D3 is superior to a synthetic product. This is an inexpensive treatment that shows little to no risk or downside for the vast majority of patients who incorporate its supplementation into their daily regimen. It may well be the single most beneficial nutritional supplement that a person can take possibly equal only to a probiotic supplement.
Vitamin Doubt: Evidence Still Murky on D's Benefits
By Joe Elia
Two BMJ meta-analyses on vitamin D have found that evidence for benefit is narrow and that if there is a benefit, the form of supplementation has a bearing on its magnitude.
One, an "umbrella review" of meta-analyses and systematic reviews, found no "highly convincing" evidence linking circulating vitamin D levels with any of 137 outcomes, such as colorectal cancer or hypertension. It found a "probable" link for only three outcomes: birth weight, parathyroid hormone levels in dialysis patients, and dental caries in children.
The other meta-analysis found, in observational data, a salutary effect of increasing vitamin D levels on mortality. In randomized, controlled trials, the analysis found a significant mortality benefit from vitamin D3 supplements, but not from the D2 form.
Editorialists champion new trials focusing on risks as well as benefits of supplementation, and advise against measuring circulating vitamin D beyond bone-disease-related conditions.
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MM: Once again we see the confusion and prejudice against the use of nutritional products. My gut feeling is that these mis-interpretations of the data were accidental and non-malicious but I can't help but wonder why the criticism of fish oil and omega 3 fatty acids received so much traction in both the lay and professional press.
Dietary Fats: Corrected Meta-Analysis Raises a Fuss
By Joe Elia
A recent meta-analysis — reported here as an example of "the shaky underpinnings" of guidelines encouraging the intake of omega-3 fatty acids — has been corrected in the Annals of Internal Medicine, but not without raising a kerfuffle. A Science news story quotes nutritionist Walter Willett as calling for a retraction.
However, Rajiv Chowdhury, the first author on the Annals meta-analysis, has written in an email to Physician's First Watch that "these changes did not affect our overall conclusions of the paper."
According to the Science story, the meta-analysis wrongly concluded that one study on omega-3 fatty acids showed a slightly negative effect on coronary risk, whereas it had in fact shown a strong positive effect.
One of the paper's authors says the whole point is "there is no strong support for the guidelines and we need more good trials."
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MM: I am frequently asked what vitamins or nutritionals are beneficial for ADHD. As this seems to be a growing problem in adults and children, I am eager to seek viable treatments that do not inhibit creativity like most of the allopathic treatments for this condition do. This study indicates that the B vitamins, especially folic acid, B-6 and niacin may hold some of the answers. It would certainly make sense that these vitamins could be lacking in many of our daily diets as they are contained in green leafy vegetables, which are not favorite foods of many Americans.
Br J Psychiatry 2014 Jan 30
Micronutrient Treatment for Adult ADHD
A vitamin and mineral formula moderately improved symptoms, though clinician-rated effects were less consistent than patient-rated effects.
Attention-deficit/hyperactivity disorder (ADHD) in adults is disabling and can be difficult to treat. Specific medications are effective, but concerns about adverse effects have led to a growing interest in alternative-medicine approaches. Now, investigators in New Zealand have conducted a randomized, double-blind, controlled trial of a dietary intervention in 80 adults with rigorously diagnosed ADHD.
Participants received a manufacturer-supplied micronutrient formula containing all vitamins (except K) and 16 minerals (at 2–400 times the recommended daily allowance) or placebo for 8 weeks. Some individuals had comorbid depression or anxiety, but none were receiving psychiatric medication.
The formula was associated with significantly better self- and observer ratings, with medium-to-large effect sizes. On clinician ratings, only global functioning was improved. Significantly more micronutrient recipients than placebo recipients responded on at least one self- or observer-rated subscale (≥30% improvement in symptoms; 64% vs. 37%). A structured assessment of psychosocial functioning showed no change. Adverse events were negligible. Almost two thirds of patients in each group thought that they were receiving placebo.
Comment: This well-designed study showed a definitive signal of improvement in ADHD symptoms with the nutritional formula. Clinicians' limited exposure to a broad range of patient behaviors may account for their failure to notice the improvements seen by participants and observers. Limited functional effects may indicate only partial improvement, with problematic symptoms remaining (as also occurs with medication). This formula contained many substances (methylfolate, vitamin B6, niacin) known to affect monoamine neurotransmission, but the large number of substances limits investigation of the mechanism of action. Although derived from a single study and lacking information on the formula's long-term safety, these findings could justify a brief trial with the well-tolerated formula.
Citation(s): Rucklidge JJ et al. Vitamin-mineral treatment of attention-deficit hyperactivity disorder in adults: Double-blind randomised placebo-controlled trial. Br J Psychiatry 2014 Jan 30; [e-pub ahead of print].
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MM: Low-dose aspirin is a potentially inexpensive approach towards the prevention of preeclampsia. One of the prevailing fears of using aspirin in the latter phases of pregnancy has always been the risk to life due to diminished clotting following c-section or normal childbirth. The use of aspirin for preeclampsia, like all other treatments must be weighed against its potential benefits.
USPSTF Draft Recommendation Advises Aspirin for Women at Risk for Preeclampsia
By Kelly Young
The U.S. Preventive Services Task Force is recommending the use of low-dose aspirin (81 mg/day) to prevent preeclampsia in high-risk women. Previously, the group found insufficient evidence to recommend its routine use.
In a draft recommendation statement, the task force advises daily, low-dose aspirin after 12 weeks' gestation if a woman has one or more high-risk conditions, such as a history of preeclampsia, chronic hypertension, or diabetes, or has several moderate risk factors, including obesity, family history, and an age of 35 years or above.
Clinical trials found that aspirin reduced the risk for preeclampsia by 24%, preterm birth by 14%, and intrauterine growth restriction by 20%. There was no evidence of maternal or fetal harms with aspirin.
The authors write that aspirin's anti-inflammatory, antiangiogenesis, and antiplatelet properties could help explain its role in preeclampsia prevention.
The USPSTF's draft statement is open to public comment until May 5.
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MM: This relatively small study identifies a problem that is fairly far reaching in both pre-menopausal and post-menopausal women. The issue of vulvo-vaginal dryness, irritation, recurrent UTI's painful intercourse and other associated urogenital problems. Recently several prescription drugs have entered the market place and all of these carry significant lists of side effects. There is a non-prescription alternative, invented by Dr Renijie Chang of Arlington Heights, IL that addresses these concerns. It is called NeuEve. It is a vaginal suppository that may be used 1-2 times a week and has shown dramatic success for all of these urogenital problems. NeuEve is carried at Mark Drugs in Roselle and Deerfield.
Menopause 2014 Mar; 21:281
What Do Women Use for Perineal Hygiene and Vulvovaginal Symptom Relief?
In a small sample of postmenopausal women, about half used at least one OTC product promoted for feminine hygiene or vulvovaginal symptoms.
Many over-the-counter (OTC) products are promoted for “feminine hygiene” or relief of vulvovaginal symptoms, which are experienced by as many as 44% of postmenopausal women. Some products contain contact irritants (e.g., benzocaine, fragrances), promote possibly harmful practices (e.g., douching), or may be associated with gynecologic malignancies (talc). How commonly do women use such products? Investigators distributed questionnaires to postmenopausal women who sought routine gynecologic care at two U.S. clinics. Women with chronic or recurrent vulvar dermatoses, such as lichen sclerosus or genital herpes simplex virus, were excluded.
In all, 114 women (mean age, 66; 94% white) completed the questionnaires. About half reported using at least one OTC product during the previous 3 months, and about one third had used two or more products. Twenty-eight women reported using barrier products, most commonly petroleum- or zinc oxide–based ointments. Thirty-four women had used powders, typically talcum powder, and 14 had used topical anesthetics. Nine women reported douching, and 35 had used baby wipes for perineal cleansing. More than half reported using absorbent products (panty liners, pads, or adult diapers), and nearly half of the 50 sexually active women used an OTC lubricant for coitus.
Comment: This study included mostly white women; however, hygiene practices vary by race and ethnicity. In my practice, as in this sample, douching is not common, but women often use other over-the-counter products, not all of which (including plain petrolatum and zinc oxide ointments) have adverse effects. Nonetheless, we should be asking and educating about OTC products, especially if women have unexplained vulvovaginal signs or symptoms. In addition, systems that facilitate rapid appointments for acutely symptomatic conditions would enable prompt diagnosis and encourage specific treatment of vulvovaginal symptoms rather than use of OTC products to relieve symptoms.
Citation(s): Erekson EA et al. Over-the-counter treatments and perineal hygiene in postmenopausal women. Menopause 2014 Mar; 21:281. (http://dx.doi.org/10.1097/GME.0b013e31829a3216)

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MM: This is information that should be taken with a grain of salt. It is an observation that, at this point lacks any scientific support and must be regarded very carefully. Unfortunately, this is the inflammatory type of information that could make its way to class action law suits and the lay press without sufficient support.
Study Suggests Link Between Viagra and Melanoma
By Larry Husten
A new study provides early evidence showing an association between sildenafil (Viagra) and melanoma, though, like all observational studies, it is unable to demonstrate a cause-and-effect relationship.
The retrospective study, published in JAMA Internal Medicine, analyzed data from more than 25,000 men from the Health Professionals Follow-up Study. Men who had recently used sildenafil had nearly twice the risk for developing melanoma after adjustment for other risk factors. Men who had used sildenafil at any time faced a similar increase in risk. There was no significant association between erectile function by itself and melanoma.
The authors caution that their findings "should be interpreted cautiously and are insufficient to alter current clinical recommendations." An editorialist agrees that a prospective study will be required before clinical recommendations should be changed.
Adapted from CardioExchange.
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MM: Medical marijuana has been in the news a lot recently and its uses have been both lauded and demonized. Dr Sanjay Gupta recently had a series on CNN of shows on the use of medical marijuana called "Weed" and Weed 2". These were excellent shows and explained some of the otherwise little known uses and benefits of medical marijuana. They discussed some of the other components in marijuana that do not get a person high and that may be developed in specific cultivated plants. These CBD's and CBN's may be useful for pain, seizure disorders and a variety of other conditions. They have demonstrated benefits in children and the elderly and may be administered in transdermal creams, oral liquid concentrates or other dosage forms that do not require the traditional use of smoking apparatus.
AAN Guideline: Oral Cannabis May Help Ease MS Symptoms, Uncertainty Over Other Therapies
By Amy Orciari Herman
Clinicians may offer oral cannabis extract, tetrahydrocannabinol, or cannabinoid spray to patients with multiple sclerosis to ease patient-reported spasticity and pain (excluding central neuropathic pain), according to new guidelines on alternative therapies for MS from the American Academy of Neurology. Clinicians should counsel patients, however, that cannabis is likely ineffective at improving objective measures of spasticity.
Other conclusions based on an evidence review in Neurology include:

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MM: Although we've seen less reporting on C. Difficile in the professional and lay media of late, it is still a problem. This retrospective study identifies that 15% of all hospital acquired infections are from C. difficile. This becomes even more onerous when it is identified that these infections are commonly pneumonia and surgical site infections.
CDC Reports on Healthcare-Associated Infections
The CDC has released its estimates of healthcare-associated infections in the U.S. for 2011 in the New England Journal of Medicine.
For that year, the agency estimates there were some 720,000 hospital infections — the top two categories were surgical-site infections and pneumonia, with 158,000 infections each. Clostridium difficile was the most common pathogen in these infections, comprising roughly 15% of the total.
Device-associated infections (attributable to catheters and ventilators, for example) accounted for about 25% of all infections.
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MM: As we seek better measures of assessing health we are bound to discover contradictory data. This is the nature of research and discovery. I would not completely discount the long term value of HbA1c based upon these findings. I suggest that we will discover both, more support and criticism of these testing tools as time progresses.
Glucose Measurements Don't Improve Cardiovascular Risk Assessment
By Larry Husten
Adding glycemia measures to conventional cardiovascular risk assessment provides little additional prognostic information in those without diabetes or CVD, a JAMA study finds.
Researchers analyzed data on nearly 300,000 people without known diabetes or CVD from 73 prospective studies. They found that adding hemoglobin A1c, fasting glucose, random glucose, or postload glucose offered little improvement to standard cardiovascular risk assessment and did not help to better classify participants to inform decisions about preventive treatment.
One somewhat surprising finding: the four different measures of glycemia independently resulted in a J-shaped curve of cardiovascular risk — although lower glycemia levels were generally associated with lower levels of risk, at the extreme lowest level there was a rebound in risk.
The authors conclude: "Contrary to recommendations in some guidelines, the current analysis ... indicates that measurement of HbA1c is not associated with clinically meaningful improvement in assessment of CVD risk" in patients without known diabetes or CVD.
Adapted from CardioExchange
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MM: The bottom line is that if you are going to use a medication then you want one that will work and will both improve the quality and quantity of life. If that does not occur then the treatment must be questioned. the benefits of ARB's over ACE inhibitors (ACEi's) is that they do not have as much drowsiness or drug induced cough associated with them. If a person is diabetic and hypertensive then they need to look at the degree of discomfort that the ACE inhibitor causes before converting to an ARB.
ACE Inhibitors Linked to Better CV Outcomes Than ARB's in Patients with Diabetes
By Kelly Young
Angiotensin-converting–enzyme (ACE) inhibitors are associated with reduced mortality and cardiovascular events in patients with diabetes, while angiotensin-receptor blockers (ARBs) have little effect, according to a meta-analysis in JAMA Internal Medicine.
Researchers assessed the results of 35 randomized, controlled studies comprising some 56,000 patients. Participants had been randomized to either the active group (ACE inhibitors or ARBs) or a comparator group (placebo, no treatment, or other antihypertensive drugs).
Use of ACE inhibitors was associated with a 13% to 17% risk reduction in all-cause mortality, cardiovascular mortality, and major cardiovascular events. ARB users did not see a similar benefit. However, ARBs were associated with a 30% risk reduction in heart failure.
The authors conclude that ACE inhibitors "should be considered as first-line therapy to limit the excess mortality and morbidity in this population."
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MM: The allegedly compassionate use of epidural anesthesia during labor may actually cause more real distress to mother and child than it relieves. Does the relief of intense pain that is somewhat shorter in duration make up for the increased duration of labor and the consequent increased risk to the child? Unfortunately, as a man, I feel ill-equipped to make this decision. Only a mother/patient can determine their level and intensity of pain or discomfort and that same person should ultimately have the power to make the decision whether to use an epidural or not. That being stated, education of the mother-to-be is necessary so that she may make an informed decision.
Obstet Gynecol 2014 Mar; 123:527
Epidural Anesthesia Lengthens Labor's Second Stage More than Previously Thought
After receiving epidurals, women should be allowed as long as 2 additional hours to progress before obstetric intervention is considered.
Recent research has shown that fetal descent rates in labor may be slower than traditionally thought (NEJM JW Womens Health Mar 18 2014). Moreover, the evolution of obstetric practice has resulted in increasing use of epidural anesthesia. How have these variables affected the average duration of labor? Researchers at one academic hospital conducted a retrospective cohort study involving >42,000 singleton vaginal births from 1976 to 2008. Duration of the second stage of labor was characterized by calculating the median and 95th percentiles. Women were stratified by parity and use or nonuse of epidural anesthesia.
About half of the women received epidural anesthesia. In nulliparous women, median duration of labor's second stage was 47 minutes without epidural versus 120 minutes with epidural, and the 95th percentile for duration was 197 minutes without epidural versus 336 minutes with epidural. Among multiparous women, median duration was 14 minutes without epidural versus 38 minutes with epidural; 95th percentiles were 81 minutes versus 255 minutes.
Comment: The definitions for duration of labor's second stage should be reexamined in light of this large contemporary study. According to the authors, if the current standard of the American College of Obstetricians and Gynecologists were applied to this population, 31% of nulliparous participants and 19% of multiparous participants who received epidural anesthesia would have been identified as having prolonged second stage, possibly necessitating cesarean delivery. In general, such situations could be prevented by lengthening the progression standard to 2 additional hours for all women who receive epidurals.
Citation(s): Cheng YW et al. Second stage of labor and epidural use: A larger effect than previously suggested. Obstet Gynecol 2014 Mar; 123:527. (http://dx.doi.org/10.1097/AOG.0000000000000134)

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