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Content 7

 

The Doctor and the Pharmacist

Radio Show Articles:
November 9, 2013

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FDA Seeks to Ban Partially Hydrogenated Oils from Food
Healthy Diet By Middle Age Linked to Healthy Aging Women
Mediterranean Diet: Multiple Benefits
Depression, Inflammation, and Exercise: An Evolving Story
Sleep On It More
'Herbal' Supplements are Often Not As Advertised
Generic Drug Manufacturer Faked Test Results for FDA Approval
Testosterone Therapy Associated with Adverse Outcomes After Coronary Angiography
Where's It Been Hiding? New Knee Ligament Found
Outcomes After Total Knee Replacement
Guidelines Recommend Universal Screening for Diabetes at First Prenatal Visit
New Vaccine Produces Long-Term Elimination of Simian Immunodeficiency Virus
ACE Inhibitors, Angiotensin-Receptor Blockers Tied to Increase in Kidney Admissions
Speaking Two Languages Might Help Delay Dementia

FDA Seeks to Ban Partially Hydrogenated Oils from Food
By Amy Orciari Herman
Partially hydrogenated oils, the main source of trans fats found in processed foods, are not "generally recognized as safe" for consumption, the FDA said Thursday in a "preliminary determination."
If the determination is made final, partially hydrogenated oils will be labeled as food additives and will be banned from food products "unless authorized by regulation," the agency said. The statement is open for public comment for 60 days.
FDA commissioner Margaret A. Hamburg noted: "While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern." She adds that, "further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7000 deaths from heart disease each year."
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373939.htm
  
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MM: This article merely emphasizes the value of a healthy lifestyle. Drugs and nutritional supplements are all well and good; especially if a disease state is present but the old adage, 'an ounce of prevention is worth a pound of cure' still holds up and diet needs to be a cornerstone of that lifestyle. All too often, we engage in our wants and desires that end up hurting us and then we ponder why or how we got into a miserable state. I am just as guilty as the next person of being in denial about the things that I like such as rich food or fine beverages but if they cause a problem such as inflammation or weight gain, then I/we know that they must be avoided. After that it's my/our decision to pay attention or pay the piper.
  
Healthy Diet By Middle Age Linked to Healthy Aging Women
By Kelly Young
Women who eat healthy diets in midlife are more likely to live past age 70 and have fewer physical and cognitive maladies as they age, according to an analysis of the Nurses' Health Study published in the Annals of Internal Medicine.
Researchers calculated how closely some 11,000 middle-aged women (median age, 59) followed a healthy diet (high in fruits, vegetables, whole grains, legumes, polyunsaturated fatty acids, and nuts; low in red and processed meat and sweetened beverages; moderate alcohol intake). In addition, they estimated adherence to the Mediterranean diet, which also included fish intake.
After roughly 15 years, women in the top quintile of healthy diet scores had a 34% greater likelihood of being healthy agers (i.e., survival to age 70, free of 11 chronic diseases, no major cognitive or physical impairment) — and those in the the top quintile of Mediterranean diet scores had a 46% greater likelihood — compared with those in the bottom quintiles.
http://annals.org/article.aspx?articleid=1763229
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MM: Remember that it is not just about quantity but more so, Quality of Life. A Mediterranean diet seems to be protective against depression, stroke and cognitive impairment. These are three real strong reasons to take a closer look at a general modification of our individual lifestyles.
  
Ann Neurol 2013 Sep 16
Mediterranean Diet: Multiple Benefits
This meta-analysis confirms the diet's benefits in depression, stroke, and cognition.
The Mediterranean diet is characterized as high in vegetables, fruits, nuts, and seeds; moderate in fish, poultry, eggs, and olive oil; and low in red and processed meat and saturated fats. Although it is difficult to discern which element is important, the diet has been studied as a prototypic example of a “healthy diet” and has been the subject of multiple studies suggesting benefits in aging, cardiovascular risk factors, and mood.
The current report is a meta-analysis of 22 studies examining the effect of the Mediterranean diet on stroke, cognitive impairment, and depression. High adherence to the diet was associated with a protective effect for stroke (pooled relative risk, 0.71), depression (PRR, 0.68), and cognitive impairment (PRR, 0.60).
Comment: The meta-analysis gives more power to the observation of the health benefits with the Mediterranean diet. We do not know whether the mechanism is related to anti-inflammatory or antioxidant properties or some other cause, such as glucose regulation (NEJM JW Psychiatry Nov 1 2013). Although we cannot dissect the relevant beneficial components of the Mediterranean diet, its principles are valuable and practical for lifestyle guidance.
Citation(s): Psaltopoulou T et al. Mediterranean diet, stroke, cognitive impairment, and depression: A meta-analysis. Ann Neurol 2013 Sep 16; [e-pub ahead of print].
(http://dx.doi.org/10.1002/ana.23944)
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MM: It has been said that "Inflammation may be the cause of all disease." The more I look at chronic diseases, the more I tend to agree with this theory.
  
Mol Psychiatry 2013 Oct; 18:1119
Depression, Inflammation, and Exercise: An Evolving Story
In depressed patients not responding to medication, higher TNF levels predict response to exercise, and greater improvement in depression correlates with greater changes in another cytokine.
Depression has been associated with higher levels of pro-inflammatory cytokines such as interleukin (IL) 6 and tumor necrosis factor α (TNF; e.g., NEJM JW Psychiatry Mar 29 2010). In addition, selective serotonin reuptake inhibitors (SSRIs) lower cytokines, such as Il-1β, and elevated TNF levels seem to predict resistance to SSRI treatment. In the current randomized study, 73 depressed patients with inadequate SSRI response started a 12-week, adjunctive exercise program at low or high intensity. Cytokine levels were examined at baseline and post-treatment.
Higher levels of TNF at baseline predicted better depression scores at week 12. Degree of depression improvement was associated with change in Il-1β, but this association was significant only in the high-exercise group. Exercise did not significantly change overall levels of the tested cytokines (TNF, Il-1β, Il-6, and interferon-γ).
Comment: Previous studies have suggested the existence of an “inflammatory” type of depression (NEJM JW Psychiatry Oct 15 2012). If this does exist, the current results suggest that exercise works differently from antidepressants — because higher cytokine levels predict response to exercise but not response to antidepressant medication. Given the growing research data supporting an antidepressant effect of exercise, this biological finding gives heft to suggestions that it be considered in nonresponsive patients who are able to undertake such a program.
Citation(s): Rethorst CD et al. Pro-inflammatory cytokines as predictors of antidepressant effects of exercise in major depressive disorder. Mol Psychiatry 2013 Oct; 18:1119
(http://dx.doi.org/10.1038/mp.2012.125)
  
http://www.ncbi.nlm.nih.gov/pubmed/22925832?access_num=22925832&link_
type=MED&dopt=Abstract

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MM: We know that the mind may be more accepting during sleep cycles than while awake. There are also studies that demonstrate the benefits of hypnotherapy and suggestion. It makes sense that subconscious introduction of emotional or anti-fear therapy may show similar benefits. I would be curious to see if this approach is beneficial to victims of PTSD.
  
Nat Neurosci 2013 Sep 22

Sleep On It More
Sleep may provide a unique opportunity to promote retention of fear extinction.
During extinction training, the memory of conditioned fear is labile. Animal research suggests that rapid-eye-movement sleep in this phase promotes retention of fear extinction (NEJM JW Psychiatry Apr 22 2013). In the current study, 15 normal subjects underwent fear conditioning by seeing a specific face while experiencing an electric shock and a background odor. Participants showed increases in skin conductance and in activity in the orbitofrontal cortex, insula, anterior cingulate cortex (ACC), and hippocampus on functional magnetic resonance imaging.
After conditioning, subjects took a nap (average duration, 73 minutes). During the 17 minutes of slow-wave sleep, the previously presented odor was presented again but without the shock. The subjects did not awaken or, later, identify the odor; however, fear extinction was reinforced, and activity in the hippocampus, insula, and ACC returned to normal. Exposure to other odors and other stimuli did not have this effect. Activation patterns in the left amygdala were different between presleep exposure to the odor and postsleep exposure.
Comment: Exposure to a context in which fear conditioning occurred (i.e., the odor) without the conditioned stimulus during slow-wave sleep appears to have promoted fear extinction by substituting a new memory in the amygdala for previously stored memories in the hippocampus, insula, and anterior cingulate cortex, without the subject's conscious awareness. A variation of prolonged exposure to contextual cues during slow-wave sleep may be helpful to promote fear extinction in patients with post-traumatic stress disorder.
Citation(s): Hauner KK et al. Stimulus-specific enhancement of fear extinction during slow-wave sleep. Nat Neurosci 2013 Sep 22; [e-pub ahead of print].
(http://dx.doi.org/10.1038/nn.3527)
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MM: It is important that an herbal supplement comes from a company that is able to provide assay information of its components. Companies must take responsibility to get this data from manufacturers in order to protect consumers and to be certain that what they purport to be providing is indeed present. Mark Drugs does this for our customers and patients. All of our nutritional and herbal product manufacturers will make certificates of assay available for the products that we sell.
  
'Herbal' Supplements are Often Not As Advertised
By Joe Elia
Patients may ask about a study concluding that herbal supplements might not be as herbal as advertised. The findings, published in BMC Medicine, got front-page coverage on the New York Times website.
Using DNA analysis, researchers tested the authenticity of 44 products from a dozen companies. The DNA signatures were compared with samples obtained from horticultural greenhouses.
The result? More than half the products contained plant species not listed on the label, and one third had a product "substitution" (the advertised ingredient was not even present). One product labeled as St. John's wort actually contained senna — a laxative. A Ginkgo product was contaminated with a tree nut — dangerous for people with nut allergies. Another contaminant, feverfew, can react with warfarin and aspirin and increase the risk for bleeding.
The study authors point out that there are currently no standards for authenticating herbal products.
http://www.biomedcentral.com/content/pdf/1741-7015-11-222.pdf
  
http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html?_r=0
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Generic Drug Manufacturer Faked Test Results for FDA Approval
About 80% of the drugs prescribed today are generic drugs, many of which are made in India. A leading manufacturer, Ranbaxy, often skipped the required steps for approval of its generic drugs. In 2008, Ranbaxy was prohibited by the FDA from shipping drugs to the U.S. from two Indian plants; however, the company continued to sell drugs in the U.S. from its other Indian facilities. In 2011, while the FDA was investigating Ranbaxy for serious criminal violations, the FDA was approving the company for the exclusive rights to make the generic version of one of the most popular pharmaceuticals of all time: Lipitor. This reportedly earned the company $600 million in the first six months. The federal investigation led Ranbaxy to plead guilty to seven felonies; Ranbaxy was bought by the Japanese firm Daiichi Sankyo in 2008.
http://www.cbsnews.com/8301-18563_162-57610994/leading-generic-drug-maker-faked-test-results-for-fda-approval/
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Testosterone Therapy Associated with Adverse Outcomes After Coronary Angiography
By Amy Orciari Herman
Testosterone supplementation is associated with a significantly increased risk for cardiovascular events among older male angiography patients, according to a retrospective study in JAMA.
Researchers examined outcomes among some 8700 veterans who'd undergone coronary angiography and had total testosterone levels below 300 ng/mL. Some 14% began testosterone therapy (usually patch or injection) at a median 1.5 years after angiography.
At 3 years, the primary outcome — a composite of all-cause mortality, MI, and ischemic stroke — had occurred in 26% of the testosterone group and 20% of the untreated group. After adjustment for coronary artery disease and other confounders, the relative risk for the primary outcome was 30% higher with testosterone therapy.
Harlan Krumholz, a cardiologist with NEJM Journal Watch, commented: "Amid the onslaught of ads promoting testosterone, this study provides cautionary information — and reminds us that chasing surrogate outcomes, like testosterone levels, may actually cause harm. We need outcomes studies to understand better the safety of these products
http://jama.jamanetwork.com/article.aspx?articleid=1764051
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Where's It Been Hiding? New Knee Ligament Found
By Joe Elia
First-year med students, despair. There's a new body part — a ligament on the anterolateral aspect of the human knee. It's called, plainly enough in the Journal of Anatomy, the anterolateral ligament.
Its origin is "at the prominence of the lateral femoral epicondyle, slightly anterior to the origin of the lateral collateral ligament." It acts, the authors speculate, "to control internal tibial rotation and thus to affect the pivot shift phenomenon."
(The structure is so well hidden that its debut online in August escaped our notice.)
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J Bone Joint Surg Am 2013 Oct 16; 95:1833
Outcomes After Total Knee Replacement
Coexisting hip and back pain detract from functional outcomes after knee replacement.
Although total knee replacement (TKR) clearly improves function and reduces pain in properly selected patients, benefits sometimes fall short of expectations. In this prospective cohort study, researchers sought to determine the effect of coexisting orthopedic problems on patient-reported outcomes in 180 patients who underwent TKR.
Before TKR, about half the patients suffered moderate-to-severe pain in one or both hips, the contralateral knee, or the low back. In analyses adjusted for age, sex, and body-mass index, having preoperative pain in any of those locations predicted poorer overall physical function at 6 months after TKR. In general, the greater the preoperative pain at any non-TKR site and the greater the number of painful non-TKR sites, the poorer the functional outcomes after TKR. Comment This study indicates that at least some of the variability in patient-reported outcomes after total knee replacement is attributable to coexisting pain in the hips, low back, and contralateral knee. When primary care clinicians consider referring patients for possible TKR, they should assess whether extensive arthritis is present in other weight-bearing sites and should advise patients with substantial pain in those sites that quality-of-life gains after knee surgery might be somewhat limited. When both hip and knee replacements are being considered, the hip generally should be replaced before the knee.
Citation(s): Ayers DC et al. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: The need for a musculoskeletal comorbidity index. J Bone Joint Surg Am 2013 Oct 16; 95:1833.
(http://dx.doi.org/10.2106/JBJS.L.01007)
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Guidelines Recommend Universal Screening for Diabetes at First Prenatal Visit
By Kelly Young
The Endocrine Society has published a set of guidelines regarding diabetes and pregnancy in the Journal of Clinical Endocrinology and Metabolism.
Among the recommendations:

http://jcem.endojournals.org/content/98/11/4227.abstract
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Nature 2013 Oct 3; 502:100
New Vaccine Produces Long-Term Elimination of Simian Immunodeficiency Virus
A vaccine given to monkeys just before infection seemed to induce adaptive immunity.
Although immunization might be able to prevent new infection with simian (monkey) immunodeficiency virus (SIV) or HIV, experts have assumed that, at best, immunization could do no more than keep the viral burden low in those already infected. Few people imagined that established infection might be curable by immunization, but a new study suggests otherwise.
A multi-institutional team inoculated monkeys with a vaccine containing both monkey cytomegalovirus and SIV sequences (CMV/SIV vector). Then, they infected the monkeys with SIV via rectal, vaginal, and intravenous routes. The virus reached local lymph nodes and distant tissues (e.g., spleen) despite the immunization. However, during 1 to 3 years of follow-up, many (but not all) of the immunized monkeys exhibited progressively lower levels of virus in blood and tissues. In some monkeys, no virus was detectable in blood or tissues.
  
Comment: The demonstration that a particular type of vaccine might induce adaptive immunity leading to clearance of a primate immunodeficiency virus is surprising and encouraging. Of course, these results in monkeys might not hold up in humans. Furthermore, in these experiments, monkeys were immunized shortly before being exposed to the virus. We don't know whether this type of vaccine would effectively combat long-established infections.
  
Citation(s):Hansen SG et al. Immune clearance of highly pathogenic SIV infection. Nature 2013 Oct 3; 502:100.
(http://dx.doi.org/10.1038/nature12519)
  
http://www.ncbi.nlm.nih.gov/pubmed/24025770?access_num=24025770&link_
type=MED&dopt=Abstract

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MM: I see another problem here besides that of Dr.Krumholz. ARB’s and ACE Inhibitors have been considered the anti-hypertensive of choice for patients with kidney disorders. These findings, if substantiated could shift a paradigm of prescribing for hypertension patients.
  
ACE Inhibitors, Angiotensin-Receptor Blockers Tied to Increase in Kidney Admissions
By Amy Orciari Herman
Increases in prescriptions for angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) in recent years may have contributed to an increase in hospital admissions for acute kidney injury, according to a PLoS ONE study.
U.K. researchers examined national prescription and hospital admission data from April 2007 through March 2011. Nationwide, ACE-inhibitor and ARB prescriptions increased by about 16% — and admissions for acute kidney injury by 52% — over the study period. In addition, there was "strong evidence" that increases in ACE-inhibitor and ARB prescriptions within particular general practices corresponded to increases in kidney hospitalizations within those practices. The researchers calculate that increases in such prescriptions accounted for 15% (roughly 11,000) of the overall rise in kidney admissions.
Cardiologist Harlan Krumholz of NEJM Journal Watch commented: "This ecological analysis should be interpreted cautiously, as the researchers were limited in their ability to link the use of ACE inhibitors and ARBs by individual patients with an increase in risk. This does not mandate a change in practice. What I find most concerning is the increase in acute kidney injury — and there is an urgent need for patient-level studies to determine what is fueling the elevation in risk."
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0078465
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Speaking Two Languages Might Help Delay Dementia
By Amy Orciari Herman
Bilingual patients might develop dementia nearly 5 years later than their monolingual peers, according to a Neurology study.
Researchers in India studied 650 patients diagnosed with dementia; 60% spoke two or more languages fluently before diagnosis. Bilingual patients were significantly older than monolingual patients when the first symptoms of dementia emerged (65.6 vs. 61.1 years). A protective effect was seen for Alzheimer's dementia, frontotemporal dementia, and vascular dementia. A benefit was also noted among illiterate patients, "demonstrating that bilingualism effects cannot be reduced to differences in education," the authors write.
Asked to comment, Brandy Matthews, a neurologist with NEJM Journal Watch, wrote: "In light of the 'cognitive reserve hypothesis' and delay in dementia onset, the dissociation of literacy from the number of languages used is compelling and may have implications beyond the scope of neurodegenerative disease, including how languages are taught, and possibly more importantly, used around the world."
http://www.neurology.org/content/early/2013/11/06/01.wnl.0000436620.33155.a4.abstract

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