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Content 7

 

The Doctor and the Pharmacist

Radio Show Articles:
January 4, 2014

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2000 Steps a Day May Keep the Doctor Away
A Different Way to Think About Chronic Pelvic Pain
Dietary Fiber Is Still Good for You
New Hypertension Guidelines Emphasize less Stringent Thresholds
Common Uterine Procedure May Cause cancer to Spread, Doctors Say
HbA1c and Severe Hypoglycemia in Type 2 Diabetes
Weight Concerns and Disordered Eating Common in 13-Year-Olds
Gluten Sensitivity Differs from Celiac Disease in Children
28 State AG's Ask FDA to Reconsider Approval of Zohydro ER Because of Abuse Potential
ADHD Overdiagnoses Fueled by Pharma Ads
FDA Advisors recommend New Grass Allergy Treatments
FDA Advisory Panel Recommends Approval of New Diabetes Drug
First Device for Migraine treatment Approved

MM: It's good to make New Year resolutions when it comes to life in general but it's especially good when it comes to your health. Unfortunately, we typically stop acting on those resolutions shortly after they are made. However, by having a method or game plan we will typically have greater success. This is a simple game plan towards more activity and better CV health. Just give it a try. You might be pleasantly surprised.
  
2000 Steps a Day May Keep the Doctor Away
By Amy Orciari Herman
Walking 2000 steps a day — about 20 minutes of moderate-intensity walking — can lower the odds of cardiovascular events among high-risk adults, according to an analysis from the NAVIGATOR trial published in the Lancet.
Researchers studied some 9300 adults aged 50 and older with existing cardiovascular disease or impaired glucose tolerance and at least one additional cardiovascular risk factor. Ambulatory activity was measured with a pedometer for 7 days at baseline and 1 year. During roughly 6 years' follow-up, 531 cardiovascular events occurred. Each 2000-step/day increment in ambulatory activity at baseline was associated with a roughly 10% lower risk for cardiovascular events. Similarly, each 2000-step increase in activity from baseline to 1 year was associated with an 8% lower risk, while each 2000-step decrease conferred an 8% higher risk.
Commentators say the trial "adds compelling and reassuring evidence for the benefits of physical activity on cardiovascular health."
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62061-9/abstract
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MM: Vaginal and pelvic pain is a problem that any woman of reproductive age may encounter but seems to be most prevalent in women who are 35 or older. Many women respond to hormonal treatments but just as many are sensitive toor concerned with the issue of potential cancers associated with hormonal treatments. For these women we offer a NON-HORMONAL Vagitory called NeuEve®. NeuEve® is not a prescription and may be used only occasionally or on a regular schedule to take care of vaginal pain, dryness, odor or diminished libido. This revolutionary new product can make the difference between comfortable, pleasurable intercourse and a painful experience that is dreaded for many women. Some of our patients have gone as far as to state that this product has "... saved their marriage". Please call Mark Drugs for more information.
  
Obstet Gynecol 2013 Nov; 122:1047
A Different Way to Think About Chronic Pelvic Pain
 Increased pain sensitivity may account for symptoms in some women with chronic pelvic pain. Diane
Chronic pelvic pain (CPP), experienced by as many as 20% of reproductive-age women, can be challenging to treat. Presence of CPP does not necessarily correlate with underlying pathology, such as endometriosis — and when endometriosis is identified, medical or surgical treatment may not alleviate the pain. Central nervous system amplification of pain processing, a factor in many chronic pain syndromes, might underlie pain perception in at least some women with CPP. In a quantitative test of pressure-pain sensitivity at a nonpelvic site (the nondominant thumbnail), researchers compared responses of 114 women with CPP or surgically confirmed endometriosis or both (35 with painless endometriosis, 15 with endometriosis and dysmenorrhea, 42 with endometriosis and CPP, and 22 with CPP only) with those of 30 pain-free women.
Women with CPP had significantly higher pressure-pain sensitivity than the comparison group (i.e., they reported faint, mild, and slightly intense pain with applications of lower pressures). Scores did not correlate with presence or severity of endometriosis or comorbid pain syndromes (fibromyalgia, irritable bowel syndrome, or migraine headaches). Scores were similar among women with endometriosis but no CPP and those in the healthy comparison group.
Comment: As the authors note, increased pain sensitivity in women with chronic pelvic pain could be caused by or result from their experiences with pain — and women with endometriosis but no CPP could be pain-free due to central nervous system adaptations that reduce pain perceptions. Regardless of the “which comes first” question, identifying women with centrally mediated CPP could lead to treatment with medical or cognitive behavioral therapies, thereby helping to avoid unnecessary surgeries.
Citation(s): As-Sanie S et al. Increased pressure pain sensitivity in women with chronic pelvic pain. Obstet Gynecol 2013 Nov; 122:1047.
(http://dx.doi.org/10.1097/AOG.0b013e3182a7e1f5)
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Dietary Fiber Is Still Good for You
By Joe Elia
Dietary fiber's salutary effects on health — specifically in preventing cardiovascular disease — are reaffirmed in a BMJ meta-analysis.
Researchers examined 22 cohort studies in predominantly Westernized countries that looked at the relation between fiber intake and cardiovascular risk. Most data were from food-frequency questionnaires. The analysis presents risks based on dose-response curves rather than simple "high" or "low" intakes.
Overall, total fiber intake was inversely associated with cardiovascular risk. Specifically, each 7 grams a day of fiber intake was associated with a risk ratio of 0.9 for both coronary heart disease and cardiovascular disease. Only insoluble fiber (wheat bran, brown rice, and other whole grains) had a significant lowering of risk.
Both the researchers and an editorialist acknowledge the limitations of dietary-recall studies. The editorialist writes that despite this, "clinicians should enthusiastically and skillfully recommend" more fiber in their patients' diets.
http://www.bmj.com/content/347/bmj.f6879
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MM: new guidelines will certainly make people less stressed that their health is in jeopardy. Over the past decade we have learned than more stringent blood pressure, blood sugar and cholesterol control have not translated into better health, lower morbidity or mortality rates. In fact, they have generally translated into more drugs, higher doses, increased adverse reactions and greater cost to society. I am happy about these new guidelines as more of my patients will fall into recommended ranges with some of the natural products that we can offer them. Please contact Mark Drugs to learn about some of our natural alternatives to improving your health.
  
New Hypertension Guidelines Emphasize less Stringent Thresholds
By Kelly Young
New hypertension guidelines from panel members of the Eighth Joint National Committee (JNC 8) recommend looser blood pressure treatment thresholds for older adults. The guidelines, published in JAMA, update JNC 7 recommendations from over a decade ago.
Drawing from randomized controlled trials, the group recommends that adults aged 60 and older should receive antihypertensive medications if their systolic BP is 150 mm Hg or higher or their diastolic BP is 90 or higher. This is a departure from previous recommendations.
Younger adults should begin drug treatment if their systolic BP is 140 or higher or their diastolic BP is 90 or higher. The 140/90 threshold applies to adults with chronic kidney disease or diabetes as well, also a change.
In nonblack patients, initial drug treatment should include a thiazide-type diuretic, calcium channel blocker (CCB), angiotensin-converting enzyme (ACE) inhibitor, or angiotensin-receptor blocker (ARB). For black patients, treatment should start with a thiazide-type diuretic or CCB. In adults with CKD, therapy should include an ACE-inhibitor or ARB.
Lifestyle interventions are still recommended for all patients. The guideline features an algorithm to guide physicians through treatment options.
Editorialists note that despite previous recommendations to target systolic BP below 140 mm Hg, only about half of Americans with hypertension are below this level. They hint that raising the threshold to 150 in older adults could potentially have significant public health consequences.
http://jama.jamanetwork.com/article.aspx?articleid=1791497
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Common Uterine Procedure May Cause cancer to Spread, Doctors Say
By Amy Orciari Herman
Four Boston physicians are seeking a moratorium on uterine morcellation — a common procedure used to eliminate fibroids laparoscopically — over concerns that it might cause undetected cancer to spread, the Wall Street Journal reports.
The WSJ says that in a draft article submitted to the New England Journal of Medicine, the physicians argue that a higher-than-expected number of women (nearly 1 in 400) have undetected cancer in their fibroids. Grinding the fibroids during morcellation, they say, can cause cancerous cells to spread in the abdomen, potentially tripling one's 5-year mortality risk.
The American Congress of Obstetricians and Gynecologists maintains that morcellation is "very low risk," the WSJ reports, and the group "has no immediate plans" to offer guidance on how physicians should counsel patients about the procedure.
http://online.wsj.com/news/articles/SB10001424052702304173704579264673929862850
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Diabetes Care 2013 Nov; 36:3535
HbA1c and Severe Hypoglycemia in Type 2 Diabetes
Hypoglycemia appears to be more common at both the lowest and highest glycosylated hemoglobin levels.
We generally assume that severe hypoglycemia occurs mainly in diabetic patients with the tightest glycemic control, manifested by low glycosylated hemoglobin (HbA1c) levels. An observational study derived from a survey of patients enrolled in the Kaiser Permanente Northern California system suggests otherwise.
About 9000 type 2 diabetic patients who were taking diabetes medications were asked whether they had experienced severe hypoglycemia (requiring assistance to treat the reaction) during the past year. Overall, 11% reported at least one severe hypoglycemic episode. In unadjusted analyses, the relative risk for severe hypoglycemia was highest among patients with HbA1c levels >9% (RR, 1.30, compared with HbA1c of 7%–8%). In fully adjusted analyses, risks for severe hypoglycemia were highest among patients with HbA1c levels <6% (RR, 1.25) or >9% (RR, 1.16). Both RRs fell just short of statistical significance.
Comment: This study suggests a U-shaped risk curve in which severe hypoglycemia is most likely to occur in treated diabetic patients with either the lowest or the highest glycosylated hemoglobin levels. Although the findings might seem surprising, they ring true in my experience — particularly among patients with high HbA1c levels who have marked fluctuations in day-to-day glycemic control. Although the reasons aren't always obvious, lability of glycemic control sometimes results from erratic patterns of eating and physical activity, erratic adherence to scheduled times of insulin administration, or both.
Citation(s): Lipska KJ et al. HbA1c and risk of severe hypoglycemia in type 2 diabetes. Diabetes Care 2013 Nov; 36:3535.
(http://dx.doi.org/10.2337/dc13-0610)
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MM: Obesity and Body Dysmorphia are two major concerns to Americans and their health. We know that these conditions effect adults and there is growing concern and evidence that our youth are threatened by this as well. Obesity causes both short and long term health problems but Body Dysmorphia had potentially crippling effects on a person's psyche and self image. This coupled with ill advised efforts to fit into society's image of the "ideal" body type can lead to serious physical and physiological problems. Is there a happy medium and how do we reach it? That is a question that health professionals and the public must ask and discuss. I do not believe that discussions should be avoided with our children on these important issues. Studies indicate that educating our youth on topics such as drug abuse opens the communication lines between children and parents and may deter our youth from making poor decisions. I believe that this same tool should be used when it comes to food choices, obesity and body image.
  
J Adolesc Health 2013 Dec 17
Weight Concerns and Disordered Eating Common in 13-Year-Olds
…and are associated with both short- and long-term negative outcomes.
Peak onset of eating disorders is between ages 15 and 19 years, but younger teens also display eating disorder symptoms. Investigators in England examined eating disorder symptoms during early adolescence in 7082 adolescents (50% girls; 96% white) enrolled in the Avon Longitudinal Study of Parents and Children. Height and weight were measured at ages 13 and 15 years. Parents completed a semi-structured interview designed to identify psychiatric disorders, including eating disorder behaviors and cognitions, and their effect on family and adolescent functioning.
By parental report, 12% of girls and 5% of boys at age 13 years were “terrified” about gaining weight or getting fat, and 5% of girls and 2% of boys were “upset or distressed a lot” about their weight or shape. Three patterns of weight concerns/eating behaviors emerged: bingeing/overeating, weight/shape concerns with weight control behaviors, and food restriction. Binging/overeating was associated with social impairment and family burden and emotional and behavioral disorders in both sexes. Weight concerns were associated with social impairment in both sexes and with family burden in girls. Food restriction was associated with all four negative outcomes in boys and with family burden and behavioral disorders in girls. Bingeing/overeating and weight concerns at age 13 were associated with higher body-mass index (BMI) z-scores at age 15 in both sexes, while food restriction predicted lower BMI-z scores.
Comment: Disordered eating and concerns about weight and shape are common among 13-year-old teens and associated with both short- and long-term negative outcomes. How best to minimize the emergence of these behaviors and cognitions and prevent progression to full-blown eating disorders is unclear, but some research suggests strategies that include focusing on healthy eating rather than dieting and avoidance of weight-based teasing or parental discussions of their own dieting behaviors (NEJM JW Pediatr Adolesc Med Feb 1 2012 and NEJM JW Pediatr Adolesc Med Jul 23 2008).
Citation(s): Micali N et al. Frequency and patterns of eating disorder symptoms in early adolescence. J Adolesc Health 2013 Dec 17; [e-pub ahead of print].
(http://dx.doi.org/10.1016/j.jadohealth.2013.10.200)
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J Pediatr 2013 Nov 16
Gluten Sensitivity Differs from Celiac Disease in Children
Some children with diarrhea and abdominal pain respond to a gluten-free diet without meeting criteria for celiac disease.
Gluten-associated disorders include celiac disease (CD) and wheat allergy, but another type of gluten sensitivity — different from celiac disease — has been reported in adults. This case series from a pediatric gastroenterology clinic describes 15 referred children (mean age, 9.6 years; 10 boys) who had adverse reactions to wheat ingestion but did not meet criteria for CD or wheat allergy based on tests for antigliadin, anti-tissue transglutaminase, and anti-endomysial antibodies; ferritin levels; hepatic transaminases; erythrocyte sedimentation rates; HLA typing; or small intestinal biopsies. These children were considered to have gluten sensitivity (GS).Gluten Sensitivity Differs from Celiac Disease in Children.
Gluten Sensitivity Differs from Celiac Disease in Children Children with GS presented with abdominal pain (80%), chronic diarrhea (73%), fatigue (33%), bloating (26%), headache (20%), and other general symptoms (see Table).Native antigliadin antibody IgG was positive in 66%. Discretionary intestinal biopsies in 11 children were normal or showed minimal inflammation. HLA typing identified DQ2 in 7 children in the GS group (and all children in a comparative CD group). No differences in nutritional, biochemical, or inflammatory markers were found between the GS group and a control group of children with functional gastrointestinal disorders.
Comment: Whether gluten sensitivity is a distinct disorder or a mild form of celiac disease is uncertain. Some children with chronic diarrhea or abdominal pain respond to a gluten-restricted diet. We need to learn more about how the two disorders are related.
Citation(s): Francavilla R et al. Clinical, serologic and histologic features of gluten sensitivity in children. J Pediatr 2013 Nov 16; [e-pub ahead of print].
(http://dx.doi.org/10.1016/j.jpeds.2013.10.007)
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28 State AG's Ask FDA to Reconsider Approval of Zohydro ER Because of Abuse Potential
By Kelly Young
Twenty-eight state attorneys general have asked the FDA to reconsider its approval of Zohydro ER, a hydrocodone-only painkiller, or consider an expedited schedule for developing an abuse-deterrent version.
In a letter to FDA commissioner Margaret Hamburg, they write that Zohydro ER is up to 10 times as potent as other hydrocodone products and currently does not contain any abuse-deterrent properties.
They refer back to the approval of other prescription painkillers like Oxycontin, which was also easy to abuse when it first entered the market and did not come with clear prescribing instructions. They write: "This created an environment whereby our nation witnessed a vicious cycle of overzealous pharmaceutical sales, doctors overprescribing the narcotics, and patients tampering with these drugs, ultimately resulting in a nationwide prescription drug epidemic claiming thousands of lives."
http://ag.ky.gov/pdf_news/zohydro-letter.pdf
  
http://www.jsonline.com/news/health/28-attorneys-general-ask-fda-to-reconsider-approval-of-zohydro-b99161911z1-235458491.html
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ADHD Overdiagnoses Fueled by Pharma Ads
By Amy Orciari Herman
The rising rates of ADHD diagnoses are "a national disaster" fueled largely by drug-company ads that target clinicians and parents alike, according to a front-page story in Sunday's New York Times.
"The zeal to find and treat every ADHD child has led to too many people with scant symptoms receiving the diagnosis and medication," reports the Times. The paper's analysis of CDC data found that ADHD trails only asthma as the most common long-term diagnosis in children.
And drug makers are even targeting the young: Adderall's manufacturer subsidized 50,000 copies of a comic book that features superheroes saying, "Medicines may make it easier to pay attention and control your behavior!" (If you ever wondered where the name Adderall came from, the pharma executive who introduced the drug in 1996 told the Times it's meant to convey "ADD [attention deficit disorder] for all.")
The Times story also delves into the debate around the dangers of stimulants, as well as the "new frontier" of ADHD in adults.
http://www.nytimes.com/2013/12/15/health/the-selling-of-attention-deficit-disorder.html?_r=0
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FDA Advisors recommend New Grass Allergy Treatments
By Amy Orciari Herman
FDA advisers voted on two new allergy immunotherapies last week, Reuters reports.
Grastek, a sublingual tablet, received a 9 to 0 vote in favor of its efficacy for treating Timothy grass pollen allergy in those aged 5 years and older. The advisers also agreed that Grastek is safe — as long as epinephrine is readily available to patients. Postapproval safety studies were recommended for its use in those aged 5 to 11 years, as side effects such as lip swelling and oral blistering have been noted.
A second sublingual tablet, Oralair, earned a 9 to 1 vote for its efficacy in those 5 years and up. It includes extracts from five grass pollens: Kentucky bluegrass, orchardgrass, perennial ryegrass, sweet vernal, and Timothy. Concerns were raised about its use in pregnant women and patients with asthma, and side effects in those under age 10 were discussed.
http://www.reuters.com/article/2013/12/12/us-merck-fda-allergy-idUSBRE9BB15Z20131212
  
http://www.reuters.com/article/2013/12/11/stallergenes-fda-allergy-idUSL3N0JQ2P820131211
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FDA Advisory Panel Recommends Approval of New Diabetes Drug
By Amy Orciari Herman
FDA advisers voted 13 to 1 on Thursday to recommend approval of the diabetes drug dapagliflozin, Reuters reports. The drug's mechanism of action — inhibition of the sodium-glucose transporter in the kidneys — leads to reduced renal glucose reabsorption and increased glucose excretion.
The advisory panel also voted 10 to 4 that dapagliflozin has a favorable cardiovascular risk profile. A potential excess of bladder cancers did raise a red flag for some advisers, with one saying the FDA should require the potential risk to be listed on the label. The same adviser, according to Reuters, said he "really" likes the drug, pointing out that it lowers blood pressure and enables weight loss.
In 2012, the FDA rejected dapagliflozin, citing concerns about potential heart and cancer risks. Last week's advisory panel vote, however, was based on results from new studies and longer-term data from prior trials.
Earlier this year, the FDA approved another drug with the same mechanism of action, called canagliflozin.
http://www.reuters.com/article/2013/12/12/us-bristolmyers-astrazeneca-diabetes-idUSBRE9BB19X20131212
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First Device for Migraine treatment Approved
By Kristin J. Kelley
The FDA has approved the first device to relieve migraine pain in patients aged 18 and older. The Cerena Transcranial Magnetic Stimulator is indicated for migraine with aura and is used after the onset of pain.
Patients hold the device to the back of their heads and press a button, which releases a pulse of magnetic energy that stimulates the occipital cortex. In a randomized study, 38% of patients with moderate-to-strong migraine headaches preceded by aura were pain-free 2 hours after using the device, compared with 17% of controls.
Single reports of aphasia, sinusitis, and vertigo were among the adverse reactions. The device may cause dizziness. Additionally, says the FDA, it should not be used by those with a family or personal history of seizures; implanted medical devices (e.g., pacemaker); or metals in the head, neck, or upper body.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378608.htm

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